Expl Ained &: Expanded

ISO 9001:2008
E XP L A I NE D &
EXPANDED
Making Your Quality Management
System Sustainable
Charles A. Cianfrani
John E. “Jack” West
ISO 9001:2008
Explained and
Expanded
H1446_Cianfrani_pi_000.indd 1 11/2/13 11:33 AM

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Charles A. Cianfrani, Joseph J. Tsiakals, and John E. (Jack) West
How to Audit the Process Based QMS, Second Edition
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Cracking the Case of ISO 9001:2008 for Manufacturing
John E. (Jack) West and Charles A. Cianfrani
Cracking the Case of ISO 9001:2008 for Service
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ISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third Edition
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ISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-By-
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The ASQ Auditing Handbook, Fourth Edition
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ISO 9001:2008
Explained and
Expanded
Making Your
Quality Management System
Sustainable
Charles A. Cianfrani
John E. (Jack) West
ASQ Quality Press

Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203
© 2014 by ASQ
All rights reserved.
Printed in the United States of America
19 18 17 16 15 14 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Cianfrani, Charles A.
ISO 9001:2008 explained and expanded : making your Quality Management
System sustainable / Charles A. Cianfrani, John E. (Jack) West.
pages cm
Includes bibliographical references and index.
ISBN 978-0-87389-866-9 (alk. paper)
1. ISO 9001 Standard. 2. Quality control—Standards. I. West, Jack, 1944–
II. Title
TS156.6.C45155 2014
658.4′013—dc23
2013038425
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Printed on acid-free paper

Contents
List of Figures and Tables. . . . . . . . . . . . . . . . . . . . . . . . . ix

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv
Chapter 1 Why Bother with Conformity?. . . . . . . . 1

Why Should an Organization Want to
Expand Beyond the Minimum
Requirements of ISO 9001:2008?. . . . 4
Where and How to Start the Journey. . . . . 5
A Few Processes That Deserve
Special Attention. . . . . . . . . . . . . . . . . 12
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Chapter 2 Building Your Quality Management

System. . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Basics of Process Management. . . . . . . . . 20
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Chapter 3 Why Is Quality Auditing Important?. . . 31

The Basics—A Summary . . . . . . . . . . . . . 33

vi Contents
The Distinction between Audit,

Self-Assessment, and Management
Review. . . . . . . . . . . . . . . . . . . . . . . . . 36
What Are the Minimum Requirements
for Auditing?. . . . . . . . . . . . . . . . . . . . 38
Tips on How to Pass an ISO 9001:2008
Certification Audit. . . . . . . . . . . . . . . . 40
Going Beyond the Minimum?. . . . . . . . . . 41
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Chapter 4 What Is Needed to Be Successful. . . . . . 47

Addressing Effectiveness (Capability
and Capacity) and Efficiency
(Waste Elimination). . . . . . . . . . . . . . . 47
Addressing Competence: Embedding
Learning as a Formal Process . . . . . . . 48
Product and Process Validation. . . . . . . . . 49
Addressing Correction, Corrective
Action, and Preventive Action. . . . . . . 56
Managing Incremental and Breakthrough
Improvement . . . . . . . . . . . . . . . . . . . . 62
The Relationships among Policy,
Objectives, and Alignment. . . . . . . . . . 63
Simplicity and Systems Thinking . . . . . . . 69
Manage by Facts: The Importance of
Obtaining and Analyzing Data. . . . . . . 74
“Output Matters” as a Core Value. . . . . . . 77
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Chapter 5 Go Beyond Where It Matters. . . . . . . . . 81

How to Conduct a Self‑Assessment:
A Primer. . . . . . . . . . . . . . . . . . . . . . . . 82

Contents vii
Where Can Self-Assessment Results

Indicate a Need to Go Beyond
Minimum Requirements?. . . . . . . . . . . 90
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Chapter 6 Future Quality Management System

Challenges. . . . . . . . . . . . . . . . . . . . . . . . . 107
The Communication Challenge. . . . . . . . . 108
Planning for the Future . . . . . . . . . . . . . . . 112
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Chapter 7 Revitalizing Your Quality

Management System. . . . . . . . . . . . . . . . 123
The Stable State. . . . . . . . . . . . . . . . . . . . . 123
How the System Should Work. . . . . . . . . . 124
People and the Quality System . . . . . . . . . 127
A Role of Management Review. . . . . . . . . 129
Set the Bar. . . . . . . . . . . . . . . . . . . . . . . . . 131
Each Employee’s Role. . . . . . . . . . . . . . . . 132
Shared Vision. . . . . . . . . . . . . . . . . . . . . . . 134
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Epilogue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Appendix Questions an Assessor Can Consider
in Planning and Conducting a
Self‑Assessment to the Contents of
ISO 9004:2009 . . . . . . . . . . . . . . . . . . . 139
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

List of Figures and Tables
Figure I.1 Model for the content of ISO 9001:2008

Explained and Expanded. . . . . . . . . . . . . . xvi
Figure 1.1 Output matters. . . . . . . . . . . . . . . . . . . . . . 2
Table 1.1 Characteristics of incremental and
breakthrough improvements . . . . . . . . . . . 14
Figure 1.2 Incremental and breakthrough
improvement . . . . . . . . . . . . . . . . . . . . . . . 15
Figure 2.1 Process: A set of interrelated or
interacting activities that transform inputs
into outputs. . . . . . . . . . . . . . . . . . . . . . . . 20
Figure 2.2 Processes are supported by resources and
controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Figure 2.3 An organization’s process model. . . . . . . . 23
Figure 2.4 A family of well-managed processes. . . . . 24
Figure 2.5 Process relationship of ISO 9001:2008
to ISO 9004:2009. . . . . . . . . . . . . . . . . . . . 27
Figure 3.1 The audit process. . . . . . . . . . . . . . . . . . . . 35
Figure 3.2 Conducting the audit . . . . . . . . . . . . . . . . . 35
Figure 3.3 Audit inputs and outputs, resources
required, and management role. . . . . . . . . 39
Figure 4.1 Validation that product designs meet
customer requirements—summary of
requirements. . . . . . . . . . . . . . . . . . . . . . . . 51
Figure 4.2 Design controls illustrated. . . . . . . . . . . . . 52
ix

x List of Figures and Tables
Figure 4.3 Appropriate attitudes and actions. . . . . . . . 61

Figure 4.4 The role of management review in
improvement . . . . . . . . . . . . . . . . . . . . . . . 64
Figure 4.5 Measure process parameters that drive
process output results. . . . . . . . . . . . . . . . . 65
Table 5.1 Performance maturity levels . . . . . . . . . . . 86
Table 5.2 Example of reporting self-assessment
results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Table 6.1 Conference Board CEO Challenge 2012:
Synopsis of survey results. . . . . . . . . . . . . 113
Figure 6.1 Forces affecting the future of quality. . . . . 114
Figure 7.1 Considerations for sustaining growth . . . . 126

Preface
S
urvival and sustainability are the key topics of this
book. It is intended to encourage quality professionals
to examine the structure and deployment of the quality
management system (QMS) of an organization—to expand its
breadth, depth, and objectives beyond mere compliance with
the requirements of a standard (even a very good standard) and
to aspire to world-class performance levels. While this book
addresses what an organization can do to meet the intent of
ISO 9001, its purpose is to discuss the importance of how the
requirements are met and what activities may be appropriate
beyond just meeting minimum requirements. While it dis-
cusses why an organization should consider compliance with
ISO 9001 and what needs to be done to pass an audit, most
of the book addresses activities that need to be considered for
sustainability. Many of these activities are beyond the scope of
ISO 9001 but are critical for survival and sustainability. Also
included are a chapter that considers the future of quality from
the perspective of both quality experts and CEOs, and a chap-
ter of activities to encourage the ongoing revitalization of the
organization’s QMS.
Since its initial release in 1987, the ISO 9001 standard has
been embraced by a wide range of organizations—large and
small, for profit and n ot-for-profit, regulated and not regulated,
and in many different industries throughout the world. Why
xi

xii Preface
such widespread recognition and use of this standard? Users

see it as a reasonable foundation for an effective QMS because
it can promote internal control of process performance and
improve operating effectiveness while enhancing customer sat-
isfaction. Since 1987 over 1 million organizations worldwide
have chosen to have their QMS certified to the requirements of
ISO 9001 by independent accredited registrars.
Such certification activity is both a blessing and a curse.
For many organizations, once certification is achieved, there is
an attitude that no more effort is needed to improve the QMS.
Such an attitude is contrary to both the explicit requirements of
ISO 9001 and its intent.
We can assure you that the requirements of the standard
were intended to establish a firm QMS foundation based on a
minimum number of requirements. This intention has persisted
throughout the several updates of the standard over the past
25‑plus years and is even more pronounced in 2013 as ISO
develops the next update, scheduled for release around 2015.
An operative but often overlooked word in the description
of the content of the ISO 9001 standard is minimum. All users
of the standard should realize that achieving compliance by
conforming to a minimum set of requirements is only a starting
point.
If an organization aspires to be in existence for five years
or more, then work must continue to not only eliminate any
causes of day-to-day nonconformity but also improve process
effectiveness and efficiency. And even that is not enough! In
addition to assiduous pursuit of corrective action, preventive
action, and improvement, the organization needs to seek ways
to expand both the breadth and depth of quality management.
This mentality is what is intended by clause 8.5—Improve-
ment. Quality management should be a continual migra-
tion of processes and controls in order to target and achieve
best-in-class performance levels. Such an approach to quality

Preface xiii
management will be a vital contributor to the sustainability of

the organization.
This book is intended to provide quality professionals
with the tools and directions to lead the effort to make qual-
ity management both a tactical and strategic tool in achieving
sustainability.
Charlie Cianfrani
Jack West
May 2013

Introduction
T
his book is intended to provide users of ISO 9001:2008
Explained1 with guidance that can help an organization
build a robust, sustainable QMS that focuses on achiev-
ing sustained success over time. But you need not have used
that book or even been certified to ISO 9001 to derive benefit
from this book. Figure I.1 provides a model for the contents of
this book. There are several categories of potential users of this
book:
• Users whose organizations are not yet certified to ISO
9001:2008 but need to be can benefit from using this
book along with ISO 9001:2008 Explained as they imple-
ment their QMS (see Chapters 1–4)
• Users who do not need certification but want a more
robust and efficient QMS can use this book without refer-
ence to ISO 9001:2008 Explained (see Chapters 3–6)
• Users already certified to or compliant with ISO
9001:2008 can gain greater QMS efficiency and organi-
zational sustainability by using this book along with ISO
9004:2009, Quality management systems—Managing for
the sustained success of an organization2 and Unlocking
the Power of Your QMS: Keys to Business Performance
Improvement 3 (see Chapters 4–7)
xv

xvi Introduction
The future
of quality
Why? (1) (5)
Need to continually
revitalize the QMS (7)
ISO 9001 ISO 9001++ (6)
QMS elements What we need to do What we need to do

to consider (2) to pass an audit (3) to be successful (4)
Figure I.1 M
odel for the content of ISO 9001:2008 Explained and
Expanded.
One of the pioneers of quality management and statistical

thinking observed many years ago that all models are wrong
but some are very useful. Keep the model represented in Fig-
ure I.1 in mind as you contemplate the state and content of your
QMS and the actions you can take to improve its breadth, the
depth of its implementation, and its role in ensuring the sus-
tainability of your organization.
Notes
1. C. A. Cianfrani, J. J. Tsiakals, and J. West, ISO 9001:2008
Explained, 3rd ed. (Milwaukee, WI: ASQ Quality Press, 2009).
2. ISO 9004:2009, Quality management systems—Managing for
the sustained success of an organization (ISO/TC 176/SC 2,
2009).
3. J. West and C. A. Cianfrani, Unlocking the Power of Your QMS:
Keys to Business Performance Improvement (Milwaukee, WI:
ASQ Quality Press, 2004).

1
Why Bother with
Conformity?
W
hy should an organization want to ensure effective
conformity with ISO 9001? Over the past 25 years
the answer to this question has become clear:
• ISO 9001 has been embraced as an international model
for quality management system (QMS) requirements,
with over 1 million certified user organizations in over
100 countries!
• ISO 9001 has morphed from a set of requirements that
focused on procedures and documents to one that focuses
on system output through process management. It is the
output of the system that matters.
• An ISO 9001–conforming system has the potential of
yielding output to delight customers.
• Customers do care whether an organization can demon-
strate conformity with ISO 9001 requirements, but they
care more about the output! Figure 1.1 illustrates this
concept.
• Conformity with ISO 9001 requirements has demon-
strated an ability to improve operating effectiveness and
even efficiency, as long as the organization honors the
intent of the requirements rather than just making a mini-
mum effort to pass an audit.
Chapter One

2 Chapter One
Context of the
organization
QMS improvement
Customer requirements
Leadership, planning, support,
Customer satisfaction
and resource management
Performance evaluation
and feedback
Operational planning and control

Product (and/or service) realization
Figure 1.1 Output matters.
In addition, it has become apparent that workers like ISO 9001

because it makes life simpler for them. In an ISO 9001 system,
workers have:
• A better understanding of what to do and how to do it
• The ability to ensure that their work meets requirements
• The ability to adjust processes when results do not meet
requirements
• An increased opportunity to communicate problems in a
nonthreatening manner
• An environment where they are not blamed for issues that
can only be resolved by managers
Middle managers have embraced ISO 9001 because it has
contributed to better control of processes and a higher level of

Why Bother with Conformity? 3
consistency in activities throughout the organization. Middle

managers find that ISO 9001 has:
• Made it easier to manage using facts and data rather than
opinions
• Enhanced communication throughout the organization—
between management and workers, between departments,
and with executive management
• Encouraged clarification of responsibility and accountability
• Standardized the way things are done, reducing variabil-
ity and making it easier to solve problems
• Fostered continual improvement as a core value and pro-
vided a platform for moving to performance excellence
Many top managers believe that adopting a formal ISO 9001
QMS has contributed to the focus of the organization on meet-
ing objectives. Top managers find that ISO 9001 has:
• Improved their organization’s ability to understand and
meet customer requirements in a consistent manner
• Brought greater clarity to the goals and objectives of the
organization
• Helped align all employees and processes to meet objec-
tives
• Improved bottom-line performance by enhancing rev-
enue and reducing costs
• Created a competitive advantage in some markets
• Facilitated competing in markets where other potential
suppliers are not registered
• Provided a framework that is useful for managing their
organization—or at least the operations part of it
Conformity may not be enough to ensure sustainability, but it is
a starting point. The current reality is that an organization must

4 Chapter One
be able to demonstrate conformity with ISO 9001 in order to

be competitive.
To summarize, here are some of the reasons an organization
should want to ensure effective conformity with ISO 9001:
• It is a proven model for effective management
• It provides a foundation for improving both effectiveness
and efficiency
• It can provide differentiation from competition or at least
will not preclude consideration as a credible source for
products and services
• Customers, market conditions, or regulations may require
conformity
• The requirements address activities that add value to the
organization
Perhaps the most important reason for conforming to ISO
9001 is survival. If an organization does not have a founda-
tion of uncompromising integrity, adventures into the world of
performance excellence or attempts to implement and sustain
improvement programs are futile exercises. ISO 9001 confor-
mity can provide an organization with a foundation of uncom-
promising integrity—a foundation upon which a successful
organization can be built.
Why Should an Organization Want

to Expand Beyond the Minimum
Requirements of ISO 9001:2008?
There are many reasons why an organization should con-
sider expanding processes and performance beyond minimum
requirements. Examples include:
• Escalating customer expectations
• Continual pressure to lower costs and improve efficiency

• Existing and new competition can erode market share

• New technology impacts product design and realization
• Changing product realization and service delivery methods
require active staff development, innovation, and learning
In the contemporary business environment, doing the mini-
mum “just to get by” is likely to lead to the decline and poten-
tial demise of the organization. If an organization does not
continue to improve its products and services, it may become
uncompetitive.
Where and How to Start the Journey

If conformity with ISO 9001 is a requirement, and extension
of processes beyond minimum levels is desirable, how can we
create and deploy a system to accomplish this? Starting the
journey to create or update such a QMS can be a challenge.
One approach to creating a sustainable QMS, explained in
detail below, is to:
• Understand the state of the current system
• Understand the quality management principles that are
the foundation of a QMS
• Create, review, or revise the vision and mission state-
ments of the organization
• Develop, document, deploy, and improve processes con-
sistent with and supportive of the principles, mission,
vision, and objectives of the organization
Understand the State of the Current System

The question of where and how to start the development or
improvement of a QMS depends on the state of the organiza-
tion’s current system. Knowing the state of the current QMS is
the starting point for an improvement journey.

6 Chapter One
At one end of the maturity continuum is an organization

that is just getting by and is engaged in frequent firefighting.
No formal processes are in place to identify, deploy, and track
corrective actions or improvement initiatives. While there may
be improvements over time, those improvements are often not
documented or measured. Because the causes of the improve-
ments are not understood, they cannot be sustained or expanded.
Such an organization may well be falling further and further
behind its best competitors.
Other organizations are different. Activities are completed
to requirements. Corrective action and the continual improve-
ment of products and processes are ingrained behaviors at all
levels. Process performance is measured and tracked. The orga-
nization has processes to evaluate the suitability of the QMS in
terms of its breadth and depth and the level of integration of its
processes. Such organizations have developed mature QMSs
that achieve targeted results and objectives every time.
Understand the Quality Management Principles

One excellent approach for building and deploying a sus-
tainable QMS is to start with an understanding of the qual-
ity management principles (QMPs) that are the foundation of
high-performing QMSs. An organization could invest consid-
erable time attempting to develop a set of internal principles
for its QMS. The authors have conducted research on this issue
and have developed a set of 12 QMPs that any organization can
use as a starting point. These principles are:
1. Focus on customers. Customers are the source of both
the requirements for products and services and the rev-
enues that enable an organization to exist. Focusing on
meeting customers’ needs and expectations is there-
fore essential to organizational survival.
2. Focus on other interested parties (social responsibil-
ity). Owners, employees, other interested parties, and

society at large may all have a stake in the organiza-

tion’s performance. Focusing on the needs of these
other stakeholders is necessary to sustain the organiza-
tion over time.
3. Focus on results. Organizations need to achieve good
results in all key areas of business performance in
order to have a viable future. These include results in
financial performance, customer satisfaction, quality
improvement, environmental performance, and other
key areas.
4. Focus on agility. Being flexible and having rapid
response is critical to organizations faced with chang-
ing external conditions. This goes beyond achiev-
ing operational agility to achieving an organizational
mind-set that embraces rapid change.
5. Focus on the future. Focusing on defining its future
helps an organization to better manage its own destiny.
6. Provide leadership, vision, and purpose. Leaders
establish the purpose of the organization, its objec-
tives, and its vision for the future. Leaders should build
an environment where all members can contribute to
meeting the organization’s objectives.
7. Establish and align objectives. Alignment of objec-
tives in all areas of the organization enhances the abil-
ity to meet goals and achieve results.
8. Manage a system of interrelated processes. Managing
activities and resources together as a process improves
the ability to meet process output needs. Managing the
interactions among the processes as a system enables
the organization to be more effective and efficient at
meeting objectives.

8 Chapter One
9. Manage with facts supported by credible data. Deci-

sions should be made using facts and data tempered
with experience and intuition.
10. Engage in continual improvement, innovation, and
learning. Organizations achieve excellence by learn-
ing, innovating, and improving. It is the people in the
organization who are key to learning, innovation, and
improvement.
11. Commit to the development and involvement of people.
People are the essence of the organization. Their full
engagement in their work and their involvement in
improving it helps the organization meet its objectives.
12. Develop suppliers, partners, and other stakeholders.
Active development of suppliers, partners, and other
stakeholders helps all to create value together.
A detailed description of how we developed these QMPs can
be found in our book Unlocking the Power of Your QMS: Keys
to Business Performance Improvement.1 That book also pro-
vides guidance on how an organization can determine the
importance of each of these principles and perhaps expand the
list to embrace additional ones. Formalizing the principles that
underlie an organization’s QMS is not a trivial exercise, and
it is not one that can be completed by mid-level or frontline
managers. This effort requires thoughtful consideration and
involvement at all levels. It is not easy work and it is often
avoided.
The issue of engaging all levels of the organization, and in
particular top management, in the creation and deployment of
the QMS is very important. Often, practitioners observe that top
management is detached from the quality process. This often is
an accurate observation. Quality professionals should assume
and accept responsibility for the validity of this observation.

So, where do top managers spend their time? In our experi-

ence there are three basic tasks, all of which relate to achieving
and maintaining organizational excellence:
• First, top managers spend a tremendous amount of time
getting investment money to keep the organization’s
doors open. Whether the money comes from banks, ven-
ture capitalists, or other sources, nobody will invest in
your organization unless it has a w
ell-validated product, a
good potential revenue and cash stream, and good leaders
in key jobs.
• Second, top managers work hard to find and retain cus-
tomers. In fact, they often get accused of caring only
about sales and marketing. Why is this? The answer is
simple: survival.
• Third, top managers spend time on people. Finding,
retaining, and motivating employees often becomes a top
manager’s most time-consuming duty.
If the quality professional can find ways to help top managers
accomplish these three things, life will be a lot better. The qual-
ity professional can:
• Implement financial measures of rework, scrap, customer
returns, and all other costs related to internal noncon-
formity and external sources of failure (a financial cost
accounting process)
• Address customer satisfaction issues as opportunities to
improve sales and lower costs (a voice of the customer
process)
• Develop and deploy training for all levels on the financial
rationale for implementing formal corrective action and
preventive action tools for enhancing competence
Notice that the word quality does not appear in any of these
suggested activities. They are all presented as activities that

10 Chapter One
contribute to improving operational excellence. Most CEOs

will spend time listening to cogent arguments for improving
effectiveness and efficiency and enhancing operational excel-
lence. On the other hand, to most leaders, discussions of defect
rates or Six Sigma seem tedious.
Quality professionals must learn to speak the

language of management.
Create, Review, or Revise the Vision

and Mission Statements
The topic of mission and vision statements may bring back
memories of long and tiresome sessions to develop wording
with little meaning. Getting these statements defined, docu-
mented, and understood may be tedious, but this is a funda-
mental prerequisite to be fulfilled prior to attempting to devise
or improve a QMS that is in full alignment with the organiza-
tion’s needs.
When an organization is being developed, the vision and
mission are clear, at least to the person or group of people who
start the organization. They are often written down as a part
of the business plan. As time goes on, the organization grows.
Communication becomes more complex, and the overall busi-
ness purpose and direction is often clouded or lost. Top manag-
ers may still know it, but they may not talk about it very often.
Maintaining a constant, clear understanding of the organi-
zation’s mission and vision is an important prerequisite to the
development of a QMS because full alignment of a QMS with
the needs of an organization requires an understanding of the
basic direction of the organization.
In addition, the basic organizational model must be well
understood. As changes in the external environment occur, top

leaders may need to consider the impact of these changes on

the organization’s mission and vision. This is the “How” asso-
ciated with the mission. It is the answer to questions like: What
is our target market? How do we satisfy customers? What is
our competitive advantage? How will resources be provided?
How will we ensure sufficient cash flow?
Although it is often ignored, the assessment and updating
of the mission, vision, and business plan of the organization—
and ensuring appropriate understanding of these foundational
building blocks by all in the organization—is a requirement on
the journey to develop or improve a QMS.
Mission: What is the purpose of our organization?

Vision: What do we want our business to be like in the future?
Develop, Document, Deploy, and Improve Processes

When the principles of the organization and its mission and
vision have been established, the organization can begin the
task of developing, documenting, deploying, and improving
the processes required to realize its products and services in a
manner that addresses the vision and mission of the organiza-
tion. A very simplified synopsis of how to do this is as follows:
• Identify the processes needed throughout the organization
• Determine the sequence and interaction of these processes
• Determine the criteria and methods needed to ensure
effective operation and control of all processes
• Build in process features that are certain to prevent future
problems
• Monitor, measure, and analyze processes
• Embed corrective action and improvement processes

12 Chapter One
Our book ISO 9001:2008 Explained 2 provides extensive guid-

ance on how to address all the requirements of an ISO 9001–
compliant QMS.
A Few Processes That Deserve

Special Attention
When considering the options for implementing an ISO-
compliant process, many are obvious. In the previous section
we mentioned an approach to getting started. Although many
of the activities that need to be addressed are obvious, a few are
often ignored or receive superficial attention, including:
• Process effectiveness and efficiency
• Continual improvement—both incremental and break-
through
• Change management
These areas require thoughtful attention to ensure the processes
are both effective in achieving the required results and efficient
in terms of resource utilization. Both effectiveness and effi-
ciency are important in order for the QMS to be sustainable.
Process Effectiveness and Efficiency

The difference between effectiveness and efficiency needs to
be understood when considering how to develop and deploy
QMS processes. Effectiveness is defined as the extent to which
planned activities are realized and planned results achieved.
Efficiency is defined as the relationship between the result
achieved and the resources used.
The difference between these definitions is important.
ISO 9001 conformity involves conformity to requirements.
It does not require that conformity be achieved with minimal
investment of human or material resources. If an organization

is managing only to achieve conformity with the standard,

there may be little or no consideration of efficiency. Such an
approach is very undesirable. It is necessary to at least consider
process alternatives that go beyond conformity and achieve
requirements (or better) with minimal investment of resources.
Our belief and recommendation is that in planning pro-
cesses, organizations should first ensure that process outputs
conform to requirements (effectiveness) and then evaluate
how to achieve conforming output with minimal investment of
resources (efficiency).
Effectiveness is the extent to which planned activities are

realized and planned results achieved.
Efficiency is the relationship between the result achieved and
the resources used.
Continual Improvement—
Both Incremental and Breakthrough
The importance of intense attention to deploying processes
to address the principle of continual improvement cannot be
overstressed. Process improvements that result in achieving
conforming output from nonconforming processes or improv-
ing the efficiency of compliant processes can enhance both
organizational performance and customer satisfaction, thereby
contributing to organizational sustainability. Remember, an
organization that is not getting better is getting worse!
An organization that is not getting better is getting worse!
Improvement can occur in many ways. We will address two:

incremental improvement and breakthrough improvement.

14 Chapter One
Table 1.1 C
haracteristics of incremental and breakthrough
improvements.
Incremental Breakthrough
improvement improvement
People People working in the Managers, engineers,

involved process consultants
Size of Small, incremental Big changes

changes changes
Types of Practices, procedures, Technology, new

changes equipment equipment, major
modifications, process upgrades,
elimination/simplification process reengineering
of activities, process
foolproofing
Results Small improvements Large “jumps” in

performance
Cost of Low, generally included High, may involve

projects in operating budget capital investment
Table 1.1 summarizes the characteristics of each approach in

terms of the people who are involved, the nature of the improve-
ments, typical activities to effect the improvements, the results
that can be expected, and the cost to implement the improve-
ment projects. While these generalizations do not apply in all
cases, they do reflect our experience.
Figure 1.2 illustrates the concepts of incremental and
breakthrough improvement in terms of measured performance.
Let’s consider an organization that provides job placement ser-
vices. Suppose that over a five-year period the organization
implemented several incremental improvement projects and
made modest improvements in its job placements. After reach-
ing saturation of the gains that could be made with projects
of modest cost and scope, the organization decided to invest
in a new IT program and hardware to attempt to perform at a

Breakthrough target:
Be 5% better than
Benchmark: benchmark in 18 months
Best-in-class
performance
Incremental
Operating under UP
controlled conditions is Breakthrough
good in 18 months
5 years 18
months
Figure 1.2 Incremental and breakthrough improvement.
higher level than its best competitor. After a period of design

review, capital equipment acquisition, and personnel training,
a breakthrough level of performance was achieved, as shown
in the performance graph. The project took time and finan-
cial resources, but because the measurement system captured
objective evidence of a return on investment (ROI), it could be
demonstrated to management in language that they understood
that the investment was prudent.
Continual improvement is required by ISO 9001, but an
organization should give serious consideration to going beyond
the minimum requirements. Continual improvement can be a
powerful process to enhance both customer satisfaction and
operational excellence, thereby facilitating sustainability.
Change Management
Mergers, acquisitions, s pin-offs, downsizing, outsourcing, and
restructuring are a contemporary reality. ISO 9001 includes
a rather simplistic requirement to maintain the integrity of
the QMS when changes are planned and implemented. This
is much easier said than done. We recommend an aggressive

16 Chapter One
process that incorporates more than reacting after change has

occurred. In Chapter 5 we discuss change related to concepts
such as strategic planning and the impact of globalization on the
QMS of an organization. In terms of conforming to the require-
ments and intent of ISO 9001, an organization can implement
processes that assess the impact of events that could affect the
integrity of the QMS, such as:
• Routine organizational changes
• Implementation of corrective and preventive actions
• Internal and external threats
• Strategic plans for new products and service delivery
processes
• Innovation
• Changes in the mission, vision, and objectives of the
organization
• Changes arising from regulatory, statutory, or compliance
standards
• Output of internal audits, external audits, and self-
assessment
One approach is to require a failure modes and effects analysis
(FMEA) as an element of design review prior to the imple-
mentation of a new process. Such a requirement could be a
cost-effective preventive action.
Summary
We started this chapter with a question: Why should an orga-
nization want to ensure effective conformity with ISO 9001?
In the contemporary marketplace the answer to this question is
clear: Conformity may not be mandatory, but lack of conformity
can be a competitive disadvantage. Further, while conformity

may not be sufficient to ensure sustainability, we believe it is an

essential first step for many organizations. Continual attention
to improvement is required to enhance both customer satisfac-
tion and operating efficiency. Quality management is not some-
thing optional to be done when you find the time. Rather, it is
the work of proper management of the organization.
It is worth repeating that an organization whose perfor-
mance is not getting better is getting worse. It is also worthwhile
to dispel the excuse that working to improve quality manage-
ment is “extra work.” It is not extra work; it is the responsibility
and work of everyone in the organization.
What Can I Do Now?

Actions that can be considered for immediate attention are lim-
ited only by available resources and the ingenuity and creativ-
ity of the professionals in the organization. A few actions to
consider include:
• Review of the mission, vision, and objectives for current
relevance
• Formalization of the organization’s foundational QMPs
• Review of the measurement and reporting processes for
relevance to top management (i.e., whether they are pre-
sented in the language of management)
• Review of the effectiveness of improvement processes,
including preventive action processes
• Review of (or creation of) processes related to managing
change
Such actions will enhance the organization’s ability to conform
to the intent of ISO 9001 and to expand beyond just meeting
the minimum requirements to a level of performance that will
provide a competitive advantage and clear differentiation from
any competition.

18 Chapter One
Notes
ASQ Quality Press, 2004), chapter 1.
Explained, 3rd ed. (Milwaukee, WI: ASQ Quality Press, 2009).

2
Building Your Quality
Management System
M
any organizations that adopt a QMS take a “trust
the people” approach. Portions of the system are
assigned to individuals who become the key players
in the operation of the system. They are often the only people
who understand its secret magic in achieving results. In other
words, these key people have become the system. And, this
works. For a time, there might be gains in quality and massive
cost reductions. The authors have seen organizations exist in
this state for a number of years. But then those key individuals
retire or leave. Or, the team moves on to other activities after
the initial push, the system becomes stale, and top managers
begin to ask, “What has this system stuff done for me lately?”
After a few years, the system withers and dies. What hap-
pened? First, there was really no system at all. Instead, there
were good people with great intentions and a bit of authority
to make things happen. Often in such situations, there was an
inadequate understanding of the process approach. The prac-
tices adopted by the team belonged only to the team and did
not reflect c ross-functional processes that could stand the test
of time.
Why do we continue to make this mistake? Often it is
because we misunderstand the nature of people empowerment.
We tend to prefer giving individuals power over their situation
19
Chapter Two

20 Chapter Two
rather than providing them with process guidance within which

they are free to innovate.
So, if you have not done so by now, become an expert in
process management. While this is not a book on process man-
agement, a short review may prove useful.1
Basics of Process Management

The concept of process management is simple. Its basics are
described in ISO 9001:2008 clause 0.2.2 View the organization
as a collection of interrelated processes all sharing the purpose
of achieving the organization’s objectives. At the simplest level,
all of the work of the organization occurs as part of a process.
A process is defined in ISO 9000:2005 as a “set of interrelated
or interacting activities which transforms inputs into outputs.”
Figure 2.1 illustrates this simple concept. Processes must be
supported with resources. A person or a group of people can
conduct each process activity. Sometimes, whole departments
are established to do a single activity. The people who work
within the process use resources to make the transformation
possible. These resources may include:
• Equipment such as production equipment, telephones,
computers, robots, and transportation equipment
• Data and information, and software to manipulate the
data and information
• Workspace and associated support items such as air con-
ditioning units, desks, and tables
Activity Activity Activity

Input Output
Figure 2.1 P rocess: A set of interrelated or interacting activities that

transform inputs into outputs.

Building Your Quality Management System 21
Processes are also supported by a variety of human, mechani-

cal, and electronic controls. Some examples of control mecha-
nisms include:
• Normal day-to-day supervision
• Automated control systems that adjust the process when
it drifts from established values
• Inspection or peer review of work using criteria that have
been established in the context of customer needs
• Foolproofing devices to prevent the process from pro-
ducing items that do not meet established rules or
requirements
Resources and controls can be viewed as supporting the pro-
cess as illustrated in Figure 2.2.
Manage the System

The process concept is a simple one. If your organization has a
single key process (and some organizations do), process man-
agement will be simple. But most organizations have a number
of key processes (that sometimes interact) as well as supporting
processes without which the key processes could not operate.
Controls
Activity Activity Activity

Input Output
Resources
Figure 2.2 Processes are supported by resources and controls.

22 Chapter Two
The processes of an organization’s system are more than

just those required to meet the minimum requirements of ISO
9001. A more holistic view of an organization’s processes
might look like Figure 2.3.
These processes interact with one another to form a sys-
tem. Organizations should strive to develop a system so that
it becomes more effective and efficient in meeting the needs
of customers and achieving the organization’s objectives. Fig-
ure 2.4 illustrates the concept of a system of interrelated pro-
cesses, improved over time and driven by top managers, with
a focus on meeting objectives and satisfying customer needs.
Many organizations expend significant resources on activi-
ties such as flowcharting and get little real benefit. Often this
is because they have not addressed the true meaning of process
management. An understanding of process management begins
with an enigmatic dichotomy—a problem that seems intrac-
table and has components that seem to be mutually exclusive.
There appears to be an enigma in that the problem of getting
benefits seems insolvable. The problem seems hard to solve
because it is a dichotomy:
• To benefit from the process management concept, we
must first understand the organization’s key drivers of
performance
• To understand the key drivers of performance, we must
understand the key processes
This situation is made more complex because understanding
how results are achieved also requires us to understand the
interactions between the processes.
Processes Needed to Conform to ISO 9001:2008

Since ISO 9001:2008 has five key clauses that contain require-
ments, it is a simple matter to outline the processes needed to
achieve conformity. First, clause 4 has the requirements for

Inputs/resources Organization Outputs (results) Interested parties

with their qualities, costs, with their qualities, costs, with their needs, expectations,
H1446_Cianfrani_pi_000.indd 23
and delivery times and delivery times and requirements
Supplies Confidence Customers, society, owners

(purchased products)
Offered products Customers
Human resources With its
management
Facilities
system
Work environment implementing ISO 9001 focus
Technology resources the various policies
and objectives by Effects on people Customers, owners, society, employees
Information resources and environment
appropriate
Natural resources network
of processes,
Energy Wastes, emissions Society, customers, owners
structure, etc.
Financial results Owners, employees, suppliers
Financial resources
Growth Owners, employees
Other
Effects on employees Employees, owners, customers, society
Information Owners
Others ...
Adjustments
Figure 2.3 An organization’s process model.

Building Your Quality Management System
Source: Reproduced from C. A. Cianfrani, J. J. Tsiakals, and J. West, The ASQ ISO 9000:2000 Handbook (Milwaukee, WI:
23
ASQ Quality Press, 2002), Figure 3.1.
11/2/13 11:43 AM
24 Chapter Two
Driven by top management
Continually improving effectiveness
Process Process
Focused Objectives Customers
Process Process Process
Figure 2.4 A family of well-managed processes.
identification and management of system processes. Then

clauses 5–8 describe the processes needed.
The basic concepts are simple and the requirements can be
expressed as follows:
• Management responsibility—processes related to the
development and management of the QMS. Clause 5
requires processes for management commitment, plan-
ning the system, establishing objectives, and reviewing
results.3
• Resource management—processes related to the man-
agement of human and other resources. Clause 6 requires
processes to ensure continual provision of adequate
resources. It also requires certain supporting processes
to ensure personnel competence and an adequate work
environment.4
• Product realization—processes related to the design,
production, and delivery of products and services.5 These
include applicable processes for purchasing,6 process
validation,7 and outsourcing. ISO 9001:2008 is very flex-
ible in this area, clause 1.2 even allowing organizations
to exclude some product realization processes included in
clause 7 (but only those in clause 7) if they do not apply.8

• Measurement, analysis, and improvement—processes

needed to measure products, processes, and customer
perceptions to ensure conformity to customer require-
ments and to provide a basis for analyzing data to develop
improvements in the processes, the system, and, where
needed, the products.9
Processes Derived from Excellence Models

Excellence models such as the Malcolm Baldrige National
Quality Award in the United States and the European Founda-
tion for Quality Management criteria in Europe add the notions
of strategic planning and a focus on achieving results. An advan-
tage of these models is that they are reviewed and updated as
needed every few years. An important concept that appears to
be unique to the excellence models is the notion that the sys-
tem needs to be agile. Agility is a systematic ability that enables
an organization to react quickly to external changes, even to
the point of being able to predict such changes and take action
before the impact is felt by competitors or customers.
Examples of other processes or organizational characteris-
tics included in excellence models that should be considered for
deployment in a contemporary QMS beyond a focus on strate-
gic planning, measuring, tracking results, and agility include:
• Employee involvement
• Ethics
• Tool selection (e.g., Six Sigma, lean, balanced scorecard)
• Transparency
• Flexibility
• Building sustainability into business drivers
• Explicit linkage of processes to results

26 Chapter Two
• Work–life balance
• Natural resources
Excellence models also emphasize results achieved in areas
such as customers, people, society, and strategic key indicators.
Processes from ISO 9004:2009

ISO 9004:2009 was developed with the notion that the QMS
can be a facilitator of an organization’s sustained success over
time. It includes some of the additional processes of the excel-
lence models and provides its own guide for users to self-assess
their QMS. Examples of processes recommended to enhance
achieving sustained success beyond those required by 9001
include:
• Risks associated with natural resource availability
• Expansion of data collection and analysis
• Formalization of innovation
• Formalization of learning
Figure 1 of ISO 9004:2009, reproduced here as Figure 2.5, pro-
vides a model that aligns these broader concepts of strategy and
sustainable success, along with their attendant processes, with
the model in ISO 9001:2008.
Other Observations
Future of Quality studies conducted by the American Society
for Quality (ASQ) and the last several Conference Board CEO
Challenge studies offer some insight into additional process
needs for organizations to consider (see Chapter 6). Pertinent
issues include:
• Globalization. We all know that innovation, commerce,
marketing, sales, and staffing are global issues for many,

Continual improvement of the quality management

Organization’s Organization’s
system leading to sustained success
environment environment
Interested ISO 9004 Interested
parties Clause 4 parties
Managing for the
ISO 9004 sustained success of ISO 9004
Needs Clause 5 an organization Clause 9
and Strategy and Improvement,
expectations policy ISO 9001 innovation,
Clause 5 and learning
Management
responsibility
ISO 9001 ISO 9004

ISO 9004 ISO 9001 Satisfaction
Clause 8 Clause 8
Clause 6 Clause 6
Measurement, Monitoring,
Resource Resource ISO 9001
analysis and measurement,
management management
improvement analysis and
(extended)
Customers review Customers
Needs ISO 9001

and Clause 7
Product
expectations Product
realization
ISO 9004
ISO 9004
Clause 7
Process
management
Key
Value-adding activities
Foundation: Quality management principles (ISO 9000)
Building Your Quality Management System
Information flow
27
Figure 2.5 Process relationship of ISO 9001:2008 to ISO 9004:2009.

Source: ANSI/ISO/ASQ Q9004-2009.
11/2/13 11:43 AM
28 Chapter Two
if not most, organizations today. This means that quality

has gone global. Systems and processes now have to be
capable of performing as intended in any culture at any
time. Many organizations have enough trouble control-
ling dynamic processes in their own backyard much less
across the globe. But smart organizations are learning how
to manage global quality processes in this dynamic age.
• Social responsibility is becoming a market expectation.
In the past, social responsibility was relegated to the list
of obscure buzzwords understood by few except its advo-
cates. This has changed. The concept spans governance,
human rights, labor practices, fair operating practices,
process and personnel safety, environment, consumer
interests, and contribution to society. For a more com-
plete discussion of this topic, see ISO 26000:2010, Guid-
ance on social responsibility.
• Workforce competence issues may well outpace the issue
of unemployment as workforce skills are diluted by the
retirement of baby boomers and a greater need for work-
ers with technical competence. This need may be acute
when high knowledge and experience are required (e.g.,
for Six Sigma Black Belts and Master Black Belts) to
guide the solving of ever more complex problems. Orga-
nizations of all sizes are engaged in developing advanced
mechanisms for education, training, and testing.
• Integrating management systems has become a necessity.
While most of the certified management systems in the
world are certified to some version of ISO 9001 or sec-
tor versions thereof, a growing number of organizations
are finding it necessary or beneficial to also achieve con-
formity to other management system standards, such as
ISO 14001:2004, Environmental management systems—
Requirements with guidance for use. Integrating the sys-
tems used for conformity to multiple ISO management

system requirements is not difficult and should be consid-

ered by any new user. The ISO management system stan-
dards are designed to be used together with relative ease.
• Consumer awareness is about consumers using their
knowledge to make purchasing decisions best aligned
with their preferences. Before the internet, information
about product quality was limited. Today, consumers can
shop around the world, and they base their decisions on
information obtained from the internet—not just related
to the product or service itself, but also related to the
practices of the company. The internet, excellent search
engines, and social media provide everyone with instant
access to information. Consumer behavior often moves at
a dizzying pace. And it is not all positive. Even rare nega-
tive events get reported. Reputations can be destroyed
or embellished in hours or even minutes. Organizations
are finding it necessary to have processes in place to deal
with these situations.
• Innovation is no longer just a buzzword. In fact, it has
become an imperative. A few years ago most of us did not
understand what the word implied. Today organizations
need to have disciplined processes to facilitate the devel-
opment of innovative products and services. Invention is
still important, but it is the transformation of an idea into
a saleable product that constitutes real innovation. New
methods may be needed by organizations to validate their
innovative products against potential consumer needs.
Often the customer does not even know the possibilities a
new product can bring.
Summary
This chapter has explored the basics of process management as
a fundamental for developing and maintaining a QMS. It also

30 Chapter Two
has discussed the various additional processes that should be

considered in developing the QMS, both to ensure conformity
with ISO 9001 requirements and to go beyond these require-
ments to ensure that the QMS is a vital contributor to organiza-
tional sustainability.
What Can I Do Now?

There are a large number of processes that can be developed as
the management system matures. But which ones are important
for your organization? For most organizations, the answer to
that question can be found through self-assessment. You can
use any number of tools to accomplish this. The next chapter
and Chapter 5 will review this subject in detail.
Notes
1. For more on this topic, see J. West and C. A. Cianfrani, Unlock-
ing the Power of Your QMS: Keys to Business Performance
Improvement (Milwaukee, WI: ASQ Quality Press, 2004).
Explained, 3rd ed. (Milwaukee, WI: ASQ Quality Press, 2009),
5–7.
3. Ibid., 40–63.
4. Ibid., 66–81.
5. Ibid., 84–154.
6. Ibid., 122–130.
7. Ibid., 139–142.
8. Ibid., 12–13.
9. Ibid., 156–212.

3
Why Is Quality Auditing
Important?
T
here are several different types of management system
audits. Examples include quality, financial, environ-
mental, information system, and sector-specific audits
(e.g., automotive, aerospace, telecommunications, medical
devices). This chapter addresses auditing related to QMSs.
There are three basic audit categories:
• First-party audits: internal audits an organization per-
forms on its own system
• Second-party audits: audits that customers perform on
their suppliers
• Third-party audits: audits performed by registrars or other
interested parties such as regulators
One reason QMS auditing is important is that it is a require-
ment of ISO 9001 (clause 8.2.2). It also impacts the ability of
the organization to operate in conformity with many of its prin-
ciples and core values. Even if auditing were not an ISO 9001
requirement, having an effective audit process would make
sense. Auditing provides confidence that processes and con-
trols are being implemented in accordance with all organiza-
tional and regulatory requirements as applicable. No reputable
organization would believe it could operate without periodic
financial controls and audits of its processes. Why shouldn’t a
31
Chapter Three

32 Chapter Three
reputable organization have the same belief about quality con-

trols and audits?
Auditing is not just a valuable tool of quality control; it
is also crucial to quality improvement. Often improvement
projects yield changes that are well managed in the short term.
Over time, the organization tends to slip back into its old, bad
habits and the improvement gains are lost. Audits can be a criti-
cal tool to ensure the organization holds the important gains.
For example, capital projects should be audited to ensure they
achieve technical and financial objectives.
In addition to providing confidence that processes continue
to perform as intended, auditing provides evidence of prudent
judgment in case issues of liability ever arise related to the
organization’s products.
Auditing is also a useful tool to ensure the effectiveness of
outsourced or offshore-produced products and processes that
are often neglected (“out of sight, out of mind”).
Auditing is a valuable source of input for the corrective
action, preventive action, and continual improvement processes
of an organization. When auditing results are used in conjunc-
tion with management review and corrective action, an orga-
nization will improve its internal effectiveness and efficiency,
increase its customer satisfaction, and enhance its sustainabil-
ity prospects.
In summary, we deploy a quality audit process for many
reasons, including the following:
• To ensure compliance with ISO 9001
• To ensure compliance with organization requirements (an
ISO 9001 requirement)
• To ensure compliance with regulatory requirements (an
• To ensure the implementation and maintenance of QMS
effectiveness (an ISO 9001 requirement)

Why Is Quality Auditing Important? 33
• To seek opportunities for improvement (not an explicit

• To uncover best practices that could be applied in other
areas (not an ISO 9001 requirement)
• To provide input into the corrective action, preventive
action, and continual improvement processes (an ISO
9001 requirement)
• To ensure the maintenance of improvement for processes
where corrective action has been implemented (not an
• To provide objective evidence of the organization’s pru-
dent judgment if issues of liability were to ever arise (not
an ISO 9001 requirement)
The Basics—A Summary

This chapter will not address the details of auditing but rather
will focus on ensuring that minimum requirements are addressed
and why doing just the minimum to meet ISO requirements
would be a disservice to the organization.
Auditing is a process in which an objective and impartial
evaluation is made of all or part of a QMS’s implementation
against a greed-upon criteria (see ISO 9001:2008 clause 8.2.2
for explicit requirements). The formal definition of auditing is
“a systematic, independent and documented process for obtain-
ing audit evidence and evaluating it objectively to determine
the extent to which audit criteria are fulfilled.”1
Internal quality audits are used by and for an organization
to evaluate (1) the adequacy of the implementation of its QMS,
(2) whether requirements are being met, and (3) the effective-
ness of system implementation. Audits can also be used to
identify recommendations for corrective actions, preventive
actions, best practices, and opportunities for improvement.

34 Chapter Three
Internal audits are conducted by, or on behalf of, an organiza-

tion for internal purposes and can form the basis for the organi-
zation’s self-declaration of conformity of its processes to specific
requirements. Supplier audits are conducted by customers of the
organization, or by other persons on behalf of a customer, to
ensure compliance with customer requirements. Registration
and regulatory compliance audits are conducted by external
organizations outside of the typical customer–supplier relation-
ship. All of these audits can verify whether requirements, such
as those of ISO 9001 or a customer, are being met.
In addition to the QMPs described in Chapter 1, there are
principles that need to be understood, embraced, and observed
by those who conduct audits. Those principles are:
• Ethical conduct
• Fair presentation
• Professional care
• Independence
• Objectivity
• Impartiality
• Evaluations based on evidence
• Competence
• Cooperation
• Trust
A further discussion of principles can be found in our book
How to Audit the P rocess-Based QMS 2 and in ISO 19011.
Once competent auditors are identified, the actual audit pro-
cess can be summarized as consisting of three stages: (1) pre-
paring for an audit, (2) conducting an audit, and (3) reporting
the results of an audit (see Figure 3.1).

Report
Prepare Conduct
the results
for the audit the audit
of the audit
Figure 3.1 The audit process.
Each of these stages should have a procedure or work

instruction that provides details on how to complete the many
activities that need to be consistently addressed during that
stage. For example, for the second stage, conducting the audit,
an organization could have a flowchart (see Figure 3.2 for an
example) or work instructions or procedures or a combination
of both, as appropriate, for the required activities.
The many details of planning, conducting, and reporting
the results of an audit can be found in our book How to Audit
the Process-Based QMS. That book also contains tools, check-
lists, and sample audit questions to assist in creating a new
audit process or improving an existing one.
Interview
people
Form
conclusions
Conduct
Observe Analyze
opening
activities data
meeting
Conduct
closing
meeting
Examine
records
Figure 3.2 Conducting the audit.

36 Chapter Three
The Distinction between

Audit, Self‑Assessment,
and Management Review
Management review is a process that assesses the suitability,
adequacy, effectiveness, and efficiency of the QMS (ISO 9001
clause 5.6). It is typical for top managers to use management
review and audit processes to identify and prioritize improve-
ment initiatives. Both management review and audit are pro-
cesses required by ISO 9001.
There is a third process used by organizations to identify
areas that require corrective action or whose effectiveness
and efficiency could be improved beyond meeting minimum
requirements. This process is s elf-assessment.
Self-assessment is an evaluation of the effectiveness and
efficiency of the organization and the maturity of the QMS. It
results in a perception and judgment regarding:
• Conformity of processes to requirements
• The maturity level of the QMS processes that will con-
tribute to sustained success
• Opportunities for improvement and innovation
• Priorities for improvement
• Identification of best practices and processes that
have potential for implementation in other areas of the
organization
• Action plans that could be considered to improve product
and process efficiency and effectiveness
Self-assessment is performed by or at the direction of the orga-
nization’s management. The intent of self-assessment is to pro-
vide fact-based guidance to the organization regarding where
to invest time and resources for improvement. It also can be

useful in measuring progress against objectives and in assess-

ing the continuing relevance of defined objectives.
Self-assessment is different from audit because it goes
beyond determining conformity with detailed requirements. It
is structured to identify opportunities to improve efficiency and
performance and to evaluate the maturity of process design and
deployment. To guide a self-assessment endeavor, organiza-
tions often use ISO 9004:2000, ISO 9004:2009, the USA Tech-
nical Advisory Group to ISO TC 176 document titled Technical
Report—Guidelines for Performing a Self- Assessment of a
Quality Management System, or excellence models such as
the Criteria for the Baldrige Performance Excellence Program.
The output from a s elf-assessment can be an overall view of the
performance of the organization and the degree of maturity of
the QMS. It can also identify areas requiring improvement in
the organization and guide the assignment of priorities. A com-
mon scoring approach is to use five levels of maturity when
evaluating processes or systems included in the assessment
scope, ranging from 1 (no formal system) to 5 (best-in-class
performance).
For details on self-assessment, a good starting point is
to review the content of ISO 9004:2009 clause 8.3.4 and
Annex A—Self-Assessment Tool. As mentioned above, the
USA Technical Advisory Group to ISO TC 176 has published
a document titled Technical Report—Guidelines for Perform-
ing a Self-Assessment of a Quality Management System. This
report is available from ASQ (ASQ Z1 TR1-2012).
Self-assessment is not an ISO 9001 requirement. It can pro-
vide management with a different and more fertile evaluation
of conformity of processes to requirements, and it can provide
insight into the maturity of processes and their implementation.
One of the most valuable outputs of s elf-assessment is the iden-
tification of disconnects among the vision, mission, business
model, and principles of an organization.

38 Chapter Three
Self-assessment is not a substitute for internal audit and

is not intended to conflict or compete with the use of exist-
ing quality award or excellence models. It is a tool that can
enhance the identification of improvement opportunities and
the setting of priorities for the allocation of the limited human
and capital resources of an organization. It is a tool that every
organization should consider implementing in addition to the
audit process required by ISO 9001.
What Are the Minimum

Requirements for Auditing?
The specific minimum requirements of ISO 9001:2008 for
auditing are contained in ISO 9001 clause 8.2.2. In summary,
these requirements include:
• Plan an audit program
• Document responsibilities and requirements in a proce-
dure
• Audit at planned intervals
• Define the audit criteria, scope, frequency, and methods
to be used
• Ensure the QMS conforms to planned arrangements
• Ensure the QMS is effectively implemented and main-
tained
• Ensure the competence, objectivity, and impartiality of
auditors
• Report results
• Ensure that corrective action for problems and nonconfor-
mities is considered and, where appropriate, taken—all

in a manner that is in alignment with organizational

objectives
• Follow up to verify actions taken and reporting of verifi-
cation results
Our books How to Audit the P rocess-Based QMS and ISO
9001:2008 Explained 3 describe in detail how to address the
establishment and deployment of processes to meet these
requirements.
A visual representation of internal audit inputs and outputs,
the resources required, and the role of management in the pro-
cess can be seen in Figure 3.3.
• Provide resources
• Review results
• Use results
Management
Input Internal audit Output
• Policy • Audit report

• History • Findings/corrective
Resources
• Documents action requests

• Customer feedback • Follow-up
• Planning • Improvement
• Conclusions
• Information
• Time
• Trained personnel
Figure 3.3 A
udit inputs and outputs, resources required, and
management role.

40 Chapter Three
Tips on How to Pass an

ISO 9001:2008 Certification Audit
What does an organization need to do at a minimum to ensure
a successful outcome of a certification audit by a registrar? The
answer involves two activities:
1. Ensure that all processes required by ISO 9001:2008
are established and deployed and that objective evi-
dence exists to demonstrate compliance
2. Have an efficient, effective internal audit program to
make sure the system is always in place
To provide a brief overview of what this means, let us consider
at a high level the primary areas of interest to outside auditors
and what an organization should do to be prepared. The pri-
mary areas of interest are:
• Scope, objectives, and documentation of QMS.
• All QMS processes. An outside auditor will sample pro-
cesses that fall within the scope of the QMS for objective
evidence of conformity for any (or all) of the following
process characteristics as appropriate:
——Inputs
——Activities
——Outputs
——Documents
——Records
——Data analysis
——Corrective actions
——Preventive actions
——Housekeeping

——Improvement
——Feedback loops
——Results
The organization can emulate an outside audit by performing an
internal audit of all processes of the QMS to ensure compliance
with internal requirements as well as ISO 9001 requirements,
with particular attention to the above process characteristics
and implementing appropriate corrective action where noncon-
formity is evident.
For details on the kinds of questions to ask during such an
internal audit, see our book titled ISO 9001:2008 Explained.
For every clause and subclause of ISO 9001:2008 there is an
explanation of what the requirement is, what it means, tips on
implementation of compliant processes, considerations for
documentation, and questions to ask to assess conformity.
Going Beyond the Minimum?

Diligent pursuit of continual improvement activities driven
by an auditing process mandated by ISO 9001 will impact the
effectiveness but not the efficiency of the QMS. To achieve
operating excellence, additional activities should be consid-
ered beyond the required activities. To get started, the follow-
ing activities can be considered for deployment to expand the
scope and depth of the audit process beyond the minimum
requirements of ISO 9001:
• Audit to identify opportunities for improvement
• Audit to identify best practices that can be deployed in
other areas of the organization
• Implement a self-
assessment process to characterize
QMS maturity

42 Chapter Three
• Audit against applicable requirements defined in

sector-specific standards and regulatory-based stan-
dards that are not included in ISO 9001 (e.g., control of
the development of new or improved processes per the
requirements of clause 7.3 for new products)
• Audit to identify preventive action opportunities in addi-
tion to identifying nonconformity
• Formalize processes to verify corrective action effective-
ness
• Quantify, where practical, the cost of identified noncon-
formities or opportunities for improvement in financial
terms (i.e., money)
• Expand the education of auditors and auditees on the
purpose and objectives of audits; include topics such as
customer satisfaction, improved performance, and job
retention, not just finding deviations from requirements
• Formalize corrective action follow-up to ensure align-
ment of corrective action work with objectives, and
ensure timely and effective completion (e.g., maintain a
corrective action log and a reporting process, review for
relevance of each improvement project)
• Incorporate and integrate quality audits with other audits
conducted by the organization, such as audits of environ-
mental systems (ISO 14001)
• Formulate a generalized audit process that addresses all
management system audits to minimize audit duplication
Most of these activities are familiar to quality practitioners,
but a few merit elaboration, in particular the auditing of con-
formance to the content of sector-specific standards and the
quantification of the cost of nonconformity or opportunities for
improvement in financial terms.

First consider sector-specific standards that incorporate

references to auditing. A representative listing of standards
meriting review and consideration includes:
• AS9100C—Aerospace
• ISO/TS 16949 (five subclauses)—Automotive
• ISO 14001 (including annex A)—Environment
• OHSAS 18001—Health and Safety
• ISO 13485—Medical Devices
• ISO 20000-1—Information Technology—Service Man-
agement
• ISO 27001—Information Technology—Information Secu-
rity
• ISO/TS 29001—Petroleum, Petrochemical, and Natural
Gas
• ISO 9004 (clause 8.3)—Quality Management for Sus-
tained Success
All of these standards include guidance or requirements related
to auditing that expand the scope of auditing beyond what is
required by ISO 9001. It is worth reviewing these standards
to determine if any of the additional guidance or requirements
would improve the capability of your organization to achieve
performance excellence.
Most quality professionals have an abstract understanding
of the quantification of the cost of nonconformity or opportuni-
ties for improvement in financial terms. In actual practice these
concepts are often applied in an informal and inconsistent man-
ner. Often they are not practiced at all. In order to communicate
with management in terms that will motivate a commitment of
resources to corrective actions, preventive actions, or process
improvements, it is desirable to quantify recommendations in

44 Chapter Three
financial terms (i.e., money) since the language of manage-

ment is money. Revenue, costs, and profit and loss are terms
that senior executives relate to—not defect rates. The use of
financial language is not mandated by ISO 9001, but if quality
professionals wish to drive improvement, we must learn to use
the language of management to communicate the need for
corrective action or process improvement. One approach that
has proven effective, though its use is not common, is to deploy
a Cost of Quality process.4 Implementing such a measurement
process throughout the organization is recommended, but even
a limited implementation related to audit findings and obser-
vations can have a profound impact. The audit process, for
example, could require the identification of direct and obvious
costs related to not meeting requirements as well as the hidden
costs related to nonconformity. Such cost information could be
included as an annex in audit reports.
Developing a comprehensive Cost of Quality process is a
daunting task, which is why it is so often ignored. On the other
hand, there are simple techniques that can be adopted. Imple-
menting a limited version for reporting audit results and rec-
ommendations may be a useful way to get started.
The Cost of Quality concept is not new; it is just underuti-
lized as an element of many QMSs. Veteran quality profession-
als will recall that Cost of Quality was a requirement embodied
in Mil Q 9858A starting in the early 1960s.
Summary
It is vital that organizations embrace QMS auditing as a pow-
erful tool to ensure the understanding, deployment, control,
measurement, and improvement of processes. Auditing pro-
vides confidence to the organization and its customers that its
processes and controls are being implemented in accordance
with all organizational and regulatory requirements and that

requirements are being met. An ancillary benefit of a robust

audit process is that it could provide evidence of prudent judg-
ment if issues of liability were ever to arise related to the orga-
nization’s products.
The quality auditing process can also provide valuable
input to the management review process, guiding the establish-
ment of priorities for improvement projects to correct detected
nonconformities and alerting management to any disconnects
observed that relate to QMS effectiveness or to the comprehen-
sion of the organization’s vision, mission, and objectives.
A robust audit program is important, but it is only one
aspect of the QMS. No organization should try to use audits to
bring itself into conformity with ISO 9001! The essentials of
achieving such conformity also include careful process man-
agement and a culture that encourages improvement.
What Can I Do Now?

To strengthen and expand an audit process, several actions can
be considered. We suggest the following:
• Review existing processes to ensure compliance with the
minimum requirements of ISO 9001
• Select a few of the existing processes in your QMS for
major improvement
• Prioritize processes to be considered—this can be guided
by a review of customer complaint records, quality cost
data related to internal costs of nonconformity, operator
feedback, prior audit reports, review of the corrective
action log, and review of the inventory of potential pro-
cess improvement projects
• Use financial justification to facilitate the approval of, and
enthusiasm for, initiating innovative projects to expand
the breadth and depth of the QMS

46 Chapter Three
Notes
1. ISO 9000:2005 Quality management systems—Fundamentals
and vocabulary; ISO 19011:2011 Guidelines for auditing man-
agement systems.
2. D. R. Arter, C. A. Cianfrani, and J. West, How to Audit the
Process-Based QMS, 2nd ed. (Milwaukee, WI: ASQ Quality
Press, 2012).
Explained, 3rd ed. (Milwaukee, WI: ASQ Quality Press, 2009),
5–7.
4. A full discussion of the Cost of Quality concept is beyond the
scope of this book, but a number of other books provide a good
starting point, particularly D. C. Wood, ed., Principles of Qual-
ity Costs: Financial Measures for Strategic Implementation of
Quality Management, 4th ed. (Milwaukee, WI: ASQ Quality
Press, 2013).

4
What Is Needed to
Be Successful
I
n this chapter we identify some of the ISO 9001:2008
requirements that are necessary but often are not done
well, and we offer suggestions for improvement in those
areas. We also recommend certain system elements that are not
required by ISO 9001:2008 but that may be critical to success
in many organizations. You need to think about these things
and exercise all this against your own principles, mission,
vision, objectives, and situation. Chapter 5 will provide guid-
ance on how to select system elements to add or improve. Used
together, Chapters 4 and 5 can help you determine which ele-
ments to attack and in what order.
Addressing Effectiveness
(Capability and Capacity) and
Efficiency (Waste Elimination)
In Chapter 1 we discussed the distinction between process
effectiveness and process efficiency, making the point that we
should strive for both. In the narrowest of senses effective-
ness is meeting the requirements, but true effectiveness can be
thought of as effectiveness on steroids. To sustain effectiveness
we must be capable of meeting requirements, but we must also
have the capacity to meet requirements over time and when
demand for our product changes.
47
Chapter Four
H1446_Cianfrani_pi_000.indd 47 11/2/13 12:31 PM

48 Chapter Four
There are also several ways to look at efficiency that can be

considered effectiveness with minimal use of resources.
Addressing Competence: Embedding

Learning as a Formal Process
The competence requirements of ISO 9001 tend to focus on the
common human resources (HR) processes related to people.
Competence encompasses a variety of types of learning. Learn-
ing needs to be driven by the people and functions that are
important to sustainability to ensure learnings are institutional-
ized. It needs to be taken out of the hands of the HR specialists
and put in the hands of people within the various functional
areas of the organization. Organizational processes should be
developed to address the maintenance of competence. It is
normal for these processes to differ from function to function.
The development of these processes may require investment in
human and other resources, so capital investment must be well
planned and included in resource plans. It needs to be treated
in the same way as the capital cycle for machinery, plant, and
equipment. For example, in manufacturing, industry is moving
from a man-machine interface to a m achine-to-machine inter-
face. How will this trend impact your organization? Another
trend impacting all organizations is that the internet is driving
rapid changes to today’s marketing practices. We need to learn
to use the internet to our organization’s advantage. We need to
understand how we will manage marketing in a new world. We
need to be able to project what will be available in a few years.
Knowledge and its relationship to organizational compe-
tence is a broad area of opportunity. We need to find ways to
manage knowledge. This is a very abstract and difficult topic.
Priority needs to be placed on understanding what we do today,
what we will need to do in the future, and how to move from
where we are to where we need to be. We need to recognize that

What Is Needed to Be Successful 49
much of what is known in an organization is tacit knowledge—

knowledge that is expressed or activities that are carried out
without words or speech and are difficult to transfer to another
person. That reality is both good and bad, because while the
knowledge in people’s heads has great value to the organiza-
tion, it is very difficult to transfer this knowledge among peo-
ple, much less between people and machines. Organizations
need to learn how to build a stable platform of knowledge to
understand old ways, new ways, and change processes. You
might think of it as a three-legged stool with a bottle of wine
on top: Ultimate care is needed to make certain not a drop of
wine is spilled. There are many opportunities here to enhance
performance. The real challenge is to do these things without
wasting time.
Product and Process Validation

During the late 1980s and into the 1990s, users of ISO QMS
standards often defaulted to the old ISO 9002 standard so they
would not have to deal with ISO 9001 requirements relating
to control of product design. Even today, organizations new
to the standard have a tendency to resist including design con-
trols in their formal QMS. There are some good reasons for this
reluctance.
There is, of course, a concern that applying the formal
design review, verification, and validation requirements of ISO
9001 clause 7.3 might lead to excessive controls in development
efforts, which could generate “unwarranted” costs. There is also
a concern about “folks looking over the designer’s shoulder.”
Perhaps most important, there may be a perception that extra
time would be necessary to analyze and understand the benefits
of good design controls as a means of managing risk. In other
words, for designers, the potential drawbacks of exercising con-
trols may be perceived to outweigh the potential benefits.

50 Chapter Four
On the other hand, most recognize that many manufactur-

ing and service delivery problems have their roots in design
and development processes. So do many problems that relate
to the marketplace failing to accept new products. Perhaps the
key is to implement clause 7.3 on design and development in
a manner that will contribute to designers’ creativity, reduce
costs, and ensure that customers’ needs are met.
ISO 9001 clause 5.3 requires that the quality policy also
include commitments to meeting requirements and the contin-
ual improvement of the QMS. Clause 7 on product realization
requires the identification of customer requirements; clause 7.3
requires that product designs be validated to ensure they will
meet requirements for given applications, and that the product
be verified to ensure that requirements are met. Excerpts of
the overall requirements of clauses 7.2 and 7.3 are provided in
Figure 4.1.
One approach is to ensure there is a clear understanding
of the requirements for design control and how they relate
to issues such as achieving the organization’s design goals,
maintaining creativity, and meeting cost objectives. Start by
explaining the required controls to the design team and get
them to list the problems and issues they see in implementing
those controls. Then address each issue during the design and
development planning process. Focus on defining areas where
creative thinking will be necessary to achieve design objec-
tives and meet customer needs. The overall product design and
development process is shown in Figure 4.2. The only part of
the diagram that is not affected by clause 7.3 is the box related
to risk analysis and preventive action, which is addressed by
clause 8.5.3.
During product design it is important to determine how
to use design review, verification, and validation as input for

7.2.1 Determination of requirements related to the product

The organization shall determine
a) requirements specified by the customer, including the requirements for
delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or
intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organization.
7.3.1 Design and development planning
The organization shall plan and control the design and development of product.
Required activities include determining
a) design and development stages
b) review, verification and validation activities appropriate for each design and
development stage
c) responsibilities and authorities for design and development
It is also required that interfaces be managed to ensure effective communication.
7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined. . . . These inputs shall
include . . .
a) functional and performance requirements
7.3.4 Design and development review
Systematic reviews of design and development shall be performed
a) to evaluate the ability of the results of design and development to meet
requirements, and
b) to identify any problems and propose necessary actions
7.3.5 Design and development verification
Verification shall be performed to ensure that the design and development outputs
have met the design and development input requirements and records shall be
maintained.
7.3.6 Design and development validation
Design and development validation shall be performed to ensure that the resulting
product is capable of meeting the requirements for the specified application or
intended use, where known.
7.3.7 Control of design and development changes
Design and development changes shall be identified and records maintained. The
changes shall be reviewed, verified and validated, as appropriate, and approved
before implementation.
Figure 4.1 V
alidation that product designs meet customer
requirements—summary of requirements.
Source: ANSI/ISO/ASQ (E) Q9001-2008.

52 Chapter Four
Design and development planning
Design verification
Design
Customer Design process Design
Product
needs inputs phases and outputs
reviews
Risk analysis and preventive action
Design validation
Figure 4.2 Design controls illustrated.
risk analysis and the development of preventive actions. For

example:
• Design review. In most cases, design review is conducted
at various stages during the design process; it is one way
to address issues such as product dependability and ser-
vice reliability related to the product. It is critical to con-
sider the importance of all the “-abilities” related to the
product in design review—manufacturability, deliver-
ability, testability, inspectability, shipability, serviceabil-
ity, repairability, availability, reliability, etc.—as well as
issues related to inventory and production planning and
the purchase of components and subassemblies as appro-
priate. U p-front identification of issues in these areas
will enable the organization to avoid surprise capital
needs and can drive dramatic reductions to introduction
costs. Design review is not intended to be a “show and
tell” lecture by design engineers. It is intended to be an

interactive process involving input from all who are or

will be involved with a product throughout its life cycle.
• Design verification. Verification is simply a comparison
of design output to input requirements to make certain
that the development project is on track.
• Design validation. Validation is a confirmation that the
product will meet actual application needs. This is best
conducted with direct contact with users and may involve
having them use product prototypes or development
models. For services, it may involve test sites where the
service is piloted with actual clients. Feedback from users
can be critical in making the best final product design
decisions. When users provide negative feedback, design-
ers have a golden opportunity to use their innovative tal-
ents to develop c ustomer-friendly solutions.
Each design and development control is more than an opportu-
nity to reduce the cost of the overall product development and
introduction program. It is also an opportunity to hone produc-
tion and service delivery processes and to f ine-tune the design
so that the product captivates the market.
If you’re not convinced that attention to, and control of,
product or service design is important, review your customer
complaints and Cost of Quality data to see whether delays and
costs could have been avoided if there had been a rigorous pro-
cess in place for controlling product and service design.
Speed has become a critical element in new product intro-
duction. In many cases, organizations have little time between
determining customer needs and introducing the product to the
marketplace. If that interval is too long, by the time the product
is introduced customers will have moved to competitors for the
next generation of needs.
ISO 9001:2008 clause 7.1, note 2, indicates that “the orga-
nization may also apply the requirements given in 7.3 to the

54 Chapter Four
development of product realization processes.” These tech-

niques can also be used for developing clause 7.5 (Production
and service provision processes), and such use should be a pri-
mary consideration. In fact, ISO/TS 16949 (Quality manage-
ment systems—Particular requirements for the application of
ISO 9001:2008 for automotive production and relevant service
part organizations) requires organizations to use clause 7.3 pro-
cesses for production-process development.
Why go to such trouble? Is it not enough to exercise this
degree of rigor in product design and leave process design to
be done the way it always has? The reason might surprise you:
speed! But, you may counter, won’t applying the same rigors
to process design that we do for product design just increase
total development time? The answer might be yes if the two
are viewed as independent activities, and if process develop-
ment is started late in the process as the product design is being
readied for release. But that “throw it over the wall to produc-
tion” approach was debunked decades ago. What is needed is a
fast, disciplined, and integrated process for developing product
and process design together. The tools stipulated in clause 7.3
can provide a structure for just such a development process.
One can, for example, contemplate the degree to which those
responsible for service delivery or product manufacturing are
engaged in the design review process.
Four elements are needed for fast, successful product and
process development:
1. Treat each design as a project. Use structured project
management with clear phases, including clear prog-
ress checkpoints and criteria. Conduct frequent and
rigorous project reviews. By requiring that design
stages be identified and that review, verification, and
validation activities be performed at each stage, ISO
9001 encourages an organization to use project man-
agement techniques.

2. ISO 9001 clause 7.3.1 requires the organization to

“manage the interfaces between different groups
involved . . . to ensure effective communication and
clear assignment of responsibility.” When managing
communication, simplicity is the most important objec-
tive. Complexity is often the most significant enemy to
success. Simple, small, integrated design teams may be
the answer. At the very least, minimize the interfaces
and reduce the complexity of communication.
3. Integrate development of the production or service
delivery process with the design of the product or ser-
vice. There is nothing in ISO 9001 that requires this,
but the better an organization can manage it, the sooner
the product will be released to customers.
4. Ensure proper planning, execution, and control of the
product and process scale-up processes. Often, products
that work well on a small scale or are easy to produce in
small quantities exhibit very different behaviors when
the organization makes full-sized versions or ramps
up to full production rates. In the authors’ experience,
issues related to these scale-ups are the single most
prevalent cause of failure in small businesses develop-
ing new technologies.
All of this involves more than just changing a company’s design
and development manual, setting up a few teams, and buying
project management software. To become speedy at develop-
ment, an organization must integrate these new methods into
the company culture. This means top managers must participate
in developing the new system so that they will understand and
support it. It means team members and other key people must
understand the new system, which implies a need for train-
ing and briefings during initial projects. Top managers must
conduct periodic reviews of the effectiveness and efficiency of

56 Chapter Four
the projects under way to determine what changes or improve-

ments should be made to the new development system.
We all know that cultural change is difficult. It is difficult
and sometimes impossible to achieve a direct change to a cul-
ture, so improvement must be achieved by getting people to
change their behavior. Top management needs an implemen-
tation plan that addresses the change aspects of integrated
product and process design. The planning should identify
behaviors that must be changed and how those changes will be
implemented. Perhaps the most important thing is to make the
changes so substantial that falling back into old habits becomes
more difficult than using the new, improved method.
The result of implementing such a development system
should be the faster introduction of products that meet cus-
tomer requirements and command higher market shares and
sales margins. To do this, an organization needs an integrated,
fast, and disciplined development process. Much of what’s
needed to achieve this is described in ISO 9001.
Addressing Correction, Corrective

Action, and Preventive Action
Quality professionals often say things like, “The audit program
is the centerpiece of our quality system,” or “Management
review is the heart and soul of the system,” or even “Customer
satisfaction is the most important thing we manage.” We seldom
hear that corrective action is as important as these things, yet
correcting the causes of things that go wrong is often the sole
way we can improve our ability to meet customer needs. It is
unfortunate that corrective action is not even on the radar when
most quality managers think about “important” processes. One
reason is that corrective action is not always the right thing to
do, as in the following examples:
• We make the assumption that the process was planned
correctly and that any problems must be the fault of the

people who run the process. Since this is assumed to be

true, our corrective actions are simple discipline actions—
and they always fail to address real causes.
• We already know the cause, so there is no need to find it.
However, we might be able to list several possible cause
removal actions and decide if any of these actions will
correct the cause in a cost-effective manner. If such an
action exists, we should take it.
• There is no effective, efficient corrective action available.
Perhaps the most economical action is too expensive to
implement in a reasonable amount of time. Perhaps we
will need capital investment to update technology. Or
we might decide that we have higher priorities; perhaps
we face other quality problems that are far more impor-
tant to our customers.
• We have a very bad situation, but we do not need to know
or correct the cause. Sometimes disastrous things happen
with a process that we might never use again. In other
words, we must deal with the nonconforming situation,
although the cause itself is irrelevant. Suppose, for exam-
ple, you take a once-in-a-lifetime boat ride down a swift
river. If you fall out of the boat, your immediate actions
must involve getting back in, not worrying about why you
fell out in the first place. If you never intend to get on
another boat, perhaps it is better to forget the incident
rather than spend time pondering why it occurred.
Because legitimate reasons can and do exist for not addressing
causes, some organizations will go to great lengths to avoid
solving critical problems. They look for excuses not to take
real corrective action. But this is not the only reason correc-
tive action is often ignored. Another is that most of us have
long held a very narrow view of what defines corrective action,
often confusing it with correction.

58 Chapter Four
Correction is an action to eliminate a detected nonconfor-

mity, while a corrective action eliminates the cause of a detected
nonconformity or other undesirable situation. Many of us spent
years in environments where the concept of correction was
called “corrective action.” Yet for several decades, this term has
meant “correcting the cause.” We still encounter people who do
not understand or choose to deny the nature of true corrective
action. It involves making changes to the conditions, processes,
or operations that cause nonconformities, problems, or other
undesirable outcomes. Corrective action corrects causes so the
problems or nonconformities will not recur. The issue is not
that organizations do not correct causes. They do, but many
organizations do not do it often enough.
Some organizations have a different attitude about the con-
cept. They think about correcting causes all the time. Employ-
ees are encouraged to study problems and their causes (and,
if they are authorized to do so, implement changes that will
eliminate the causes and problems). What should organizations
do to achieve this attitude? First, they should create an expec-
tation that all employees will work on rooting out the causes
of problems. Everyone must have the tools to determine and
correct causes. Organizations should also provide a structure
for controlling changes and holding managers accountable for
the results. More important, they should encourage everyone in
the organization to change their thinking—to find and correct
causes rather than come up with stopgap measures to keep pro-
duction going. Shigeo Shingo describes this thought process
with an analogy. He points out that implementing stopgap mea-
sures is like using ice to relieve the pain of appendicitis when
what is needed is an appendectomy.1 It is quite a dramatic anal-
ogy because failing to get the appendectomy could result in
death. Is failure to address real causes endangering the health
of your organization?
While corrective action may be a key to future success
as causes of product and process problems are addressed and

corrected, the concept of prevention may be a near-term sur-

vival issue. It is interesting that so many companies resist any
formal effort to address preventive action. Just to satisfy audi-
tors, some organizations will even search through their correc-
tive actions to find a few issues to characterize as preventive.
But preventive action is not working on problems that have
already happened. Rather, it is looking ahead to what could
happen in the future. It seems obvious that an ounce of preven-
tive action costs much less than a pound of corrective action.
So why do organizations resist?
Perhaps it is because preventing every problem and non-
conformity may incur an unacceptable expense. Most organi-
zations do not apply preventive action at the optimal stage in
the development or management of a QMS. They do not think
about preventive action until long after it has ceased to be an
effective option.
ISO 9001:2008 makes a number of references to plan-
ning. Clause 5.4 tells us to develop quality objectives and then
plan the quality system to meet those objectives and customer
requirements. Clause 7.1 requires that we plan product realiza-
tion and determine how we will ensure that requirements for
the product are met. Clause 7.3.1 provides rules for planning
design and development processes—which means considering
the interrelationship of design review, verification, and valida-
tion with the various phases of the design work. Clause 7.5.1
requires that we plan the production and service delivery pro-
cesses so that they are conducted under controlled conditions.
The message should be clear: Well-planned processes are key
to a successful QMS.
The most appropriate time to consider preventive action is
during planning. Clause 8.5.3 states, “The organization shall
determine action to eliminate the causes of potential nonconfor-
mities in order to prevent their occurrence. Preventive actions
shall be appropriate to the effects of the potential problems.”

60 Chapter Four
There are three ways organizations can develop preventive

actions during the planning process:
1. Reduce complexity and the number of process inter-
actions. Every step, resource, and control adds new
interactions to a process and increases its complexity.
Because each step has at least two interactions (and
often many more) with other steps and processes, the
number of interactions increases much faster than the
number of steps. In terms of preventing nonconformity
or undesirable process performance, it is worthwhile to
consider simplifying processes.
2. Manage risk of failure. Organizations can use tech-
niques such as product FMEA and process FMEA to
assess the risk of future failures of new products and
processes. With such tools, risks are prioritized to help
assess which ones offer the most economical appli-
cations. Risk assessment tools are useful in evaluat-
ing and making cost and performance trade-offs for
products and mitigating risk associated with product
performance.2
3. Anticipate and manage uncertainty. Uncertainty can
be characterized as one of four types: process varia-
tion, foreseen uncertainty, unforeseen uncertainty, and
chaos uncertainty.3 In any organization, all of these
forms of uncertainty exist to some degree, depending
on the nature of the organization, its products, its cul-
ture, and the markets it serves. Managing unforeseen
uncertainty is very difficult, but developing strategies
for the other types is a good use of planning time. For
example, we can plan to use statistical process con-
trols to control uncertainties due to variation. How-
ever, if foreseen uncertainty is dominant (as it is, for

example, for organizations requiring FDA approval of

new drugs), then emphasizing contingency planning,
training, or d ecision-tree models might be more appro-
priate. For organizations facing unforeseen uncertainty
(for example, an army conducting a military mission),
conventional tools such as PERT charts might prove
useless; using a series of assessments of the exter-
nal conditions to uncover potential opportunities and
threats would be more effective. The information could
then be incorporated into strategy and tactics. Organi-
zations must be innovative during quality planning to
get the most from the preventive action concept.
Both corrective action and preventive action relate to elimi-
nating causes. You might think there is a difference in attitude
that relates to corrective action versus preventive action. It
is not a shift in attitude as much as it is a matter of adopt-
ing the right attitude to fit the situation. Corrective action
demands plan- do-check-act (PDCA) experimentation and a
problem-solving m ind-set. Preventive action requires a quite
different r ight-first-time (RFT) attitude. Both attitudes need to
be applied to the right situations at the right time. Figure 4.3
illustrates this.
Action Correction Corrective Preventive

action action
Problem Right the

Attitude Fix what fails
solving first time
Figure 4.3 Appropriate attitudes and actions.

62 Chapter Four
Managing Incremental and

Breakthrough Improvement
In Chapter 1 we discussed the difference between incremen-
tal and breakthrough improvement. Maintaining a clear under-
standing of this distinction is important for an organization
committed to improvement because it is easy to choose inap-
propriate improvement tactics. There are potential traps in the
continual improvement concept when organizations expend
large sums of capital to achieve small gains or expect great gains
from employees with no improvement budget. Recognizing the
distinctions and applying them to each opportunity is key to
achieving planned improvement. Making lasting improvements
necessitates improving organizational processes. For example,
it is obvious that improving part conformity with requirements
often requires better process capability. However, it is less obvi-
ous that an apparent need for a better product design requires
a better design process. Often, continual improvement requires
eliminating the real causes of problems. To the purist, there are
two basic types of causes: common and special. To the pragma-
tist, there are three:
1. Special causes, which aren’t part of the planned process
2. Common causes, which are inherent in the process
3. Phantom causes, which are situations or conditions
that appear to be causes and are often “corrected” but
have no real effect on the process
Sometimes sustained improvement is not achievable unless
several processes are changed. In the case of improving a
product design, it might be necessary to change the design and
development process, but it also may be necessary to change
the process for hiring designers, the capital allocation process,
and the process for understanding customer requirements. In
such a case, overall system changes are needed; simply starting

a new product design project may be the organization’s worst

approach.
ISO 9001:2008 has requirements to use the management
system itself to determine the need for changes and to make
changes. It also contains a crucial requirement for a manage-
ment review process. It is the job of top managers to perform
the reviews and plan the changes to the system that are needed
in order for the organization to prosper.
The management review process must be set up so that it
uncovers issues requiring immediate action to make certain that
the system remains functional in the face of external or internal
changes or new needs. Quality managers must recognize when
external changes demand innovative internal adjustments.
They must learn to put together the data and analyses that show
what should be changed and why. And they must bring these
issues to management reviews in ways that are easy for top
managers to understand. It is a difficult task for quality manag-
ers to position issues requiring short-term change in a manner
that is compelling to top management. To do so for issues that
address long-term survival is an even bigger challenge. More
about management review can be found in Chapter 7.
The Relationships among Policy,

Objectives, and Alignment
To get everyone involved in improvement, organizations must
understand and practice alignment. It might seem obvious
that organizational objectives should align with the actions
of every employee. Yet for many organizations, business and
quality objectives are not even clear, much less aligned. Some
have never thought about their business objectives in sufficient
detail to commit them to measurable analysis. In other organi-
zations, top managers are unwilling or unable to share informa-
tion about overall objectives (see Figure 4.4).

64 Chapter Four
Tactics
Mission Vision Objectives (Ys) to meet Measures (Xs)
objectives
Tactic 1 Measure 1 (X1)

Management review Inputs
Tactic 2 Measure 2 (X2)
Etc.
Outputs
Action items:
• Changes
• Mid-course corrections
• Reallocation of resources
• Affirmation or change of objectives
Figure 4.4 The role of management review in improvement.
It is easy to see that reducing production problems reduces

cost. It is also true that better products and services will attract
new customers, increase market share, and improve revenues.
But those higher revenues and lower costs will not happen just
because you declare, “We will improve the quality of everything
we do.” Alone, such pronouncements do nothing to improve an
organization because they are too general. Often, they have an
effect that is the opposite of what was intended. They dissipate
energy and create internal frustration.
We are far better served by setting objectives that enable us
to focus on improving the most important elements. Top man-
agers and quality leaders are responsible for harnessing quality
improvement to increase revenue and reduce costs. Measurable
quality objectives are needed that have demonstrable direct
relationships to the organization’s financial future. For exam-
ple, a business objective such as “increase sales by 10%” can
be driven by a quality objective—say, “improve customer sat-
isfaction by 33% over two years, and measure progress through
surveys.”

It is important to understand that we want to measure inde-

pendent variables, not just response variables. We can control
independent variables; response variables are controlled by one
or more independent variables. Figure 4.5 illustrates this notion
with the example of measuring the amount of sugar to change
sweetness of taste.
Returning to our example, an objective such as “improve
customer satisfaction by 33% over two years, as measured by
surveys” is a response variable. However, measurements like
this will often prove inadequate because they are controlled by
independent variables. It is necessary to develop a set of key
measures that will drive performance. Targets should be set for
each measure so that when they are reached, the organization’s
objectives are met.
To drive 33% improvement, it is necessary to measure
the independent variables that will improve customer percep-
tion. For example, we should identify the factors that are most
important in gaining and retaining customers. We should also
identify the processes that are involved and measure the inde-
pendent variables—those elements we can control—to increase
customer satisfaction.
Response variable: sweet taste
y = f(x) + ∑
∑ = random variation
y
• Understand the processes

and how they fit together
• Understand the relationship
between response and
independent variables
• Control the process
x
• Understand the variation
Independent variable: amount of sugar
Figure 4.5 M
easure process parameters that drive process output
results.

66 Chapter Four
Selecting important independent variables is not a trivial

task, and in many organizations the correct measures are not
obvious. Determining them often requires several rounds of
trial and error, but organizations should not guess at what they
need to measure. Too often, this produces poor results. In some
cases, measurements are made because collecting the data is
easy; in others, everything is measured, including things that
do not need to be measured. Measuring the wrong independent
variables or too many variables wastes resources.
If the correct objectives have been set, meeting them is the
most important goal an organization can achieve. This should
not be considered extra work; it is the work. This means top
managers must be involved in the most important improvement
projects. In most organizations there are enough improvement
opportunities for everyone to be involved at some level.
To develop a robust improvement process, organizations
must consider how they will align their workforce as well as
top and middle managers. This involves taking action on four
fronts:
1. Sharing information. Organizations must share their
objectives; it is also important to share the information,
measures, and data needed to recognize opportunities
and carry out improvement projects.
2. Changing expectations. Organizations must make it
clear that their expectations have changed. It is no lon-
ger sufficient to just do one’s job; everyone must also
learn how to improve it.
3. Managing boundaries. Organizations must set the
boundaries of action for all department levels. Although
companies should encourage every individual who
draws a paycheck to be innovative and make improve-
ments, they do not want to foster chaos.

4. Providing a supportive environment. Top and middle

managers must start behaving in ways that encourage
input from everyone. They must understand how to
gain the trust of their employees.
These are not new or revolutionary ideas. Quality professionals
have talked about them for years. Where would your company
be today if it had been acting on them for that long?
It might seem that alignment starts with the establishment
of clear objectives. But that may be the easy part. Our recent
experience indicates that there are a number of things that need
to be done before even thinking about the objectives. Organi-
zations pursuing registration to one of the management sys-
tem standards such as ISO 9001 or ISO 14001 would be well
advised to take time to review their mission and vision first (see
Chapter 1).
An organization’s mission is a statement of the organi-
zation’s reason for existing. It describes in high-level terms
what the organization is. It is crucial to getting a crisp, clear
understanding of the organization’s business and how it suc-
ceeds in that business. Mission statements may reflect how the
organization behaves, how it pursues business opportunities,
how it treats its people, or other information that is important
to the understanding of the organization. Since mission state-
ments express what the organization is, they seldom need to be
changed.
An organization’s vision provides a picture of the organi-
zation in the future. Understanding where the organization is
going, or needs to go, is often as critical as understanding the
current mission. Unlike the organization’s mission, its vision
may need to change over time. Vision is developed by first get-
ting a clear idea of the organization’s current situation (some-
times called the “current reality”) and then picturing what the
organization needs to look like in the future. The process starts

68 Chapter Four
with top managers, who work out their picture of the organiza-
tion’s future and share it with the employees. Their objective
should be to get employees to understand the top management’s
vision so everyone in the organization is heading in the same
direction and has the same idea of the ultimate destination.
An organization’s vision of the future may be quite different
from its current situation. The organization may have a vision
of becoming something very different from what is described
in its current mission statement. For example, the organization
may have the vision of abandoning its current lines of business
in favor of growth in other areas.
These notions are often given little real emphasis, and the
creation of mission and vision statements is sometimes an iso-
lated, idealistic exercise that brings little benefit to most mem-
bers of the organization. This is often because there is a lack of
honest dialogue on the real purpose and vision of top manag-
ers. It leads to such things as quality policies that have no direct
linkage to the organization’s real reasons for existing. This is
where the formal management system built around ISO 9001
or ISO 14001 comes in. It is in the proper development of the
quality objectives that the quality professional has the opportu-
nity to facilitate such honest dialogue.
In establishing objectives, an organization needs to consider
both its mission and its vision. If an organization has a vision
of becoming very different in the future, its long-term objec-
tives will be very different from its n ear-term goals. And both
long- and near-term objectives must be met. Setting goals with
the long term in mind without having adequate emphasis on
sustaining n ear-term performance is a prescription for failure.
In some cases, mission and vision can be developed inde-
pendently of one another. Often they are interrelated. They
should be the foundation for all that happens in the organiza-
tion. They should be reflected in strategies and in all of the
organization’s policies, including quality policy and objectives

that will facilitate the achievement of the statements in the

policy.
Developing and updating the organization’s mission, vision,
and overall business objectives should be made an integral part
of the organization’s strategic planning process. Including the
development of aligned quality objectives in the strategic plan-
ning process can also be a positive step.
The question “What are our quality objectives?” should not
be asked in isolation. Rather, the question should be, “What
are the things related to quality that support our organizational
mission and vision and overall business objectives, and what is
our policy related to those things?”
Objectives are one piece of the puzzle. Without a clear
vision and mission and a policy statement that is consistent
with the vision and mission, quality objectives will not achieve
the results they were intended to produce.
Simplicity and Systems Thinking

Organizations that have implemented QMSs conforming to ISO
9001:2008 can attest to the standard’s emphasis on using a pro-
cess approach to control and improve their systems’ processes.
ISO 9001:2008 requires organizations to identify, monitor,
measure, control, and improve their systems’ individual pro-
cesses. They must also determine the sequence and interaction
of these processes and describe them in their quality manuals.
Somewhat less emphasis has been placed on managing
interactions among those processes, and almost none is placed
on an important QMP: the systems approach to management.
The systems approach to management principle given in clause
4.3 of ISO 9004:2008 states: “Identifying, understanding and
managing interrelated processes as a system contributes to
the organization’s effectiveness and efficiency in achieving its
objectives.” When managing individual processes, we tend to

70 Chapter Four
look for direct, linear, c ause-and-effect relationships. With an

ideal process, we can measure and control a small number of
independent variables to control the behavior of outputs (i.e.,
response variables).
The systems approach is different in that it teaches us to
look at interactions between the processes. There are at least
two reasons for doing this. First, problems seem most obvious
at the interactions. But there is also the issue of complexity,
which increases along with the number of process interactions.
The number of interactions increases faster than the number of
processes. If a system includes three processes and each inter-
acts with the other, then there are three possible interactions
between them. With four processes, there are six possible inter-
actions; with five processes, 10 interactions; and so on. Often,
multiple interactions occur between any two processes. It gets
messy very fast.
All this complexity tends to separate cause from effect.
In other words, an action in one part of the system can have
dramatic consequences in other parts, and those consequences
often happen long after the action was taken. An example is
a quality improvement proposal that is initially resisted but
eventually accepted when it is turned into cost reductions that
cheapen the product. The subsequent rise in warranty costs is
blamed on the quality manager “not controlling the parts.”
In this example, various parts of the management system
reacted in different and unexpected ways. The finance people
thought the proposed improvement in quality was too expen-
sive. The design and industrial engineers got together and came
up with an alternative that reduced cost but had significant risk.
Somehow, the quality manager was not involved in the final
solution. The cost reduction part of the story was forgotten, but
the system tracked the item as the quality manager’s idea. The
point is that if the managers in this little situation had seen the
business as a system of interrelated processes, they would have

looked for the best overall results rather than just grabbing the
quick money and hoping there were no resulting problems.
When we focus on processes, we tend to focus on details.
However, we must understand how the whole system works
rather than search for direct cause- and-effect relationships.
Managers must understand what will happen if they make an
uncoordinated process change. It is this big-picture coordina-
tion that makes system management “magic.” In our example,
the interrelationship among the cost reduction process, the
quality improvement process, and the financial accounting pro-
cess needed attention.
Some techniques that can help with such big-picture think-
ing include:
• When your people work on improving one process, it is
the manager’s job to make certain other processes and
interactions are considered.
• “Think globally” and understand how the system’s vari-
ous processes work together to achieve the specified
results and the organization’s objectives. An organization
has one management system, but it has many compo-
nents. In addition to quality, it might include processes to
manage finance, investor relations, and so on. All parts of
the system must work together to produce results.
• Provide a simplified, graphic illustration of how your
organization’s key processes interact. Use care in under-
standing and describing these interactions. Keep in mind
that ISO 9001 requires that a quality manual include a
description of the interactions.
During the development of ISO 9001:2000, there was discus-
sion on whether to emphasize the process approach or the sys-
tems approach to management. Both principles are important,
but the principle underlying the process approach won out. It is

72 Chapter Four
simpler, easier to understand, and fits our linear way of think-

ing about cause-and-effect relationships.
Individual processes must be managed in such a way
that they are both efficient and effective in achieving desired
results. But the full “magic” of a management system will
never be realized unless an organization also understands
and manages process interactions as a system. Although such
big-picture thinking might appear abstract, it is necessary for
effective management of the system. Clear understanding of
process interactions is necessary for effective management to
be accomplished. Such systems thinking applies to both hard-
ware and software products.
A systems approach to management can help organizations
deal with complexity. B ig-picture thinking and a clear under-
standing of the interactions between QMS processes are criti-
cal if an organization is to deal with the effects of complexity,
of which there are two kinds:
• Detail complexity, which increases as more elements
accumulate. More parts in a product increase the com-
plexity of the process that created it. This is often viewed
as negative because of the increased potential for failure.
• Dynamic complexity, which increases with the number of
relationships or interactions in a system or process.
An old saying observes that “the devil is in the details.” This
may be true, but it is not just the details. For large systems or
processes, dynamic complexity causes the biggest problems.
There is more to the two types of complexity than meets the eye.
Controlling complexity is so important for software developers
that standardized ways have been developed to quantify it.4
Simple systems are always better when they meet both
requirements and objectives. But therein lies the rub. Since a
system must cover many processes it tends to be complicated,
and complexity makes it more difficult to control a process to

obtain consistent production of output that meets requirements.

Complexity not only increases the probability that processes
will go wrong; it also complicates finding causes when prob-
lems arise.
Creating simple systems seems easy, but this is a deception.
Most of the time it is not hard to just meet requirements, but it
is very difficult to accomplish tasks in the simplest and most
effective way. As an example, look at the typical action when
processes go wrong. Often the corrective action involves add-
ing a step to provide assurance that the problem will not recur.
If that extra step is effective, the problem might never happen
again. Still, the additional step has added complexity and may
well increase the chances of other failures.
What should be done about the complexity of QMSs in your
organization? First, decide how you will measure overall sys-
tem effectiveness. Although audit results can help, there must
be other measurements as well. Progress in meeting key quality
objectives should be measured or monitored. Select indicators
that reflect on the system’s overall output, such as customer
satisfaction scores or external quality failure costs.
Some of the steps organizations might consider to encour-
age simplicity include:
• Build controls and compliance into the process; avoid
adding extra steps or processes to meet a requirement
• Eliminate activities that have little or no value
• Organize the workplace so that objects are at hand when
and where needed
• Reduce the number of process interactions
• Reduce the number of activities in each process
• Reduce the number of process steps
• Limit the number of internal requirements needed to meet
specific ISO 9001 requirements

74 Chapter Four
• Encourage an organizational culture that avoids adding

activities or process steps to solve problems
For effective deployment in an organization, these steps might
require training both process creators and implementers. Some
organizations have found that a key first step is to treat all activ-
ities that do not add value as waste and eliminate activities that
are not absolutely necessary. Training in waste elimination can
be a good investment. Waste elimination reduces cost and com-
plexity, and it improves quality.
The basic message is that less is more. For any given expec-
tation of a hardware product, the fewer words written in pro-
cedures, parts included in the design, and people and machines
involved in production, the better the chances of producing a
quality product. A similar message is true of software: For a
given function, the less code written and the fewer engineers
involved, the better the chances of getting it right.
It could be time for you to become an advocate for simplic-
ity in your organization (see also Chapter 5).
Manage by Facts: The Importance

of Obtaining and Analyzing Data
Decisions should be made and actions taken based on facts sup-
ported by credible data. Decisions are made and actions taken
every day that are related to the measures of organizational
performance, product, and process quality. This means that the
well-run organization identifies the data sets it needs for analy-
sis. Of course, you can never have all the data you would like
for every situation, but a w
ell-thought-out data collection and
analysis strategy can make a significant improvement in the
quality of decision making in any organization.
Optimizing Documentation
We hear people say that ISO 9001 requires unnecessary doc-
umentation or that the documentation is too restrictive for

efficient operations. This is a myth! Effective and efficient doc-

umentation needs to be:
• Complete. The processes need to be described in an ade-
quate manner so that the documentation will be useful in
training, auditing, and actual operations.
• Useful. The form and content must be so well thought out
that the average employee with a question can refer to the
applicable document and find an answer.
• Easy to locate and access. Documents will not be used
by the workforce unless they are structured, filed, and
indexed in a u ser-friendly manner.
• Simple. This is a tough one. It is easy to make compli-
cated documents to cover simple topics. Simple is better.
Visual is better. Remember the saying that a picture is
worth a thousand words? Well, when it comes to docu-
menting production and delivery processes, it is often
true that a digital photograph says more than it is possible
to write down. A digital camera is often worth more than
any tool other than your computer!
• Online with liberal hyperlinking. Oh, we know, lots of us
older folks like to read paper. So what? Most workers are
very comfortable with finding and using documents in a
web-based environment. So put documents online, and
include liberal hyperlinks where appropriate.
Documentation also needs to be limited to what is needed
for the effective and efficient operation of the QMS. Yes,
limited. Of course, you need a quality policy, objectives, a
quality manual, and the few specific procedures required by
ISO 9001:2008 (hard copy, electronic, or a combination). That
is very little documentation. Of course, if you must conform
to one of the s ector-specific QMS standards (such as ISO/TS
16949) based on ISO 9001:2008, more documents may be
required. But ISO 9001:2008 clause 4.2.1 includes among the

76 Chapter Four
other requirements the notion that the organization must have

“documents needed by the organization to ensure the effective
planning, operation and control of its processes.” This is where
organizations often fail.
Instead of limiting themselves to those documents that
meet the test of “needed to ensure effective planning, opera-
tion, and control of processes,” they document everything. Big
mistake. Why? The simple answer is that having more docu-
mentation than you need causes complexity, and complexity
almost always causes problems. The important thing to remem-
ber is that the type and extent of such documentation is up to
the organization implementing ISO 9001:2008. You should be
free of outside pressure (especially from the often uninformed
opinions of auditors) to create documents that are not needed.
But this apparent freedom comes at a price. It means you have
a responsibility to think about what is needed and make compe-
tent, professional decisions on what documentation is needed
and how to create it!
Documentation developed with these ideas in mind may be
a great contribution to achieving a system that has efficient and
effective controls. But the reverse is almost always true: Poor
documentation structure or ill- prepared documentation will
almost always result in loss of system control.
But what about control of the documents we generate? ISO
9001:2008 clause 4.2.3 requires that the organization define in
a documented procedure the controls needed:
a. To approve documents for adequacy prior to issue
b. To review and update as necessary and re-approve
documents
c. To ensure that changes and the current revision status
of documents are identified
d. To ensure that relevant versions of applicable docu-
ments are available at points of use

e. To ensure that documents remain legible and easy to

identify
f. To ensure that documents of external origin are identi-
fied and their distribution controlled
g. To prevent the unintended use of obsolete documents,
and to apply suitable identification to them if they are
retained for any purpose
That is a very comprehensive list, and it is easy to audit.
Remember that if a document is necessary, it should be treated
as important to the business and be subjected to rigorous but
reasonable controls. Generate too many documents and the
controls get complex.
So, what is the basic message? First, good documentation
is the basis for disseminating a clear understanding of the QMS
and its requirements throughout the organization, and that clear
understanding is a basis for achieving control of processes and
assessing effectiveness through audits. But too many docu-
ments, or complex documents with complicated controls, are
a detriment to system effectiveness. It is the job of the quality
professional to help the organization select the right document
set to suit its needs and to make certain those important docu-
ments are controlled.
But make the controls as simple as is appropriate to the
circumstances and risks involved. The basic question should
be: Is the right information at the right place at the right time?
“Output Matters” as a Core Value

We need to stop perpetuating the myth that organizations can
be in conformance with ISO 9001 and still produce product
that does not meet customer requirements! Why does the myth
persist? We believe it is because standards implementers and
auditors alike tend to focus on conformance to the details of

78 Chapter Four
ISO 9001 and often lose sight of the basic requirements. Never

lose sight of the product! A claim that an organization conforms
to ISO 9001 should mean to the organization’s customers that
the organization is capable of consistent delivery of products
and services that meet customer requirements. An organization
that produces nonconforming product and is not able or will-
ing to take corrective action to eliminate the causes of these
problems should not make claims of conformity to ISO 9001.
We need to make certain our systems deliver conforming
product to our customers. The standard requires it and the cred-
ibility of ISO 9001 registration demands it. It is the output of
our QMS that matters to our customers!
Summary
The concept of effectively meeting requirements in an efficient
manner is often more complex than meets the eye. First, the
system must be developed to provide a design that will meet
the needs of ultimate users at a price the customer is willing
to pay. The design, production, and delivery processes must be
verified and validated to meet customer needs. Notions such as
correction, corrective action, and preventive action need to be
assimilated into the organization’s culture. Top managers must
work hard to achieve alignment of goals with all in the organi-
zation. Leaders need to manage by facts supported by credible
data. Top leaders must always keep their eye on the overall
system to avoid suboptimization. And all this needs to be done
in as simple a manner as can be developed.
What Can I Do Now?

To integrate the ideas in this chapter into your QMS, start by
planning a project or group of projects to address defined goals
for each topic. Work through the projects so that the organiza-
tion develops the capacity for correct execution of each item

before moving on to the next. Get one thing right at a time.

Keep things simple and consider how changes you make in
one part of the system could cause problems elsewhere in the
system.
Notes
1. S. Shingo, A Study of the Toyota Production System from an
Industrial Engineering Viewpoint (Cambridge, MA: Productiv-
ity Press, 1989).
2. C. A. Cianfrani and J. West, Cracking the Case of ISO 9001:2008
for Manufacturing (Milwaukee, WI: ASQ Quality Press, 2009),
162–165.
3. A. De Meyer, C. H. Loch, and M. T. Pich, “Managing Project
Uncertainty: From Variation to Chaos,” MIT Sloan Manage-
ment Review, Winter 2002: 60–67; J. West and C. A. Cianfrani,
Unlocking the Power of Your QMS: Keys to Business Perfor-
mance Improvement (Milwaukee, WI: ASQ Quality Press,
2004), chapter 5.
4. For an informative discussion of this subject, see Frank Hous-
ton, “Measurement of Software Processes and Products,” in
C. A. Cianfrani, J. J. Tsiakals, and J. E. West, eds., ASQ ISO
9000:2000 Handbook (Milwaukee, WI: ASQ Quality Press,
2002), 427–444.

5
Go Beyond
Where It Matters
A
powerful method for deciding where it is of value
to go beyond the requirements of ISO 9001:2008 to
improve the effectiveness and efficiency of a QMS is
to develop and deploy a s elf-assessment process.
What is a self-assessment? In Chapter 3 we discussed the
differences between internal audit and self- assessment. An
important distinction is that internal audit is a requirement of
ISO 9001 (clause 8.2.2) and s elf-assessment is not.
Internal audits provide confidence that processes are con-
tinuing to perform as intended and would provide evidence of
prudent judgment if issues of liability were ever to arise. Audits
are also a valuable source of input to the corrective action, pre-
ventive action, and continual improvement processes of an
organization. The value of the audit process is further enhanced
when it is integrated with management review.
Self-assessment is different. It is performed by, or at the
direction of, the organization’s own management and goes
beyond determining conformity with detailed requirements. It
is intended to evaluate the effectiveness and efficiency of the
organization and the maturity of its QMS processes. The output
of s elf-assessment can indicate:
• The conformity of processes to requirements
• The maturity level of the QMS processes
81
Chapter Five

82 Chapter Five
• Opportunities for improvement and innovation

• Priorities for improvement
• Best practices and processes that have potential for imple-
mentation in other areas of the organization
• Specific action plans to consider to improve product and
process efficiency and effectiveness
As we mentioned in Chapter 3, self-assessment can be fur-
ther explored by reviewing ISO 9004:2009 clause 8.3.4 and
Annex A—Self-assessment tool. In addition, the USA Tech-
nical Advisory Group to ISO TC 176 has published a docu-
ment titled Technical Report—Guidelines for Performing a
Self-Assessment of a Quality Management System. This report
is available from ASQ.
We also stressed that self-assessment is not a substitute for
internal audit and that it is not intended to conflict or compete
with the use of existing quality award or excellence models.
It is a tool that can enhance the identification of improvement
opportunities and the setting of priorities for the allocation of
the limited human and capital resources of an organization. It
is a tool that every organization should consider implementing
to go beyond the audit process required by ISO 9001.
How to Conduct a
Self‑Assessment: A Primer
There are many models for conducting self-assessment of a
QMS. The most recognized of these are national and regional
quality award models, also referred to as organizational excel-
lence models. Examples include the Baldrige Performance
Excellence Program and the European Foundation for Quality
Management (EFQM) Excellence Model. A common theme in

Go Beyond Where It Matters 83
all self-assessment models is the ability to determine the matu-

rity of an entire QMS or selected processes and to identify the
main areas for management to consider for improvement.
To initiate a self-assessment of an organization or seg-
ments of the organization, a simple and easy-to-use approach
is to divide the project into three phases: (1) planning the
self-
assessment, (2) conducting the self-
assessment, and
(3) reporting the self-assessment.
Examples of tasks to consider for the planning phase
include:
• Identifying objectives for the self-assessment based on
organizational needs
• Notifying management of the functions to be assessed
and the date and time of the assessment, and arranging
for staff participation that might be required
• Determining the scope of the assessment
• Obtaining pertinent reference materials for review, such
as performance data, prior assessment or audit reports,
relevant procedures, and related corrective and preventive
action reports
• Confirming the adequacy of the knowledge, skills, and
competence of the assessor to assess the assigned process
or system
• Establishing acceptance criteria for evaluating the perfor-
mance of the processes being assessed
• Preparing questions to determine the maturity of the pro-
cesses to be assessed and how to evaluate improvement
• Ensuring that issues related to integrity, confidentiality,
impartiality, and bias are addressed

84 Chapter Five
Examples of tasks to consider for the conducting phase include:

• Holding an opening meeting or communicating with key
individuals in areas to be assessed
• Observing processes, personnel, and documentation
• Ensuring that process outputs, including final product, if
applicable, meet requirements
• Asking questions
• Conducting effective interviews
• Gathering objective evidence
• Listening to what is said and not said
• Coping when no documented procedures are available
• Keeping excellent notes
• Analyzing objective evidence
• Synthesizing all that is seen and heard
• Drawing conclusions
• Summarizing observations and examinations of objective
evidence of conformity or process performance
• Holding a closing meeting
• Respecting the people whose processes are being assessed
• Managing time
• Handling uncertainty, ambiguity, and conflict
• Being cognizant of personal hygiene
Examples of tasks to consider for the reporting phase include:
• Stating the purpose, the scope, and the criteria used to
assess process maturity
• Identifying the assessor(s)
• Indicating the dates and places evidence was gathered

• Documenting the material, objective evidence obtained

• Noting the names and duties of individuals interviewed
• Providing overall conclusions in either a report or tabu-
lar format that state the basis for conclusions related to
conformity to requirements, best practices observed, and
opportunities for improvement relative to self-assessment
objectives
• Ensuring that all nonconformities (i.e., findings) are dis-
cussed with the responsible leaders and that the basis
for each nonconformity judgment is understood and
documented
These lists of tasks are not intended to be all-inclusive or
requirements—just a good starting point for those engaged in a
self-assessment process. Special attention should be directed
to ensuring the competence of assessors, since each activity
indicated above may require training, practice, and even a work
instruction or procedure.
Performance Maturity Levels

Another task at the front end of developing a self-assessment
process is to decide how to assess the level of maturity of a pro-
cess. One way is to consider the maturity continuum ranging
from level 1 (no formal system) to level 5 (best-in-class perfor-
mance) when evaluating a process or system. Table 5.1 shows
how a process can be assigned a maturity level using this method.
Conducting a S
elf-Assessment: A S
tep-by-Step Model
As an example of how a s elf-assessment could be performed,
consider the following scenario:
1. An organization’s management decides to assess the
organization’s management system maturity for the
processes included in ISO 9004:2009.

86 Chapter Five
Table 5.1 Performance maturity levels.

Maturity Performance
level level Guidance
1 No formal No systematic approach evident; no
approach results; poor or unpredictable results
2 Reactive Problem- or correction-based
approach systematic approach; minimal data on
improvement results available
3 Stable formal Systematic process-based approach;
system early stage of systematic improvements;
approach consistency of implementation is
evident; data available to indicate
conformance to objectives and
improvement trends
4 Continual Improvement process in use; good
improvement results and sustained improvement
emphasized trends evident
5 Best-in-class Strongly integrated improvement
performance process; best-in-class benchmarked
results demonstrated
2. The organization’s management assigns responsibil-

ity for conducting the assessment to an individual (or
team) who has the required training and competence to
perform a self-assessment.
3. The assigned assessor or team reviews all pertinent
documentation prior to initiating the assessment.
This includes a review of procedures, prior audit and
self-
assessment reports, performance data, and cor-
rective action records. In addition, the assigned asses-
sors should address, as appropriate, the other planning
phase activities listed above.
4. The appendix at the end of the book provides examples
of the kinds of questions assessors can consider when

evaluating the maturity of processes, following the

guidance in Table 5.1. The appendix provides a starting
point; it is not a comprehensive listing of everything an
assessor should consider during the performance of a
self-assessment. Assessors should augment the list of
sample questions in the appendix with additional or
different questions appropriate for the self-assessment
scope and objectives.
5. The assessor conducts the assessment for all processes
to be assessed considering the tasks listed earlier in the
chapter.
6. The assessor prepares and distributes a report of the
assessment considering the reporting tasks listed ear-
lier in the chapter.
Since the scope in our example is to assess the organization’s
management system maturity for the processes included in ISO
9004:2009 (see step 1), the assessor can use the questions in
the appendix as a guide or develop a unique set of questions
suitable to the needs of the organization. These questions can
provide guidance to ensure the assessor asks about process
inputs, realization activities, outputs, interactions, improve-
ment activities, and the handling of nonconformities or process
disruptions to assess the level of maturity of the QMS for the
processes being assessed.
If the scope of the assessment is assessing the maturity of
processes deployed to achieve conformity with ISO 9001, the
assessor can refer to the sample questions in ISO 9004:2000
Annex A clause A.3 for guidance.
Self-Assessment Reports
There are many possible ways to format a self-assessment
report. One reasonable approach is to state (or paraphrase)

88 Chapter Five
the questions that were asked to evaluate performance, the

actual performance observed, the assessors’ rating of the pro-
cess maturity (see Table 5.1 above), and any recommendations
for the assessee to consider. The assessment outcomes can be
summarized by subclause in a table such as the one shown in
Table 5.2. A typical self-assessment report would include a
table or other record for all processes assessed.
An assessor should remember that an assessment is not
complete until a report is documented and distributed. The
assessment report should take into consideration the tasks
listed earlier in the chapter, which are worth repeating here:
• Stating the purpose, the scope, and the criteria used to
assess process maturity
• Identifying the assessor(s)
• Indicating the dates and places evidence was gathered
• Documenting the relevant objective evidence obtained
• Noting the names and duties of individuals interviewed
• Providing overall conclusions in either a report or tabu-
lar format that states the basis for conclusions related to
conformity to requirements, best practices observed, and
opportunities for improvement relative to self-assessment
objectives
• Ensuring that all nonconformities (i.e., findings) are dis-
cussed with the assessee and that there is clear under-
standing of the basis for the nonconformity judgment
An assessment report that follows these guidelines will provide
significant useful information to both the process owners of
functions that have been assessed and to others in the organiza-
tion working on improvement projects.

Table 5.2 Example of reporting self-assessment results.
Improvement actions
Subclause Question Actual performance observation Rating to consider
6.3 Are there processes in place We have job descriptions but they 3 Consider asking HR to
to identify the professional do not articulate the experience or work with operations
and personal competences education required. This has resulted to improve our job
the organization needs in in hiring staff that are not fully description and candidate
the short and long term? competent to do the required work. screening processes
8.3 In addition to internal We have no formal process for this 1 Consider structuring a
audits is there a self- item. process to address this
assessment process activity—by whom, by
defined, documented, and when, and how?
deployed?
8.3 Are there effective Our process is better than any other 5 None required
processes established and process in the world for this item.
deployed for monitoring,
measurement, and
recording of process
variables and product
Go Beyond Where It Matters
characteristics?
89
11/2/13 12:39 PM
90 Chapter Five
Summary—Conducting a Self-Assessment
A self-assessment process may seem cumbersome to put into
practice, but once the front end is structured, the actual perfor-
mance of s elf-assessments is routine. Assessors make a plan,
ask questions, obtain responses, make maturity judgments, and
report results to management. Management decides where the
greatest value can be obtained by implementing improvements,
sets priorities, and allocates required resources.
The time required to perform a s elf-assessment depends on
its scope. Including preparation, performing the self-assessment,
and preparing a report, the time required can range from one
day to several days.
The data obtained from the self-assessment process are
much richer than audit report data and can provide the input
necessary to ensure productive deployment of both human and
financial resources.
Self-assessment can point the way to migrating a QMS
beyond mere compliance with ISO 9001:2008 requirements to
a QMS that can be a stepping stone to world-class performance.
Where Can Self-Assessment Results

Indicate a Need to Go Beyond
Minimum Requirements?
The limitless opportunities that can be discovered through the
self-assessment process can be either tactical or strategic in
nature. Based on our experience and various published reports,
we have selected and will discuss a few examples of both types
of activities that a w
ell-executed self-assessment could probe
and target for improvement.
Let us first consider a few examples of questions that could
be asked and investigated in a w ell-conducted self-assessment:
• Is there alignment of vision, mission, strategies, goals,
and process measures throughout the organization?

• Are quality professionals maintaining competence in a

rapidly changing environment?
• Is the dedication to meeting customer needs and require-
ments consistent throughout the organization?
• Are product realization processes robust (e.g., do prod-
uct, production, and delivery processes receive a formal
design review before release)?
• Are data collected, analyzed, and used? Are there formal-
ized processes for reporting and use of information?
• Is human resource management ensuring the active par-
ticipation of proper personnel in the hiring process and
ensuring the competence of staff?
• Do formal innovation processes exist? Who is the innova-
tion process champion?
• Are we considering and utilizing “magical” solutions such
as Six Sigma, lean, total quality management (TQM), sta-
tistical process control (SPC), and design of experiments
(DOE) methodologies?
• Is the organization using Cost of Quality methodology?
• How do quality assurance (QA) personnel participate in
organizational strategic planning?
• How does quality relate to the business? Is there evidence
of sensitivity to its impact on the income statement, the
balance sheet, and cash flow?
• Do QA personnel speak the language of executive
management?
• How is the organization addressing agility? Who is the
process champion?
• What capabilities does the quality professional need to
master?

92 Chapter Five
• Are the implications of globalization on the structure and

deployment of a QMS well understood, and how are they
addressed?
• Is the organization benefiting from the wisdom of selected
quality gurus? What are the key concepts of selected
gurus that could be understood and considered?
• Does the organization understand its value stream and
work to improve cycle times and add value?
• Has the organization developed its own principles to be
consistent with the QMPs and its own vision and mission?
• Does the organization have a proactive management sys-
tem focused on preventing problems and nonconformities?
The answers to such questions can focus senior management
on implementing processes that will expand the breadth and
depth of the QMS in a manner that is consistent with the vision,
mission, and objectives of the organization.
Using Self-Assessment to Expand QMS Scope:

Tactical Examples
Brief examples of how the results of self-assessment may be
used to expand the breadth and depth of the QMS are pro-
vided below to indicate how an organization can go beyond the
minimum and add value while doing so, starting with tactical
examples.
Is there alignment of vision, mission, strategies, goals,

and process measures throughout the organization?
In many cases a quality policy is a document that is visible in
the lobby of an organization but there is little or no evidence
that it has been embraced (or even understood) throughout the
organization. During a self-assessment it can be determined
whether objectives and processes are in place that ensure the

attainment of the policy statements. In a more global sense, the

consistency of vision, mission, strategies, goals, and process
measures can be assessed and any disconnects can be targeted
for improvement.
Are quality professionals maintaining competence

in a rapidly changing environment?
If the quality function is to remain current in a changing orga-
nizational environment, it is not sufficient to use tomorrow the
same methods that were used in the past—even the recent past.
To meet the challenges posed by new requirements for current
processes and to adapt to emerging requirements (e.g., inno-
vation, agility, learning), the quality professional needs to be
vigilant in expanding capabilities. Maintaining the status quo
is not an option.
Further, it may not be sufficient for the quality professional
to simply maintain competence in quality disciplines. The orga-
nization may expect quality practitioners to possess more than
just basic skills in areas such as finance, information systems,
technology, and environmental management.
Maintaining and expanding competence will be a continu-
ing challenge and will require a personal investment in con-
tinual improvement. A registration auditor may not be sensitive
to this issue, but the organization’s management should be.
Is the dedication to meeting customer needs and

requirements consistent throughout the organization?
To the dismay of several of us who participated in writing
clause 8.2.1, meeting customer satisfaction requirements is not
a specific ISO 9001 requirement. The wording in the require-
ments standard is very “wishy-washy,” to use a technical term.
The actual requirement related to customer satisfaction is for
the organization to monitor information relating to customer
perception as to whether the organization has met customer
requirements.

94 Chapter Five
If there is one issue that deserves probing with intensity

during self-assessment, it is the dedication to meeting customer
requirements at all levels of the organization—not just in a
policy statement but in deployed processes that are aligned to
achieving this objective at all levels. Such attention to customer
satisfaction would meet the intent of the first QMP—customer
focus—and make a meaningful contribution to ensuring the
sustainability of the organization.
Are product realization processes robust (e.g., do product,

production, and delivery processes receive a formal design
review before release)?
Clause 7.1 of ISO 9001 includes a requirement for ensuring
conformity of product to requirements: “Plan and carry out
production and service provision under controlled conditions.”
This requirement may be sufficient as a minimum but it does
not address efficiency (i.e., operating with minimal expendi-
ture of materials and labor).
There are many activities an organization can consider to
go beyond the minimum. One example is to require a design
review for production processes before they are launched, much
like what is required in new product development projects. A
few of the many areas that can be considered for going beyond
the minimum are (1) analysis of data, (2) preventive action/
risk assessment (e.g., conducting formal FMEAs), (3) manage-
ment review, and (4) competence of staff. The Malcolm Bald-
rige criteria and ISO 9004:2009 include many other areas that
can be considered as opportunities for expansion of process
robustness.
Are data collected, analyzed, and used? Are there formalized

processes for reporting and use of information?
Minimum requirements for analysis of data are contained in
clauses 8.4 and 8.5.1 of ISO 9001. The requirements descrip-
tions are weak. Going beyond the minimum is not a challenge.

An organization should consider, for example, establishing

formal objectives for many (or all) operations to measure pro-
cess performance, to analyze the data collected, and to use the
analysis to formulate and implement improvement projects. If
statistical analysis staff are available, analysis could be assigned
to them. Also, training on simple data analysis methodology
such as graphing using Microsoft Excel, calculating averages,
and performing process capability studies can be provided to
operating personnel to enhance data analysis and use.
If data are not analyzed and used, they are worthless—an
investment with no value derived.
Is human resource management ensuring the active

participation of proper personnel in the hiring process and
ensuring the competence of staff?
The requirements for human resource management are articu-
lated in clause 6.2.1 of ISO 9001. The requirements are not
specific regarding responsibility or the duties to ensure compe-
tence, yet this activity can have a profound effect on both the
efficiency and effectiveness of the execution of duties. In many
US organizations it seems that the primary function of the HR
department is not hiring and retaining competent staff—it’s
keeping the organization out of court.
Much can be done beyond the minimum requirements
needed to pass an audit. Consideration can be given, for exam-
ple, to (1) methods for initial determination of competence and
periodic competence reviews after hiring, (2) developing robust
interviewing methodology to weed out marginal applicants for
positions, (3) formal evaluation of training effectiveness, and
(4) formal records of personnel training and maintenance of
competence.
The quality function may be required to provide active guid-
ance to HR for hiring and competence maintenance activities
or to participate in the activities, since HR staff may be reluc-
tant to be aggressive in ensuring competence or may not have

96 Chapter Five
the capability to assess competence. As one HR professional

once stated, “You are too concerned with what the employee
does and how the job is done and not at all concerned with how
the employee feels!” Guilty as charged!!
Do formal innovation processes exist? Who is the

innovation process champion?
A loose definition of innovation is the development of new
solutions that meet new requirements or old customer and mar-
ket needs in a value-adding way. It is not mentioned anywhere
in ISO 9001, but it is a topic of great interest to senior manage-
ment because it is a key component of sustainability. It is men-
tioned in ISO 9004:2009, in the 2011 ASQ Future of Quality
Study, and in the 2012 Conference Board CEO Challenge.
Innovation is accomplished through readily available prod-
ucts, processes, services, technologies, or ideas. It differs from
invention because it refers to the better or novel use (including
the commercialization) of an idea or method rather than the
creation of the idea or method itself. So, it requires innovation
to take an invention from laboratory to marketplace. Innovation
differs from improvement. It refers to doing something differ-
ent rather than doing the same thing better.
The question to be answered is, do formal innovation pro-
cesses exist? Further, if processes do exist, do results indicate
that they are effective, and is there a process champion promot-
ing the quest for innovative products and processes?
Addressing innovation is beyond the current requirements
of ISO 9001 but is an essential component of a contemporary
management system.
Are we considering and utilizing “magical” solutions such

as Six Sigma, lean, total quality management, statistical
process control, and design of experiments methodologies?
“Magical” solutions to reduce defectiveness and improve qual-
ity have been employed for a long time. In his book A History

of Managing for Quality, Joseph Juran discusses “magical solu-

tions” the Egyptians used to build the pyramids, forerunners of
quality management.1
Magical solutions began arising early in the twentieth
century: control charts, sampling plans, quality circles, total
quality control, zero defects, and so forth. The list of magical
solutions is indeed long. Recent additions to the list include Six
Sigma, lean, TQM, SPC, and DOE.
Are any of the past or recent magical solutions worth con-
sidering for application in an organization? A serious question
to consider is whether the organization has anyone on staff that
would be responsible for understanding the methodology being
considered, and how and where it is appropriate to apply. This
is not a trivial question. Many organizations have launched Six
Sigma projects with an imperfect understanding of Six Sigma
tools and their appropriate application. By way of analogy, a
chainsaw is a useful tool when operated by a w ell-trained indi-
vidual, but it can create havoc (i.e., death or serious injury) in
the hands of an unskilled operator. How many professed Six
Sigma practitioners understand what is a random variable or a
cumulative density function? How often is a Six Sigma project
launched to address product nonconformity or waste due to an
ineffective product or process design review process?
Perhaps more important is the organization’s cultural readi-
ness to use such techniques. Without a culture that includes
natural collaboration and full alignment of everyone on meet-
ing the important objectives, “magic” techniques can create
waste and even chaos.
Self-assessment can probe the culture as well as the spec-
trum of analytical methods employed, the effectiveness of the
methods, the competence of the practitioners, and the readiness
of the organization’s people.
It is not uncommon for organizations to use sophisticated
techniques to address issues that could have been resolved with

98 Chapter Five
basic tools, or to be deluded into thinking that because some-

one has a credential (e.g., a Six Sigma Green Belt) a methodol-
ogy will be properly applied and produce the expected results.
Using Self-Assessment to Expand QMS Scope:

Strategic Examples
Is the organization using Cost of Quality methodology?
Since the language of management is money, it is often advan-
tageous to quantify quality performance in financial terms.
Most organizations that use the Cost of Quality methodology
measure costs in three broad categories:
• Failure costs—Costs incurred to repair or replace non-
conforming products, costs to r e-conduct nonconforming
services, costs related to customer complaints, and costs
to resolve warranty issues. Failure costs can be catego-
rized as internal or external.
• Appraisal costs—Costs incurred in inspecting, auditing,
and assessing the QMS for the processes or the product
itself.
• Prevention costs—Costs incurred in u p-front efforts to
ensure product conformity, such as performing FMEA or
risk analysis.
Some organizations collect only failure costs, ignoring appraisal
and prevention costs. This is often done for the sake of sim-
plicity and to focus the organization on correcting the causes
of product or service problems that might have an impact on
customers.
Remember, keep it as simple as you can when getting
started. It is also beneficial to engage the financial staff in
gathering Cost of Quality data. When finance personnel are
involved, the Cost of Quality data may have enhanced cred-
ibility (whether justified or not).

How do quality assurance personnel participate

in organizational strategic planning?
Strategic planning is a process in an organization that is intended
to answer questions like “Where are we now?,” “Where do we
want to go?,” and “How will we get there?” In order for the
answers to these questions to be actionable and meaningful, all
of the different functions in an organization need to be aligned
with them.
It is common in organizations for the answers to these
questions to be developed by representatives from finance,
marketing, sales, engineering, and product realization. It is not
common for representatives from “peripheral” activities like
HR and quality to participate in the top management discus-
sions where the strategic decisions are made.
The result of quality professionals not participating at the
front end of strategic planning is that QA can be relegated to a
reactive role rather than a proactive one. It is better if the quality
function makes the case for f ront-end participation in strategic
planning on the basis of both cost containment and customer
satisfaction. If QA participates in the strategic planning pro-
cess, it will be more effective in developing and deploying pro-
cesses that are available when needed and consistent with the
strategic plan of the organization, instead of trying to “bolt on”
metrics and controls after projects have been launched.
How does quality relate to the business? Is there

evidence of sensitivity to its impact on the income
statement, the balance sheet, and cash flow?
There are two aspects of this subject. First, the Cost of Quality
data collection and reporting discussed above is a good way to
start. But in most organizations, it is not sufficient. The second
aspect of this subject relates to the need to link the management
system process results to financial measures. What is the cost
of the process and what value does it add? What are the capital
costs for process equipment? How much working capital is tied

100 Chapter Five
up in equipment and associated raw material, in-process mate-

rial, and finished goods inventories?
Quality professionals need to cultivate sensitivity to the line
item contents of the income statement and the balance sheet (or
the analogous formats used by not-for-profit organizations) to
guide their conversations with management on justification of
improvement initiatives and requests for capital investments.
Do quality assurance personnel speak the language of

executive management?
The language of executive management is money, and the above
ideas can help you talk their language. Contextualizing internal
failure rates or external warranty costs in financial terms will
facilitate management support and funding of improvement
projects (also see Chapter 6).
How is the organization addressing agility? Who is the

process champion?
What is meant by agility? In the contemporary organizational
setting, agility is the ability of a system or a part of a system to
make rapid responses to change by adapting its initial configu-
ration to accommodate what has changed and to restore stabil-
ity to the system or subsystem.
Change, sometimes rapid change, is a phenomenon that all
organizations encounter. Rather than reacting to change after it
has taken place, it can be much more efficient and effective to
have prepared staff with the tools and processes for fast reaction
to or even anticipation of change. The ability to react quickly
(or anticipate) is a characteristic of an agile organization.
Risk management processes, lean production, and disaster
recovery plans are a few examples of activities organizations
can consider in its effort to become agile. There may also be
agility opportunities to consider for various components of the
supply chain.

What capabilities does the quality professional need to master?

It is necessary, but not sufficient, for a quality professional to
be competent in understanding and using QA tools such as
statistical methods, sampling, and DOE. In the contemporary
environment we recommend that the quality professional be
knowledgeable about business processes (e.g., inventory con-
trol, marketing, accounting, HR, sales, and finance) to maintain
credibility in an organization. Continuing education is becom-
ing critical. The quality professional must be able to develop
and get approval to implement processes that will improve
overall organizational performance. Without continuing educa-
tion, this may prove impossible in today’s environment of rapid
change.
Are the implications of globalization on the structure

and deployment of a QMS well understood, and
how are they addressed?
The involvement of many organizations in global commerce
has created many new challenges for quality professionals
(see also Chapter 6). To address these new challenges, quality
professionals will need to consider developing and deploying
processes to address new issues such as (1) the characteris-
tics of customers in different markets, (2) the outsourcing and
insourcing of parts and/or complete products, (3) cultural dif-
ferences in the concept of time, (4) differences in understand-
ing requirements for products and the work environment (e.g.,
some cultures see requirements as only advisory while others
see them as absolutes), (5) varying perceptions of the role of
workers in different cultures, (6) variations in how specifica-
tions and contracts are interpreted and executed, and (7) varia-
tions in the meaning of QMS certification.
The issues related to the globalization of commerce will
indeed require the quality professional to develop new skills
to address the challenges that will continue to emerge as

102 Chapter Five
globalization continues to mature. S elf-assessment can probe the

degree to which QA and other staff have acquired the competence
to address new issues that arise from globalization activities.
Is the organization benefiting from the wisdom of selected

quality gurus? What are the key concepts of selected
gurus that could be understood and considered?
Quality processes have been maturing for many years. It makes
sense for organizations to capitalize on and utilize the work of
individuals that have a proven track record. A few of the “giants”
of quality who are worthy of study include Joseph M. Juran,
W. Edwards Deming, Philip Crosby, Armand Feigenbaum, and
Acheson Duncan. In particular we suggest understanding the
following concepts and considering their applicability to the
current environment:
• Juran’s concepts of quality planning, quality by design,
quality control, quality improvement, and project by
project improvement2
• Deming’s 14 points3
• Crosby’s Quality Is Free and Zero Defects concepts4
• Feigenbaum’s Cost of Quality and total quality control
materials5
• Duncan’s Quality Control and Industrial Statistics mate-
rials6
These gurus (and many others as well) have published much
that is worth reviewing and considering for applicability to the
contemporary work environment.
Does the organization understand its value stream and

work to improve cycle times and add value?
Value stream mapping is a methodology for planning and link-
ing initiatives to implement and sustain improvement. It is often
used by organizations that are pursuing lean practices. The lean

paradigm has evolved from different sources, the most notable

being the Toyota Production System for waste elimination and
just-in-time flow. Value stream mapping is a valuable concept
for organizations to understand and consider for implementa-
tion. An objective of the application of this concept is to “be
lean” and not “do lean,” meaning that the organization should
consider processes that focus on increasing awareness of what
constitutes waste and pursuing improvements that eliminate (or
at least minimize) waste.
Application of this methodology requires learning the
tools, educating others in the organization on its purposes and
applications, and managing the value stream process to focus
on sustaining the improvements realized from the application
of value stream management.
Has the organization developed its own principles to be

consistent with the quality management principles and
its own vision and mission?
A foundation of the ISO 9001 family of standards is a set of
QMPs. These QMPs were developed by a diverse working
group committee of recognized quality experts from around
the world. This was over 20 years ago, yet these QMPs are
still applicable today. The QMPs and their implications should
be understood by all quality practitioners. The current version
of the QMPs can be found in ISO 9000:2005 (clause 0.2) and
ISO 9004:2009 (Annex B).
The quality professional should understand the implications
of each QMP in the context of the mission, vision, and objec-
tives of the organization. In addition, since the relative impor-
tance of each QMP will be different for each organization, it is
important that QMS priorities and processes address the QMPs
as appropriate, and that the mission and vision of the organiza-
tion are consistent with the QMPs. See Unlocking the Power of
Your QMS for further discussion of the QMPs and their interre-
lationship with vision, mission, and the QMS.7

104 Chapter Five
Does the organization have a proactive management system

focused on preventing problems and nonconformities?
Most organizations understand and address correction (action
to eliminate a detected nonconformity) when nonconformity or
process problems arise. Some even attempt corrective action
(action to eliminate the cause of a detected nonconformity). Few
organizations address preventive action (action to eliminate the
cause of a potential nonconformity) in an effective manner.
Effective and efficient management of performance is best
accomplished when processes are focused on both meaningful
corrective action (including root cause analysis) and preven-
tive action. See Unlocking the Power of Your QMS for a more
detailed discussion of the need for an awareness of and focus
on preventive action throughout the organization, including the
addressing of chaos and complexity and the anticipation and
management of uncertainty.8
Summary
“Go beyond” where it will have a favorable impact on the
organization and its customers. ISO 9001 is a good starting
point, but in most organizations there are system elements that
need to be more robust than what is required by ISO 9001.
Use an assessment technique like the one given in this chap-
ter to find those areas that can benefit from expansion of the
breadth and depth of your QMS, then set priorities and lead
improvement projects—as many as the available resources will
accommodate.
What Can I Do Now?
• Adopt a self-
assessment technique and conduct self-
assessments on all or selected parts of the QMS
• Review the alignment of vision, mission, strategies, goals,
QMPs, and process measures to ensure compatibility

• Assess the need for continuing education (e.g., in finance,

information systems, technology, and environmental
management)
• Review HR methodology for hiring and for maintenance
of staff competence and augment as appropriate
• Review the design review process for new product devel-
opment and consider initiating design review for product
realization processes as a form of proactive preventive
action
• Review processes for innovation and agility (create them
if none exist) and ensure process champions are identified
• Review the publications of quality gurus for ideas to con-
sider for the implementation, expansion, or modification
of deployed processes
• Consider implementing value stream mapping as a meth-
odology for minimizing waste
• Review and strengthen preventive action processes
including the implementation of appropriate training
(e.g., FMEA)
Notes
1. J. M. Juran, ed., A History of Managing for Quality (Milwaukee,
WI: ASQC Quality Press, 1995).
2. J. M. Juran, Juran on Quality by Design (New York: Free Press,
1992); J. M. Juran, Managerial Breakthrough (New York:
McGraw-Hill, 1995).
3. W. E. Deming, Out of the Crisis (Cambridge, MA: MIT Center
for Advanced Engineering Study, 1986), 18–96.
4. P. B. Crosby, Quality Is Free: The Art of Making Quality Certain
(New York: Mentor, 1980).

106 Chapter Five
5. A. V. Feigenbaum, Total Quality Control, 3rd ed. (New York:

McGraw-Hill, 1983).
6. A. J. Duncan, Quality Control and Industrial Statistics, 5th ed.
(Homewood, IL: Irwin, 1986).
ASQ Quality Press, 2004), chapter 1.
8. Ibid., chapter 7.

6
Future Quality
Management System
Challenges
I
n the previous chapters we examined the QMS from the
standpoint of activities that must be done to meet minimum
requirements as well as actions that can be considered to
expand the scope and depth of an existing QMS.
In this chapter we challenge quality professionals to adopt
an expanded view of their role. They should attack the more
philosophical aspects of our profession. These include closing
the communication gap that is often bemoaned by the quality
community and planning how the quality system will contrib-
ute to addressing the significant challenges to be faced in the
next several years.
We mentioned that there is a communication gap between
quality practitioners and staff in other areas of the organization
(e.g., engineering, marketing, finance, senior management). If
an objective is to expand the scope and depth of quality man-
agement in an organization, it seems rational to address the
question of how to bridge the communication gap.
It is also important for a quality professional to identify
the most significant strategic and tactical challenges the orga-
nization will confront in the future and think about how such
challenges present opportunities for the quality process to
play an integral role in the management of the organization. A
107

108 Chapter Six
related question that should be probed is what resources will be

required to meet future challenges.
The Communication Challenge

As we discussed earlier, quality professionals often do not
speak the language of senior management. To clarify this point,
consider the following 10 terms:
• RONA
• NPV
• LIBOR
• EBITA
• ECB
• ROGA
• AICPA
• SEC
• IPO
• FASB
Each of these common acronyms is understood and used by
senior management in most organizations, but it would be sur-
prising if a quality professional could contribute much to a
five-minute, in-depth conversation mentioning many of these
terms.
Now consider these 10 terms:
• ISO
• TQM
• MBNQA
• MTBF

Future Quality Management System Challenges 109
• UCL
• AQL
• FMEA
• DOE
• QFD
• CAPA
Each of these acronyms is understood and used by quality pro-
fessionals in most organizations, but it would be surprising if a
senior executive could participate in an in-depth conversation
including many of these terms.
We believe that a gulf exists between how executives (the
individuals who control the allocation of resources and set pri-
orities) think and make decisions and how quality profession-
als think and make decisions. In order for the quality discipline
to become recognized and respected in an organization, this
gulf needs to be bridged.
How to Bridge the Communication Gulf

Many books have been written on the subject of communica-
tion, and much of the content can be characterized as common
sense made complicated. So let us take the simple approach of
identifying a few areas where we can either start or improve
our current efforts to communicate about quality initiatives to
enhance the efficiency and effectiveness of internal processes
or customer satisfaction. Even if these areas seem obvious and
simple, it is worthwhile to remind ourselves of their importance:
• Avoid jargon
• Articulate what’s in it for the requestee (e.g., protect
jobs); make interactions win–win
• Diversify the knowledge base

110 Chapter Six
• Articulate features and benefits in business (e.g., finan-

cial) terms
• Understand the relationship between quality, the income
statement, and the balance sheet
We need to make a special effort to avoid qualityspeak when
interacting with colleagues. Quality terms like the 10 listed
above are only understood by “outsiders” in the abstract. We
are more effective when we communicate in terms of desired
outputs, process controls, and benefits. Even better would be
to quantify expected results in financial terms when working
with senior management. It is always a good idea to speak the
local language. If you order a meal in English at a restaurant
in southern France, the transaction is not likely to result in a
positive outcome.
If asked, everyone in an organization will state that they do
not have enough time to do their job (or a project or assignment).
Any quality-related request can be perceived as interfering with
people’s primary responsibilities. To overcome an immediate
negative reaction to a QA request, several approaches are worth
considering:
• Indicate what’s in it for the requestee
• Communicate the benefits that will ensue from the com-
pletion of a requested action
• State or imply that the completion of “minor” activities can
impact customer satisfaction and internal effectiveness
• Strive to communicate win–win requests for action
• Structure q uality-related requests not as extra work but
rather as an integral element of the work
By positioning quality issues as organization issues, the likeli-
hood of obtaining satisfactory attention and cooperation will
be enhanced.

In addition to reading the latest literature on q uality-related

topics, quality professionals can expand their overall man-
agement knowledge base and improve their ability to interact
with other departments in the organization by continuing their
development. Either by subscription, by visiting a library, or
by electronic means, the quality professional will gain valu-
able background on the issues important to senior management
by reading periodicals such as the Wall Street Journal, Forbes,
Barron’s, the Economist, the Harvard Business Review, the
Sloan Management Review, and many other similar publica-
tions. In addition, it would not hurt to read a best-selling busi-
ness book every year or re-read a classic (e.g., Peter Senge’s
The Fifth Discipline). An expanded understanding of the busi-
ness environment should facilitate communication and add
credibility to the alignment of the quality process with organi-
zational objectives.
Above we described the gulf that exists in communica-
tion between quality professionals and senior management and
highlighted the need to quantify quality initiatives in language
to which management can relate—i.e., in financial terms. An
effective technique for expanding the scope and effectiveness
of the QMS is to develop and deploy a Cost of Quality process.
This process quantifies the costs associated with prevention,
internal appraisal of product, internal failure costs, and exter-
nal failure costs. Instead of discussing a production area’s fail-
ure rate of 18 defects per day, a proposal for an improvement
project could be made on the basis of an investment of $8000
to eliminate $40,000 of rework costs. Senior management
understands that if $8000 is less than $40,000, the improve-
ment must be worth the investment. If the quality professional
wished to expand the QMS even further, a process to estimate
ROI for a project could be implemented. Management listens
when ROI calculations accompany a request for investment in
an improvement project.

112 Chapter Six
Improvement in some or all of these areas will not elimi-

nate communication gaps between quality staff and others in
the organization, but it can help, and there is no downside to
taking these or other similar steps to improve the effectiveness
of communication.
Planning for the Future

The quality function has a responsibility to plan for the future
to ensure that the QMS remains relevant. This should not be
done in a vacuum. The long-range quality planning for the
QMS needs to be aligned with the long-range plans for the
organization and consistent with its mission, vision, and objec-
tives. Such planning is an expansion of the intent and specific
requirements of ISO 9001.
To provide a starting point for preparing an organization’s
QMS for the future, we selected two reports to discuss: the
Conference Board CEO Challenge 2012 and the 2011 ASQ
Future of Quality Study. We selected these reports for several
reasons: (1) they are well written and easy to read and under-
stand, (2) the sources of the material included are credible,
(3) they represent a balance of viewpoints from both CEOs and
quality professionals, and (4) they are current.
Conference Board CEO Challenge 2012

The Conference Board is a global, independent business and
research association working in the public interest. Its mis-
sion is to provide the leading organizations of the world with
practical knowledge to improve their performance and bet-
ter serve society. The Conference Board is a non-advocacy,
not-for-profit entity. In the Conference Board’s 2012 report,
titled “The Conference Board CEO Challenge 2012: Risky
Business—Focusing on Innovation and Talent in a Volatile
World,” 776 top executives were surveyed to determine their
view of the most significant challenges their organizations will

Table 6.1 C
onference Board CEO Challenge 2012: Synopsis of survey
results.
Rank
United
Challenge Global States Europe Asia
Innovation 1 3 2 1
Human capital 2 4 7 2
Global political/economic risk 3 2 1 5
Government regulation 4 1 3 7
Global expansion 5 7 4T 3T
Cost optimization 6 5 4T 6
Customer relationships 7 6 6 8
Sustainability 8 9 9 3T
Corporate brand and 9 8 8 9

reputation
Investor relations 10 10 10 10
face in the future. A synopsis of the survey results is shown in

Table 6.1, which indicates the top 10 challenges for the world
and for US, European, and Asian participants.
It makes sense that the regional rankings would differ slightly
from the global ranking. For example, US CEOs are more con-
cerned with government regulation than Asian CEOs, and Asian
CEOs are more challenged by the talent pool in the labor market
than are CEOs in other areas. It is interesting that the overall US
rankings are similar to the overall global rankings.
2011 ASQ Future of Quality Study

In January 2011, ASQ began the process of identifying the
forces shaping the future of quality by inviting more than
270 thought leaders from all major sectors of the global

114 Chapter Six
economy—including International Academy for Quality mem-

bers, past ASQ medal winners, ASQ Enterprise members, and
individuals from the US quality community—to serve as pan-
elists in its sixth Future of Quality study.
Panelists were asked to identify 10 forces that they felt were
most likely to shape quality in the future. After several rounds
of refinement, panelists were asked to select the top 10 forces
and rank-order them. ASQ then finalized a list of eight forces
affecting the future of quality based on the input of its distin-
guished panelists. This list is shown in Figure 6.1. Readers are
encouraged to read the entire report, which is available to
ASQ members on its website (www.asq.org/asq.org/2011/09/
global-quality/emergence-2011-future-of-quality-study.html).
Using the Report Data to Plan for the

Future: Actions to Consider
As we have been discussing, quality professionals have a
responsibility to design the quality system to address the sig-
nificant challenges every organization will face in the next
several years. This responsibility is well beyond ISO 9001 but
within the intent of ISO 9004, since it has a direct impact on
how an organization will be managed for sustainability.
There is no single recipe for accomplishing this activity, since
each organization’s approach will depend on factors such as size,
products, and regulatory requirements as well as its vision, mis-
sion, and objectives. The information contained in the Conference
Board and ASQ reports does, however, provide a starting point.
One possible approach is to identify those challenges and
forces that are common to both studies and within the purview
Global responsibility Workforce of the future

Consumer awareness Aging population
Globalization 21st-century quality
Increasing rate of change Innovation
Figure 6.1 F orces affecting the future of quality.
Source: ASQ, “Emergence—2011 Future of Quality Study.”

of the quality function to impact. Then we can determine actions

to consider to turn these challenges into positive opportunities.
It is reasonable to start with a consideration of the challenges
articulated by CEOs, since top management sets the direction
for the organization, controls the availability and allocation of
resources, and is the ultimate decision maker regarding which
activities to pursue.
We suggest starting with the following challenges identi-
fied by the Conference Board CEO Challenge:
• Innovation
• Human capital
• Global expansion
• Cost optimization
• Customer relationships
What activities can the quality function consider to address each
of these challenges? We suggest the following as a starting point.
Innovation
It is becoming clear that innovation is increasingly the lifeblood
of an organization. With today’s rate of change increasing, no
organization can assure its future without the ability to bring
innovation to customers. Apple is a sterling example of relying
on innovation to create and dominate a market.
To foster innovation in an organization, the quality function
can:
• Ensure documentation and deployment of a formal inno-
vation process that identifies responsibilities and timelines
• Identify customers with whom alliances can be formalized
• Develop personnel through training on innovation skills
• Use customer feedback to identify wants, needs, and
requirements by implementing a voice of the customer
process

116 Chapter Six
• Consider implementing quality function deployment

(QFD) and other similar methodologies
Many other avenues can be considered to create an environ-
ment that promotes and values innovation. An organization is
only limited by the resources applied and the priorities assigned
by management.
Human Capital
Many factors combine to make the management of human
resources a priority, including an aging workforce, a multi-
generational workplace, an imbalance of skills and competen-
cies to meet current needs, changing technology, increased
customer expectations, and pressures to keep the workforce
current. Addressing these challenges will be a major area of
emphasis in the future.
Activities that QA can consider deploying to mitigate nega-
tive impact include:
• Focus HR processes on hiring competent staff that meet
minimum position requirements (vs. keeping the organi-
zation out of court)
• Promote internal training to maintain and improve skills
• Provide performance metrics to identify acceptable and
subpar performance (i.e., measure competence)
• Provide information to HR that enhances the organization
brand as a way to attract targeted talent
• Establish controls for work performed offshore or at alter-
native work locations (e.g., w
ork-from-home employees,
work performed via the internet in multiple geographic
locations)
Processes to ensure the continuing availability of competent
staff at all levels of the organization will require active partici-
pation and contribution from QA to ensure these processes are

deployed, measured, and controlled. Maintaining the compe-

tence of staff is too critical to the sustainability of an organiza-
tion to be viewed as an HR activity.
Global Expansion
Many organizations are involved in global commerce, which
presents a variety of challenges. Examples include (1) commu-
nication, (2) understanding customer requirements, (3) stabil-
ity of financial arrangements, (4) internet security, (5) variable
environmental regulations, (6) domestic and international labor
relations, (7) export/import regulations, (8) cultural awareness
and sensitivity, and (9) supply chain management. Even oper-
ating from several different locations within the United States
involves some (or all) of these challenges. And these challenges
will be exacerbated as organizations undergo both domestic
and international expansion.
Addressing these and other challenges in a way that main-
tains efficient and effective control of products while maintain-
ing profit (where applicable) will not be easy. Expansion of
the breadth and scope of the QMS will be required, as well as
a measure of luck and the ability to forecast and anticipate the
changes that are certain to occur.
To be effective in developing and implementing processes
to cope with global expansion of operations, activities such as
the following can be considered:
• Deployment of processes that require appropriate and
unambiguous specification of product requirements
• Review and enforcement of customer contract review
processes for international customers independent of the
source of the product
• Institution of projects to achieve compliance with organi-
zation- and customer-required registrations (for example,
ISO 14001, ISO 9001)

118 Chapter Six
• Controls for all components of the supply chain

• Use of design review methodology for new processes
prior to use
Addressing issues related to the globalization of operations
will present a significant challenge to quality professionals and
may require augmentation of current skills.
Cost Optimization
Cost optimization, when looking forward, is more than just cost
containment. It will require attention to all aspects of processes,
from customer requests to delivery and customer support, and
even to processes to ensure effective product p hase-out.
The quality function should shine when addressing such
challenges. Examples of processes that can be considered for
implementation (or expansion of scope if already implemented)
include:
• Institutionalizing lean and Six Sigma methodology to
eliminate waste and n on-value-adding activities
• Ensuring alignment of processes with mission, vision,
and objectives
• Implementing value stream mapping, process mapping,
and benchmarking
• Promoting FMEA to mitigate risk and minimize the Cost
of Quality
• Managing a Cost of Quality process to quantify, under-
stand, communicate, and lower costs
Attention to these activities as well as many similar ones is
well within the capability of contemporary quality profession-
als and can be technically easy to apply and even expand to
face future cost optimization challenges. But often their appli-
cation is dependent on the cultural base of the organization.
The technical stuff is easy, but hard work and time are needed

to change behaviors in a way that results in a culture of quality

improvement and prevention.
Customer Relationships
The very first QMP is customer focus. If an organization does
not have and maintain a customer focus, its sustainability is in
question. Customer focus is intended to encompass all aspects
of the relationship with customers.
In the past the most effective way of maintaining excel-
lent customer relationships was somewhat simplistic: deliver-
ing products that met customer requirements on time and at a
competitive price. In today’s marketplace, that approach is not
enough to ensure sustainability. The advent of the internet and
social media has complicated the processes required to main-
tain favorable customer relationships. Competition is arising
from new sources—for example, BRIC organizations (those
from Brazil, Russia, India, and China)—seeking new business
in the global marketplace. Product and service delivery issues
or problems receive rapid and wide publication (for example,
the Costa Concordia disaster in Italy, the BP oil spill, Bank
of America debit card fees) and can have a significant impact
on brand reputation, even if they are addressed as quickly and
skillfully as possible. Needless to say, organizations need a
contingency plan for such possible incidents.
In addition to continuing to deploy existing processes to
maintain and improve customer relationships, quality profes-
sionals can participate in developing new processes to address
the evolving marketplace realities. Activities that can be con-
sidered include developing and deploying processes for:
• Fast response to customer complaints from any source,
formal or informal
• Monitoring of social network sites for negative brand
postings and establishing defined responsibility for quick
response

120 Chapter Six
• Expanded use of the lost order review process to evaluate

if a threat is emerging from new global competition
• Development of agile methods to obtain customer
feedback
• Training of staff on the reasons for and importance of
quick response to customer issues and the consequences
of slow action
Expanding organizational processes for managing customer
relationships will be an opportunity for quality professionals
to emphasize the importance of paying attention to all aspects
of product quality. In the evolving marketplace, customers are
becoming better informed more quickly on issues related to
products and organizations. They also can articulate issues with
little restraint to the marketplace by way of the internet, with
the potential to damage the reputation of a product, a brand,
or an organization. The quality function can help develop and
deploy processes to ensure the maintenance of positive cus-
tomer relationships and to mitigate the impact of negative cus-
tomer experiences.
Summary
This chapter explored a few areas where the quality function can
assume an expanded role in an organization. We probed ideas
for bridging the communication gap between quality, top man-
agement, and other areas of the organization, a long-standing
complaint of quality professionals. Although both sides of
the communication gap contribute to imperfect communica-
tion, quality professionals should consider what they can do to
improve this real or perceived situation. We discussed several
approaches to explore.
We also explored the future of the quality function, using
studies to identify the areas where quality can assume an

expanded role in defining and deploying processes that will

address areas of concern to senior management. For selected
areas we explored actions that can be considered to address
anticipated future challenges that are of high interest to CEOs.
Creative actions to improve communication and address
future challenges will expand the role of the quality function
and require quality professionals to go beyond using current
methods and existing tools to find new ways to meet the chal-
lenge of change facing all organizations.
What Can I Do Now?

This chapter indicated actions to be considered to improve
communication and to address contemporary challenges facing
organizations. Since every organization is unique, the quality
professional should consider the suggested actions as a starting
point for the formulation of action plans to expand the breadth
and depth of the QMS.
Being concerned about future challenges is easy, but taking
action to address such challenges may be relegated to a low pri-
ority when many pressing issues require attention today. Mak-
ing time to think through and formulate action plans to address
future challenges that are not easy to quantify is very difficult
but it is important.
Right now we can:
• Assess the effectiveness of both horizontal and vertical
communication and determine what additional action
plans can be implemented to achieve improvement
• Assess challenges from the perspective of top manage-
ment and formulate action plans and timetables for the
development of processes that will ameliorate negative
impact on the organization

7
Revitalizing Your Quality
Management System
C
hapter 1 dealt with the question of why you would
want to conform to ISO 9001. This chapter deals with
a different but related topic. Organizations, like people,
go through cycles. There is the dynamic startup, a period of
growth, then periods of stability, and a return to a period of
growth. It is that last transition that is dangerous. Organizations
can get to the point where they are too stable, unable to even
picture what a new growth cycle might look like. For some, the
answer becomes the sale of the business. New products can be
a key to revitalization; so can adoption of technological pro-
cess changes. But we need to be able to see the need for such
changes. Often the formal management system does not pro-
vide the tools to identify needed changes.
The Stable State

Some people are very comfortable in a stable state. Stable eco-
nomic conditions are sought by most of us! Those who have
stable jobs in stable companies can thank their lucky stars. But
wait: Is stability just a mythical mirage? Is stability normal?
Think back over the past couple of hundred years. Has stability
reigned supreme? We think not; rather, it is disruptive change
that has dominated. This is more apparent in today’s world
123
Chapter Seven

124 Chapter Seven
than it has ever been. So, if disruptive change is the norm of

the times, why not lead the charge? Why sit back and watch
competitors drive the ship of change? Instead, get up on the
ship’s bridge and drive constructive change yourself! And stay
up there, because there is no time for complacency—no time
to rest and relax.
A robust management system can be a powerful ally in the
quest to drive constructive change.
How the System Should Work

A good QMS must be able to determine when changing condi-
tions require major changes to maintain its market relevance.
It is crucial to recognize when dramatic system changes are
needed. It is also important to be innovative when developing
those changes and to consider the issues to be addressed prior
to implementing them. The objective is to keep the organiza-
tion and its QMS relevant in the face of change.
Organizations that succeed over time have three charac-
teristics:
1. They are lifelong learners, always learning and growing
2. They have a way to determine the need to make basic
changes in their products and management systems
3. They are innovative about making those changes
In other words, successful organizations have the ability to
sustain their success over long periods regardless of external
forces such as pressure for vast improvements in products at
ever declining prices. They remain competitive in the face of
the external conditions, business cycles, and complacency that
drive their competitors out of business. They seem to thrive on
innovation and change.
Long-term sustained growth depends on the organization’s
ability to address a variety of issues together and at the same

Revitalizing Your Quality Management System 125
time. An organization’s leaders should consider asking ques-

tions such as:
• Do we use internal scans, self-assessment, and assess-
ments of external conditions important to the organiza-
tion in order to understand future requirements?
• Do we use innovation to understand future mission,
vision, and strategies needed to meet new requirements?
• Do we change objectives, targets, and key processes to
meet new or changing needs?
• Do we prepare the workforce for inevitable changes?
• Do we implement, maintain, and improve a new QMS to
meet future requirements?
Figure 7.1 provides an example of how such questions can be
integrated into the overall process of planning, deploying, and
improving the QMS.
Planning for the future is essential for long-term survival.
The strategic part of planning is often overlooked because the
focus is on evaluating current and projected market conditions
and forecasting short-term sales trends, revenues, and margins.
These tactical activities might be needed, but they only scratch
the surface of future market conditions. A logical extension of
the management system is to ensure that the organization has
processes in place to understand the future market and busi-
ness conditions it will face and to compare current and pro-
jected products and processes with that picture of the future.
This applies to more than just the organization’s products and
services. An organization must also plan changes to its QMS to
meet future needs.
The most important aspect of planning is determining key
processes. In most cases, yesterday’s processes will not meet
future needs. The need to maintain registration to management
system standards, such as ISO 9001 or ISO 14001, should
never be viewed as an impediment to such changes. Rather,

How about the
Is our
structure of the
organizational
organization?
Threats Strategic planning model OK?
s
Ideas
Issues
126 Chapter Seven
Internal and Mission Action plans
tunitie
external Vision statement and objectives
assessments
Oppor
Principles Alignment
Objectives
Prepare People
Innovation
workforce
Improvement
for change
Learning
Audit
Corrective and
preventive action Identify key
Do we need a processes
new system?
How can we improve

our products
And do not forget to plan for tomorrow! and processes?
Figure 7.1 C
onsiderations for sustaining growth.
11/2/13 12:53 PM
innovation should be used to achieve better processes that con-

tinue to meet the standards’ requirements. If this part of plan-
ning is not performed well, there could be dire consequences
for the organization. If it is done well, the time and money
invested in optimizing processes will have been well spent, and
there will be a high probability for long-term success.
The organization needs action plans to describe how it
will identify the processes most important to creating change,
achieving a new vision, and meeting new objectives. This work
should start with top managers and, as with determining mea-
sures and targets, it should also involve others at appropriate
levels. Most organizations will have already determined key
processes that are appropriate for the current conditions. The
issue is to determine which processes are important in achieving
the vision and the required future results. The action plan must
also assign responsibility for developing these processes with
timelines and integrating them with other system processes so
that the system is optimized to meet its new objectives.
As the old saying goes, “Plan well but don’t plan forever,
for without action, planning is useless.” It is important to take
action when it is needed, but without a robust planning pro-
cess, organizations can miss critical opportunities to ensure
their long-term success. The goal is not to get a good plan to
put on the shelf or to execute without challenge. Rather, the
development and implementation of an ongoing planning pro-
cess should be seen as a way to build in the ability to adjust
as conditions change. Figure 7.1 indicates many areas of both
strategic and tactical opportunity that can be used to improve
the processes that comprise the QMS.
People and the Quality System

We often lose sight of the basics of quality. Achieving quality
excellence is hard work and complicated, but everyone in the
organization needs to remember the basics.

128 Chapter Seven
ISO 9000:2005 defines quality as the “degree to which a

set of inherent characteristics fulfills requirements.” The defi-
nition seems to beg the question, “Whose requirements?” We
can simplify the ISO 9000 language and answer this question
with a short working definition: Quality is the degree to which
the characteristics of our product meet customer requirements
and our own internal requirements. Notice that quality is a vari-
able; it can be good or bad or anything in between. Quality can
be measured. But the QMS is about more than just measur-
ing how well we meet customer and internal requirements. It
is also about improvement. Achieving conformity to require-
ments and improving operations involves a lot of hard work
and often requires sophisticated analytical work. On the other
hand, everyone in the organization should have a basic under-
standing of quality and his or her role in achieving good qual-
ity! Each person needs to know the basics of quality and how
he or she can contribute.
When we strip away all the “baggage” in today’s environ-
ment, quality comes down to two simple concepts: satisfying
customers and improving performance.
Satisfying Customers
To understand customer satisfaction we need to recognize that
there is almost always a difference between our internal mea-
sures of quality and the perceptions of our customers. The fact
may be that your organization has provided a great product or
service, but the customer may not perceive it the same way.
Everyone needs to understand the importance of looking at the
product or service from the point of view of the customer.
Improving Performance
We should assume that our competitors are trying to improve—
improve service delivery, improve designs, lower costs, improve
efficiencies, and so forth. If we do not do the same, sooner or

later we will begin to fail in our efforts to satisfy customers.

And no matter how hard we think we are working, if customers
are not satisfied, something is wrong somewhere in the orga-
nization and the entire organization will suffer. Everyone has a
role in improving performance and satisfying customers.
A Role of Management Review

While most organizations say they are continually improving,
some organizations come and go while others are more lasting.
Often the success of an organization is attributed to luck or the
actions of a clever CEO. In the authors’ experience, organiza-
tions that succeed over time have three characteristics:
1. They are always learning and growing
2. They have a way to determine the need to make basic
changes in their products and management systems
3. They use innovation to make those changes
Wise leaders recognize that the long-term survival of their
organization depends on their ability to do things like:
• Identify opportunities and threats, and plan changes that
are needed
• Use innovation to meet new requirements
• Change objectives, targets, and key processes to meet
new needs
• Implement, maintain, and improve a new QMS to prepare
the workforce for inevitable changes
But figuring out what to change to ensure a sustainable organi-
zation is not easy. Some organizations make it look easy; per-
haps they are just lucky, or perhaps they know the secret of
success. There is a secret and it is a w
ell-kept one! It is difficult

130 Chapter Seven
to find the key changes that will make the system more effec-
tive and efficient if you focus all of your attention on individual
products and processes. Continual work to improve products
and processes is important. But it is not the secret. Instead, the
key is finding the innovative changes that will make a positive
impact on the whole system. Sometimes these changes are big,
but often they are small. What matters is that they are critical
to the organization’s survival. It is very difficult to find such
innovative changes unless you know a lot about the organiza-
tion, and it is almost impossible to get sufficient focus on such
critical changes if top managers are not engaged in finding and
making them. Innovation is an essential element of improve-
ment, and it does not happen by chance.
What does this business reality have to do with standards?
Management system standards like ISO 9001:2008 and ISO
14001:2004 contain requirements to use the formal manage-
ment system itself to determine the need for and make the
needed changes. They also contain a crucial requirement for
a management review process. It is the job of top managers to
perform the reviews and plan the changes to the system that
are needed in order for the organization to prosper (see ISO
9001:2008 clause 5.6).
Management review can be approached as an activity that
is necessary to maintain the ISO certificate for the organization
(not an uncommon approach), executed by way of an agenda
and a meeting that address nothing but mandated items. Or it
can be viewed as an opportunity to take a hard look at how the
organization is operating to meet both s hort-term and long-term
needs. The opportunity for quality professionals is to make cer-
tain the management review process is structured and operated
in a way that will enable top managers to determine what needs
to be changed, and to monitor the planning and execution of
those changes to ensure they are effective.
The management review process must be set up so that it
brings to the surface issues requiring near-term action to make

certain the system remains functional in the face of external or

internal changes or new needs. Quality managers need to learn
how to determine when external changes demand innovative
internal adjustments. They need to learn to put together the data
and analysis that show what needs changing and why. And they
need to bring these issues to management reviews in ways that
are understood by top managers. It is a difficult task for qual-
ity managers to frame issues requiring s hort-term change in a
manner that is compelling to top management (see the discus-
sions of Cost of Quality in Chapter 5 and communication in
Chapter 6). Addressing long-term survival issues is a real chal-
lenge. To be effective and respected, quality professionals must
be proactive as well as reactive.
In these days of ever-changing business environments,
chances are that whether you know it or not, your organization
is being threatened by changes in the dynamic environment
around it. If you are not yet doing so, now is the time to start
looking for the system changes you need to make. The result
of your management review process should be changes that
will improve the system and your organization’s sustainabil-
ity. Management review meetings should result in some adjust-
ment to the system; if you participate in two or three meetings
without such an occurrence, start asking more questions! If
management review does not result in change, you are wasting
time, and the process will fail. Study and consider all of the
elements in the cloud diagram shown in Figure 7.1.
Set the Bar

The notion of setting the bar for quality management can be
tied to the requirement in ISO 9001:2008 clause 5.4.1 that
“top management . . . ensure that quality objectives . . . are
established at relevant functions and levels within the organiza-
tion.” Reviewing and revising the organization’s objectives is
a part of the planning process. It is crucial to knowing where

132 Chapter Seven
the organization is and steering the course for the future. But
setting objectives and measuring progress is not sufficient as a
driver of dynamic change. Everyone in the organization needs
to be involved and doing their part to achieve objectives. To
make this happen, we need alignment.
Each Employee’s Role

Everyone in the organization has a role to play. Each person
should be provided with the knowledge and ability to satisfy
customers and improve performance. In this section we offer
some simple guidelines that any organization can use to make
certain this happens.
Guideline #1: Each employee must know what

they are expected to do
Everyone must know what is expected of them. In the real
world, that comes down to having communication and instruc-
tions that define the expectations regarding the job to be done.
Regular “state of the organization” briefings by management
foster commonality of purpose. Instructions can be commu-
nicated as written procedures, provided in training sessions,
or even described in photographs to facilitate the understand-
ing of requirements and expectations. It is difficult to provide
employees with too much information about the current and
future status of the organization and the importance of their
contribution to success.
Guideline #2: Each employee must have the

means to do the work
Employees must have the proper tools to do their job and the
training to do it right the first time. Employees need to be able
to measure the acceptability of their work. It does not make
sense to have great instructions for the work if the tools needed
to do the work are not available.

Guideline #3: Each employee must know if the

correct work is being done—and being done
in accordance with proper requirements
Having the proper training leads to the next guideline—the
need for each individual to be able to know that they have done
the intended work, and that they have done that work correctly.
That means workers need to be able to measure the “accept-
ability” of their work (“Does my work conform to require-
ments?” “Do I know that customers will be satisfied with my
work?”). When employees know they have met requirements,
the organization can have confidence that the customer will
receive a satisfactory product or service. The chain of activities
from customer request to product or service delivery will have
integrity.
Guideline #4: Each employee must have the

capability to adjust the process
When and where appropriate, workers should be able to adjust
the process to ensure output conforms to requirements.
Guideline #5: Each employee must know where

to get help
Employees should know where to go to get help when things
do not go as planned. Management should make it clear that
when problems occur, everyone is encouraged to seek assis-
tance, sound an alarm, or take whatever actions are appropri-
ate. Knowing that each employee has been empowered (and
encouraged) to seek help when needed contributes to the orga-
nization’s confidence in the quality of its products and services.
So, five questions that should be asked about each worker
and process are:
• Does the worker know what to do?
• Does the worker have the means to do it?

134 Chapter Seven
• Does the worker have a way of knowing that require-

ments have been met?
• Does the worker have the capability to adjust the process?
• Does the worker know where to go to get help?
A quick and easy test for workers, supervisors, and managers is
to ask these five questions for every process. The answer to each
question should be yes. We call this the “five yes” method for
making a quick assessment of process and worker acceptabil-
ity. If the answer to any of these questions is no, then corrective
action should be considered. Following these guidelines will
help each employee contribute to the satisfaction of customers
and the success of the organization. A better understanding of
the importance of quality by every employee is vital in today’s
competitive business climate. It should also help when the reg-
istrar’s auditors do their interviews!
Shared Vision
We must have used the words mission and vision a hundred
times in this book. We make no apology for that. We believe
organizational excellence and sustainability are dependent on
these concepts more than any others. Your objective should
be to achieve a state where each member of the organization
has a mission and vision that are aligned with, and perhaps
a part of, the organization’s mission and vision. This is often
referred to as “shared vision.” Imagine an organization where
an employee at any level who is presented with a choice makes
the same decision the CEO would make. In this example, the
employee has the same knowledge and data about the situation
that the CEO has. But the employee also has the same basic
value set as the CEO. It is hard to believe that shared vision is
attainable until you see it in a real organization. But the authors
have seen it in organizations big and small.

Shared vision happens when the organization’s leaders

are consistent in their talk and actions. Leaders need to share
information about the business, and they need to consistently
apply the strategies necessary to achieve the written mission
and vision.
Summary
Strong management systems are very helpful in identifying
a need to change. They detect disruptive changes both within
and outside of the organization and enable leaders to see future
directions so that the organization, not its competitors, drives
the marketplace.
What Can I Do Now?

Ask yourself:
• Is our business getting too comfortable with its stability?
• Are we considering all the elements of the cloud diagram
(Figure 7.1)?
• Are we being proactive?
• Do we have processes to conduct external assessments?
• Are we conducting s elf-assessment?
• Are we using the management review process as it was
intended to determine what changes are needed and drive
them?
• Do we review vision, mission, and short- and long-term
objectives and the alignment of what they say and mean?
• Are we using the “five yes” method for quick assess-
ment of a process and its associated human and physical
resources?
• What more do we need to do to achieve shared vision in
our organization?

Epilogue
I
SO 9001 contains a set of minimum requirements for the
QMS of an organization, but it is far from being a perfect
model. In fact, no system model can provide a complete
structure that will be successful in all situations! Remember, all
models are wrong but some are useful.
This book has addressed why and how ISO 9001 can be
useful to any organization. We discussed its minimum require-
ments and how to ensure processes are designed and deployed
to meet those requirements. We also probed many areas where it
makes good business sense to consider going beyond minimum
requirements to enhance effectiveness, efficiency, and cus-
tomer satisfaction. We provided many examples of processes
that should be considered to achieve these enhancements.
We also briefly discussed the interaction of the QMS with
the culture of an organization. Without the right culture, no
QMS will enjoy l ong-term sustainability. But there are no reci-
pes for culture management. Each organization must find its
own way. This concept may appear philosophical and intrac-
table, but if you want success, it cannot be ignored, even if it
is not clear where to start. Self-assessment is an essential tool
that can be used to guide the setting of priorities and deciding
what to do first.
It could be argued that quality systems work related to
short- and long-term survival cannot be pursued until cultural
137
Epilogue

138 Epilogue
issues are addressed. Or vice versa! Our recommendation is to

be aware of the interaction between the QMS and the culture
of your organization and shape both into a system that accom-
plishes the objectives of the organization—project by project
and day by day. It is a never-ending, challenging, and produc-
tive journey.

Appendix
Questions an Assessor Can
Consider in Planning and
Conducting a Self‑Assessment to
the Contents of ISO 9004:2009
Examples of the kinds of questions an assessor can consider

when evaluating the maturity of processes that address the con-
tent of ISO 9004:2009 are given below. These examples are
not intended to be a comprehensive list of the questions to ask
relative to each clause and subclause. They are examples to
guide assessors in developing their own set of questions that
are aligned with the actual processes to be assessed and the
goals and objectives of the organization. Such questions will
be different for each organization and depend on such factors
as the size of the organization and its products.
Clause 4 Managing for the Sustained Success of an

Organization
4.1 General
• Is the QMS structured in keeping with the eight QMPs?
• Is there evidence of involvement and support of top
management?
139
Appendix

140 Appendix
• Are the interests of relevant parties outside the organiza-

tion considered?
• Has the organization developed and deployed a set of
principles that is consistent with its mission, vision, and
business model?
4.2 Sustained Success
• Is there a process for monitoring the organization’s envi-
ronment, including changing business conditions, tech-
nology, threats, opportunities, and competition?
• What objective evidence exists to demonstrate attention
to sustainability?
• Do processes exist to encourage innovation and learning?
4.3 The Organization’s Environment
• Is there a process for identifying risks and changing
expectations of customers and society?
• Is there a process for considering the impact of chang-
ing product or service delivery requirements that may be
driven by innovation?
• Is there a process for assessing the impact on the organiza-
tion of evolving threats from current or new competitors?
4.4 Interested Parties, Needs, and Expectations
• Are the needs and expectations of interested parties (e.g.,
customers, shareholders, employees, suppliers, and soci-
ety) considered?
Clause 5 Strategy and Policy

5.1 General
• Has the organization established and deployed a mission
statement and a vision statement?

Self-Assessment Questions an Assessor Can Consider 141
• Are these statements communicated to and understood,

accepted, and supported by the people in the organization?
• Do current operations reflect the mission, vision, and cul-
ture of the organization?
• Is there evidence of alignment of management actions
with the stated vision and mission (i.e., is management
“walking the talk”)?
5.2 Strategy and Policy Formation
• Are there processes to monitor the organization’s envi-
ronment to determine if there is a need to review and
revise, as appropriate, its strategy and policies? Is this
process continuous?
• Is there a process to assess current process capabilities
and resources?
• Are related processes implemented, and do results indi-
cate they are effective over time?
• Is policy and strategy developed on a regular schedule?
5.3 Strategy and Policy Deployment
• Has the organization established and maintained pro-
cesses and practices that translate its strategy and policies
into measurable objectives?
• Has the organization evaluated strategic risks and defined
adequate countermeasures?
• Has the organization established and maintained pro-
cesses to keep interested parties informed?
• Has the organization assessed its current performance
and the root causes of past problems in order to avoid
their recurrence?
• Is there a process for setting, aligning, and deploying
objectives to all relevant levels of the organization?

142 Appendix
5.4 Strategy and Policy Communication

• Does the organization have a communication process that
considers its customers and other interested parties when
and as appropriate?
Clause 6 Resource Management

6.1 General
• Are there processes in place to provide, allocate, moni-
tor, evaluate, optimize, maintain, and protect the human
and financial resources needed for the achievement of the
organization’s objectives?
• Does the organization have a process for periodic review
of the availability and suitability of identified resources?
• Does the organization consider the risk of potential scar-
city when planning the availability of resources for future
activities?
6.2 Financial Resources
• Does the organization have a process for monitoring, con-
trolling, and reporting the allocation and usage of finan-
cial resources related to the organization’s objectives?
6.3 People in the Organization
• Does the organization have processes established and
deployed that empower people to take ownership and
responsibility to solve problems; assess personal perfor-
mance against individual job objectives; seek opportu-
nities to enhance their competence and experience and
promote teamwork; and share information, knowledge,
and experience within the organization?
• Are there processes in place to identify the professional
and personal competencies the organization needs in

the short and long term, in accordance with its mission,

vision, strategy, policies, and objectives?
• Are there processes in place to improve and/or acquire
competence in order to close competence gaps?
• Are there processes in place to review and evaluate the
effectiveness of actions taken to ensure that necessary
competence has been acquired by all levels of staff in the
organization?
6.4 Suppliers and Partners
• Are processes established and maintained to identify,
select, and evaluate suppliers and partners?
• Are there processes in place to encourage suppliers and
partners to improve their capabilities?
• Are processes established and maintained to ensure that
products or other resources provided by suppliers meet
the needs and expectations of the organization?
6.5 Infrastructure
• Is there objective evidence that the organization assesses
at appropriate defined intervals the suitability of the infra-
structure to meet organizational objectives?
• Is there objective evidence that the organization identifies
and assesses the risks associated with the infrastructure
and takes action to mitigate the risks, including the estab-
lishment of adequate contingency plans?
6.6 Work Environment
• Does the organization ensure that its work environ-
ment complies with applicable statutory and regulatory
requirements?
• Is there a process to assess at appropriate defined inter-
vals the suitability of the work environment?

144 Appendix
6.7 Knowledge, Information, and Technology

• Is there objective evidence of processes deployed to man-
age knowledge, information, and technology as essential
resources?
• Is there objective evidence of processes that consider how
to obtain from internal and external sources the knowl-
edge required to meet the present and future needs of the
organization?
• How does the organization capture the knowledge and
experience of people in the organization?
• How does the organization capture undocumented
knowledge (tacit and explicit) that exists within the
organization?
• What processes exist to evaluate risks related to changes
in technology?
• How does the organization address issues related to
its capability for rapid response to changing customer
requirements and new market realities (i.e., agility)?
6.8 Natural Resources
• How is the organization addressing environmental impacts
over the full life cycle of its products and its infrastruc-
ture, including design, manufacturing or service delivery,
product distribution, use, and disposal?
• Does the organization have processes for assessing the
availability and efficient use of natural resources?
Clause 7 Process Management

7.1 General
• Are the activities within each process adapted to the size,
objectives, and goals of the organization?

• Is the management of all processes, including outsourced

processes, adequate to ensure that they are effective and
efficient?
• Are process interactions and interrelationships consid-
ered and reviewed on a regular basis?
• Is there evidence of consideration of the quality princi-
ples of process approach and systems approach to man-
agement? (See Annex B of ISO 9004:2009 as well as ISO
9000 and the ISO 9000 Introduction and Support Pack-
age, titled Guidance on the Concept and Use of the Pro-
cess Approach for Management Systems.)
• Is there evidence that processes are planned and carried
out under controlled conditions?
7.2 Process Planning and Control
• Is there objective evidence that the organization has
determined and planned its processes and defined the
functions necessary for providing products that can con-
tinue to meet the needs and expectations of customers
and other interested parties?
• Is there objective evidence that the organization has
considered the need for the organization to develop or
acquire new technologies or develop new products or
product features?
• Have process interfaces and interactions been considered?
7.3 Process Responsibility and Authority
• For each process, has a process owner been identified who
has the responsibility and authority to establish, maintain,
control, and improve the process and its interaction with
other processes?

146 Appendix
• Do designated process owners have the competence and

authority to ensure the establishment, maintenance, con-
trol, and improvement of processes and their interaction
with other processes?
Clause 8 Monitoring, Measurement, Analysis,

and Review
8.1 General
• Does the organization monitor, measure, analyze, and
review its performance at appropriate defined intervals?
8.2 Monitoring
• How does the organization monitor its operational envi-
ronment and collect and manage the information that is
necessary for understanding present and future needs and
expectations?
• Are there effective processes established and deployed
for monitoring and recording process variables, outputs,
and product characteristics?
• How does the organization collect and manage the infor-
mation that is necessary for determining the need for
alternative, competitive, or new product offerings?
mation that is necessary to anticipate current and expected
changes in statutory and regulatory requirements?
mation that is necessary to assess current organizational
and process capabilities?
8.3 Measurement
for measuring and recording process variables, outputs,
and product characteristics?


for risk assessments and risk controls?
for gathering and analyzing data to assess customer sat-
isfaction as well as input from other interested parties?
for internal and external benchmarking?
• Are key performance indicators (KPIs) identified and
monitored or measured?
• Are KPIs appropriate?
• Do KPIs provide information that is measurable, accu-
rate, reliable, and usable to implement corrective actions
when performance is not in conformity with objectives,
or to improve process efficiency and effectiveness for
conforming processes?
• Is there an internal audit process documented and
implemented?
• Are internal audit reports reviewed by management and
auditees?
• Are internal audit reports used as an input to management
review and as a basis for consideration of improvement
projects?
• Are internal audit results aggregated over time and
reviewed for trends?
• In addition to internal audits, is there a self-assessment
process defined, documented, and deployed?
• Is there evidence of the use of the output of s elf-assessments
that are conducted?
• Is the staff that performs monitoring, measurement, audit,
and self-assessment competent?

148 Appendix
• Are self-assessment or audit results communicated as

appropriate?
8.4 Analysis
• Are there processes established and deployed to analyze
information gathered from monitoring the organization’s
environment and from identifying risks and opportunities?
• Are there established plans to manage the analysis process?
• Are process performance data analyzed?
• Is there objective evidence of management decision mak-
ing based on facts?
• How does the organization address changes in statutory
and regulatory requirements, labor markets, and other
resources that could impact the sustained success of the
organization?
8.5 Review of Information from Monitoring,
Measurement, and Analysis
• Is there a systematic approach to reviewing information
obtained from monitoring, measurement, and analysis
and to ensuring that the information is used for decision
making?
• Are reviews performed at planned and periodic intervals?
• Is there evidence of a process to detect trends?
• Is the review of information obtained from monitoring,
measurement, and analysis used for consideration of
improvement opportunities?
• Is the review of information obtained from monitoring,
measurement, and analysis used to assess the adequacy
of resources assigned to processes?

Clause 9 Improvement, Innovation, and Learning

9.1 General
• What processes address how improvement, innovation,
and learning can be applied to products and processes?
• Do these processes address the structure of the organi-
zation and support activities related to the management
system of the organization?
9.2 Improvement
• Has the organization defined objectives for the improve-
ment of its products, processes, organizational structure,
and management system through the analysis of data?
• Has the organization defined, documented, and imple-
mented a consistent, structured approach to continual
improvement? Is the approach effective?
• Are there results to verify the effectiveness of the approach
employed?
9.3 Innovation
• How is innovation encouraged? Is there a formal process?
• Do processes to encourage innovation address products?
Processes? The organizational structure? The QMS?
• Has the organization identified key personnel as champi-
ons of innovation initiatives?
• Is innovation risk assessed? How?
• Is preventive action to mitigate risks that may be inher-
ent in innovation initiatives an element of the innovation
process?

150 Appendix
9.4 Learning
• Does the organization promote and encourage improve-
ment and innovation through learning?
• Do formal processes exist throughout the organization to
encourage learning and the sharing of knowledge?
• Do formal processes exist for recognizing, supporting,
and rewarding the improvement of people’s competence?

Index
Note: Page numbers followed by f refer to figures; those followed by t refer to tables.
A cost of nonconformity and, 42,

43–44
actions
definition of, 33
alignment and, 66–67
described, 33
attitudes and, 61f
internal quality, 33–34, 39f
conformance, for ISO 9001:2008,
minimum requirements for, 38–39,
17, 22, 24–25
39f
corrective, 56–59, 61f, 104
principles of, conductors, 34
preventive ISO 9001:2008, 59–61,
process of, 35f
61f
quality improvement and, 32
agility, focus on, 7, 100
registration/regulatory compliance,
alignment, understanding, and
34
practice of, 63–69
scope and depth of, expanding,
actions taken, 66–67
41–44
management role and, 63–64,
sector-specific standards and,
64f
42–43
measurement and, 64–66, 65f
vs. self-assessment and
mission statement and, 67, 69
management review, 36–38
self-assessment tactical examples
stages of, process, 34–35, 35f
of, 92–93
supplier, 34
vision statement and, 67–69
tips for passing, 40–41
American Society for Quality (ASQ),
uses for, 32–33
26
auditors, principles of, 34
Future of Quality Study, 112,
113–114, 114f
analysis process (clause 8), 25, 27f B
attitudes, actions and, 61f Baldrige Performance Excellence
auditing, 31–45 Program, 82
categories of, 31 breakthrough improvement, 13–15
clause 8.2.2, 31, 33, 38 characteristics of, 14t
conducting of, 35f concepts of, 15f
managing, 62–63
151

152 Index
C core value, 3, 31, 77–78

correction, 58, 61f, 104
change management, 15–16
corrective action, 56–59, 61f, 104
globalization and, 101–102
cost of nonconformity, auditing and,
strategic planning and, 98–104
42, 43–44
changing conditions, quality
Cost of Quality process, 44, 98,
management system and, 93,
111–112
124–127, 126f
cost optimization, quality
clause 4, identification and
management system and,
management, 22, 24, 27f
118–119
clause 5, management responsibility,
Crosby, Philip, 102
24, 27f
customer relationships, quality
clause 6, resource management, 24, 27f
management system and,
clause 7, product realization, 24, 27f,
119–120
50, 51f, 53–54
customers, focus on, 6, 93–94
clause 8, measurement, analysis, and
customer satisfaction, 128
improvement, 25, 27f, 31, 33, 38
clause 9, improvement, innovation,
and learning, 27f
D
communication data analysis, 74–77, 94–95
acronyms and, 108–109 Deming, W. Edwards, 102
Cost of Quality process and, design of experiments (DOE), 97
111–112 design review, product, 52–53, 52f
gulf, bridging, 109–110 design validation, product, 52f, 53
negative reactions, overcoming, design verification, product, 52f, 53
110 development, product, 53, 94, 105
quality professional continued documentation
development and, 111 data analysis and, 74–77, 94–95
quality professionals and requirements for, 76–77
executives, between, 108–112 Duncan, Acheson, 102
qualityspeak, avoiding, 110
competence requirements, ISO E
9001:2008, 48–49 effectiveness, 12–13
Conference Board CEO Challenge, addressing, 47–48
26, 112–113, 113t efficiency, 12–13
challenges identified by, 115–120 addressing, 47–48
conformity, ISO 9001:2008, 1–4, 2f, employee’s role in quality
16–17 management system, 132–134
middle managers reasons for, European Foundation for Quality
2–3 Management (EFQM)
organization reasons for, 1, 2f, 4 Excellence Model, 25, 82
survival and, 4 excellence models, processes derived
sustainability and, 3–4 from, 25–26
top managers reasons for, 3
workers reasons for, 2 F
consumer awareness, 29 facts, decision making and, 8
continual improvement, 8 failure modes and effects analysis
causes of problems and, 62 (FMEA), 16

153
Index
Feigenbaum, Armand, 102 certification audit, tips for passing,

first-party audits, 31 40–41
future, focus on, 7 competence requirements of,
48–49
G compliance with, 12–16
global expansion, quality conformance actions for, 17, 22,
management system and, 24–25
117–118 conformity with, reasons for (see
globalization, 26, 28, 101–102 conformity, ISO 9001:2008)
corrective and preventive action,
H 56–61
data analysis and, 74–77
A History of Managing for Quality
effectiveness and efficiency,
(Juran), 96–97
addressing, 47–48
How to Audit the Process-Based QMS
to establish QMS foundation, 5–12
(Arter, Cianfrani, and West),
incremental/breakthrough
34, 35, 39
improvement, managing,
human capital, quality management
62–63
system and, 116–117
intent of, 16
human resource management, self-
levels of adherence to, xv
assessment tactical examples
minimum requirements for,
of, 95–96
expanding beyond, 4–5
processes for conformity to, 22,
I 24–25
identification and management product and process validation,
(clause 4), 22, 24, 27f 49–56, 51f, 52f
improvement product conformance and, 77–78
alignment and, 66–67 systems approach to management
breakthrough, 13–15 and, 69–74
continual, 8 ISO 9001:2008 Explained (Cianfrani,
incremental, 13–15 Tsiakals, and West), xv, 12,
management review role in, 64f 39, 41
process (clause 8), 25, 27f ISO 9004:2009
incremental improvement, 13–15 for conformity, 22, 24–25
characteristics of, 14t processes from, 26–29, 27f
concepts of, 15f questions for planning/conducting
managing, 62–63 self-assessment to, 139–150
innovation ISO 9004:2009, Quality management
continual, 8, 29, 96 systems—Managing for
quality management system the sustained success of an
(QMS) and, 115–116 organization, xv
interrelated processes, managing ISO-compliant process,
system of, 7 implementing, 12–16
ISO 9001:2008 change management and, 15–16
alignment, understanding, and continual improvement and, 13–15
practice of, 63–69, 64f, 65f process effectiveness/efficiency
auditing and, 32–33 and, 12–13

154 Index
J P
Juran, Joseph, 97, 102 partner development, 8
people
L organization and, 8
leadership, providing, 7 process use by, 20, 21f
lean, 97 quality management system and,
learning, continual, 8 127–129
performance, improving, 128–129
M plan-do-check-act (PDCA), 61
prevention, 59, 98, 111, 119
“magical” solutions, 96–98
preventive action, 59–61, 61f, 104
Malcolm Baldrige National Quality
developing, during planning
Award, 25
process, 60–61
management, systems approach to,
ISO 9001:2008 references to, 59
69–74
problems, causes of, 62
benefits of, 71–72
processes
big-picture thinking techniques, 71
change management, 15–16
complexity and, 72–73
continual improvement, 13–15,
described, 69–70
14t, 15f
processes and, 70–71
control mechanisms of, 21, 21f
simplicity, steps to encourage,
defined, 20, 20f
73–74
derived from excellence models,
management responsibility (clause 5),
25–26
24, 27f
effectiveness, 12–13, 47–48
management review, 36
efficiency, 12–13, 47–48
role of, in quality management
from ISO 9004:2009, 26–29, 27f
system, 129–131
resources people use within, 20,
management systems, integrating,
21f
28–29
support of, 21f
managers, top
well-managed example of, 24f
ISO 9001:2008 conformity and, 3
process management. See also
mission/vision statements and,
processes
10–11
basics of, 20–21, 20f, 21f
quality professional and, 9
ISO 9001:2008 needs of, 22,
tasks of, 9
24–25
measurement process (clause 8), 25, 27f
quality management system and,
mission statements
19–30
alignment and, 67, 69
system management and, 21–22,
revising, 10–11
23f, 24f
product and process validation, ISO
N 9001:2008, 49–56, 51f, 52f
nonconformity, cost of, 42, 43–44 elements of, 54–55
product design
O review, 52–53, 52f
objectives, alignment of, 7 validation, 52f, 53
organizational excellence models. verification, 52f, 53
See quality award models, product development, 53, 94, 105
self-assessment

155
Index
product realization (clause 7), 24, 27f, quality management system (QMS),
50, 51f, 53–54, 94 future of
purpose, providing, 7 actions to consider from report
data for, 114–115
Q ASQ 2011 study on, 113–114,
QMS. See quality management 114f
system (QMS) communication challenge,
quality 108–112
business relationship of, 99–100 Conference Board and, 112–113,
ISO 9000:2005 definition of, 128 113t
working definition of, 128 cost optimization and, 118–119
quality assurance personnel customer relationships and,
executive management language 119–120
and, 100 global expansion and, 117–118
strategic planning and, 99 human capital and, 116–117
quality auditing. See auditing innovation and, 115–116
quality audits, internal, 33–34 overview, 107–108
quality award models, self- planning for, 112–120
assessment, 82–90 quality management system (QMS),
conducting phase tasks of, 84, 90 revitalization of
examples of, 82 changing conditions and, 93,
initiating, 83 124–127, 126f
maturity levels and, 85, 86t employee’s role and, 132–134
planning phase tasks of, 83 management review role and,
reporting phase tasks of, 84–85, 129–131
87–89, 89t people and, 127–129
step-by-step model of, 85–87 setting the bar and, 131–132
quality management principles shared vision and, 134–135
(QMPs), 6–10, 103 stable state and, 123–124
quality management system (QMS). quality professional
See also process management capabilities of, 101
auditing, 31–45 communication challenges of,
building, 19–30 108–112
creating sustainable, xv-xvi, xvif, concepts of, 102
5–12
current system, understanding, 5–6 R
future of (see quality management registration/regulatory compliance
system [QMS], future of) audits, 34
mission/vision statements and, resource management (clause 6), 24,
10–11 27f
processes for, 11–12 results, focus on, 7
quality management principles right-first-time (RFT), 61
and, 6–10
revitalization of (see quality S
management system [QMS], second-party audits, 31
revitalization of) sector-specific standards, auditing
structure and deployment of, 5–12 and, 42–43

156 Index
self-assessment systems approach to management,

conducting models for (see quality 69–74
award models, self-assessment) benefits of, 71–72
described, 36, 81–82 big-picture thinking techniques, 71
example, 85–87 complexity and, 72–73
intent of, 36–37 described, 69–70
vs. internal auditing, 36–38, 81 processes and, 70–71
ISO 9004:2009, questions for simplicity, steps to encourage,
planning/conducting, 139–150 73–74
literature on, 37
maturity levels and, 85, 86t T
output of, 81–82 tactical self-assessment examples,
questions asked and investigated 92–98
in, 90–92 third-party audits, 31
reports, 87–88, 89t total quality management (TQM), 97
strategic examples of, 98–104
tactical examples of, 92–98 U
setting the bar, quality management
Unlocking the Power of Your QMS:
Keys to Business Performance
shared vision, quality management
Improvement (West and
Cianfrani), xv, 8
Shingo, Shigeo, 58
Six Sigma, 97
V
T
social responsibility, 6–7, 28
stable state, quality management value stream mapping, 102–103 w
system and, 123–124 vision, providing, 7
stakeholder development, 8 vision statements
statistical process control (SPC), 97 alignment and, 67–69
strategic self-assessment examples, revising, 10–11
98–104
supplier audits, 34 W
supplier development, 8 workforce competence, 28
A
sustaining growth, considerations for,
126f
U
a

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ISO 9001:2008

H1446_Cianfrani_pi_000.indd 1 11/2/13 11:33 AM

ISO 9001:2008 Explained, Third Edition

To request a complimentary catalog of ASQ Quality Press publications, call

H1446_Cianfrani_pi_000.indd 2 11/5/13 9:53 AM

ASQ Quality Press

H1446_Cianfrani_pi_000.indd 3 11/2/13 11:33 AM

Printed on acid-free paper

H1446_Cianfrani_pi_000.indd 4 11/2/13 11:33 AM

List of Figures and Tables. . . . . . . . . . . . . . . . . . . . . . . . . ix

Chapter 1 Why Bother with Conformity?. . . . . . . . 1

Chapter 2 Building Your Quality Management

Chapter 3 Why Is Quality Auditing Important?. . . 31

H1446_Cianfrani_pi_000.indd 5 11/2/13 11:33 AM

The Distinction between Audit,

Chapter 4 What Is Needed to Be Successful. . . . . . 47

Chapter 5 Go Beyond Where It Matters. . . . . . . . . 81

H1446_Cianfrani_pi_000.indd 6 11/2/13 11:33 AM

Where Can ­Self-­Assessment Results

Chapter 6 Future Quality Management System

Chapter 7 Revitalizing Your Quality

H1446_Cianfrani_pi_000.indd 7 11/2/13 11:33 AM

Figure I.1 Model for the content of ISO 9001:2008

H1446_Cianfrani_pi_000.indd 9 11/2/13 11:33 AM

Figure 4.3 Appropriate attitudes and actions. . . . . . . . 61

H1446_Cianfrani_pi_000.indd 10 11/2/13 11:33 AM

H1446_Cianfrani_pi_160.indd 11 11/7/13 8:55 AM

such widespread recognition and use of this standard? Users

H1446_Cianfrani_pi_000.indd 12 11/2/13 11:33 AM

management will be a vital contributor to the sustainability of

H1446_Cianfrani_pi_000.indd 13 11/2/13 11:33 AM

H1446_Cianfrani_pi_160.indd 15 11/7/13 8:57 AM

ISO 9001 ISO 9001++ (6)

QMS elements What we need to do What we need to do

One of the pioneers of quality management and statistical

H1446_Cianfrani_pi_000.indd 16 11/2/13 11:33 AM

H1446_Cianfrani_pi_000.indd 1 11/2/13 11:40 AM

Leadership, planning, support,

Operational planning and control

Figure 1.1 Output matters.

In addition, it has become apparent that workers like ISO 9001

H1446_Cianfrani_pi_000.indd 2 11/2/13 11:40 AM

consistency in activities throughout the organization. Middle

H1446_Cianfrani_pi_000.indd 3 11/2/13 11:40 AM

be able to demonstrate conformity with ISO 9001 in order to

Why Should an Organization Want

H1446_Cianfrani_pi_000.indd 4 11/2/13 11:40 AM

• Existing and new competition can erode market share

Where and How to Start the Journey

Understand the State of the Current System

H1446_Cianfrani_pi_000.indd 5 11/2/13 11:40 AM

At one end of the maturity continuum is an organization

Understand the Quality Management Principles

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society at large may all have a stake in the organiza-

H1446_Cianfrani_pi_000.indd 7 11/2/13 11:40 AM

9. Manage with facts supported by credible data. Deci-

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So, where do top managers spend their time? In our experi-

H1446_Cianfrani_pi_000.indd 9 11/2/13 11:40 AM

contribute to improving operational excellence. Most CEOs

Quality professionals must learn to speak the

Create, Review, or Revise the Vision

Where Can Self-Assessment Results

Figure 2.1 P rocess: A set of interrelated or interacting activities that

Figure 2.2 Processes are supported by resources and controls.

Figure 2.4 A family of well-managed processes.

Figure 2.5 Process relationship of ISO 9001:2008 to ISO 9004:2009.