STANDARDS OUTLOOK BY JOHN E.

“JACK” WEST
AND CHARLES A. CIANFRANI

Managing the System

Revision introduces focus on organizational operating conditions
AS ORGANIZATIONS begin to review
the draft international standard (DIS) of
ISO 9001:2015, they will notice a number
of language changes. The question that
comes to mind first is: Do the new words
imply new or different requirements, or
are they just repackaging of the same
requirements? Surely, there must be some
of each.
It can be argued that if an organization
properly interpreted and implemented ISO
9001:2008, the changes in the 2015 version
should have minimum impact. There is an
apparent difference in focus in the DIS,
however. Clause 4 of the draft introduces
what seems to be a new concept, “context
of the organization,” which focuses on
understanding the organization’s operating
conditions. The DIS includes four
subclauses that elaborate on this concept.
This article explores clause 4 of the
ISO 9001:2015 DIS. The bolded statements
throughout the article signify takeaway
points that may be helpful for organiza-
tions preparing for the transition to the
revised standard.
can perhaps be viewed as a significant
advancement in thinking.
Clause 4.1 requires the organization
to: “… determine external and internal
issues that are relevant to its purpose and
its strategic direction and that affect its
ability to achieve the intended result(s) of
its quality management system.” 1
The requirement is to determine
internal and external issues but to
accomplish that in a useful way, an
organization must first understand its
strategic direction.
It is amazing how many organizations
have a fluid set of uncoordinated strate-
gies without a clear direction. There are
always issues that will affect the strategic
direction of any organization. Those issues
must be determined, and knowledge about
them must be used in planning. Some, or
perhaps most, of these issues will affect the
effectiveness and efficiency of the quality
management system (QMS), so understand-
ing them is potentially a great input to QMS
development.
Earlier versions of ISO 9001
hardly hinted at these ideas. An issue
organizations will face with the DIS’s
wording of clause 4.1 is how far they
should go when determining “… external
and internal issues that are relevant to
its purpose and its strategic direction
and that affect its ability to achieve the
intended result(s).”
Keep in mind: It is the
organization’s responsibility and
prerogative to make such decisions—
not external auditors.
The title of clause 4.2 introduces
two more terms that are new to ISO
9001: understanding the “needs and
expectations” of “interested parties.”2
Earlier versions of ISO 9001 did require
identification of customer requirements
but did not use the terms “interested
parties” or “needs and expectations.”

Context of the organization

The notion behind “context of the
organization” is that an organization
must fully explore and understand the
internal and external conditions under
which it operates. This is like a football
team understanding the rules of the game,
the nature of the playing field, and the
strengths and weaknesses of its own team
and the competition.
It is a simple concept, but in reality, it is
an ongoing enterprise challenge. In today’s
world, organizations must understand
the changes that occur all around them.
Formal recognition of this need in the DIS

August 2014 • QP 53
 STANDARDS OUTLOOK
The text of 4.2 makes it clear the intent
is to determine the interested parties and
requirements that are relevant to the QMS.
The organization must determine which
interested parties are relevant and which
of their requirements are relevant.
In most cases, the needs and expectations
of customers are most important, but other
interested parties might include regulatory
agencies, suppliers and even society
in general, especially if environmental
implications are related to the realization or
use of an organization’s products.
In any case, it is best to keep the
customer in mind. In the Annex B listing
of quality management principles (QMP),
the first principle listed is customer focus:
• Statement: The primary focus of qual-
ity management is to meet customer
requirements and to strive to exceed
customer expectations.
• Rationale: Sustained success is
achieved when an organization at-
tracts and retains the confidence of
customers and other interested parties
on whom it depends. Every aspect
of customer interaction provides an
opportunity to create more value for
the customer. Understanding current
and future needs of customers and
other interested parties contributes to
sustained success of an organization.
Remember also that the scope of the
DIS is focused on consistently meeting
customer and regulatory requirements
and system improvement. Don’t let
the expanded concepts of the new
revision divert primary attention away
from customers. It is ultimately the
organization that decides who to
include as interested parties.
Leadership
It is noteworthy that current and earlier
versions of ISO 9001 avoided using the
term “leadership,” perhaps, because for
many organizations, it has something of a
soft feel to it. The DIS for ISO 9001:2015
54 QP • www.qualityprogress.com
no longer avoids the word, however.
While the draft does continue to use
terms such as “top management,” empha-
sis has shifted to demonstration of leader-
ship. Leadership is another of the seven
QMPs given in Annex B of the DIS:
• Statement: Leaders at all levels estab-
lish unity of purpose and direction, and
create conditions in which people are
engaged in achieving the quality objec-
tives of the organization.
• Rationale: Creation of unity of pur-
pose, direction and engagement enable
an organization to align its strategies,
policies, processes and resources to
achieve its objectives.
What is required to demonstrate
leadership? Top managers should
refer to an extensive list of 11
requirements in clause 5.1.1. The
list includes promoting activities such
as the process approach, continual
improvement, setting objectives and being
accountable for system effectiveness.3
Process approach and the system
The use of the process approach in
developing and modifying QMSs has
become quite common. The fourth QMP
addresses this subject:
• Statement: Consistent and predictable
results are achieved more effectively
and efficiently when activities are un-
derstood and managed as interrelated
processes that function as a coherent
system.
• Rationale: The QMS is composed of
interrelated processes. Understanding
how results are produced by this system,
including all its processes, resources,
controls and interactions, allows the
organization to optimize its performance.
As did ISO 9001:2000 and 2008, the
DIS continues to require organizations
to do some specific things related to
the processes of their QMS. They must
identify the system’s processes and their
interactions, and the resources required
to operate, control, monitor, measure and
continually improve those processes.
Too often, processes are well defined,
documented and run for years without any
real improvement or change. When this
happens, the organization is in danger of
losing its competitiveness over time.
One reason this happens is managers
fail to fully appreciate the roles of people
who work in the processes. Also under-
addressed is the requirement to continual-
ly manage measurement, analysis of data
and improvement of processes.
Used properly, the process approach
can lead to quality excellence. The key
here is the word “manage.” In the past,
organizations often used flowcharts to
understand their processes but had not
really defined how processes would
be managed, controlled, monitored,
measured and improved.
Flowcharts alone do not do all of these
things. Processes are the way things get
done. They are the way transformations
take place to add value. They are also the
way work is stabilized, controlled and
made consistent. Process management is
the first prerequisite to reducing variation.
When it is effectively implemented, pro-
cess management can be a large contribu-
tor to improved quality and productivity.
Some might argue that managing process-
es is the most important thing managers
do, but that is not completely correct.
Are processes more important than
people? Ultimately, an organization
is nothing but processes and their
associated resources. People are one of
those resources, making people sound
somewhat unimportant.
Is it reality, however, to expect pro-
cesses to be defined by bosses who think
of the people who work in the process
as just another resource? Is managing
processes more important than leading
people? After all, it is people who create,
monitor, measure, control and improve
the processes of an organization.
 Because it is the people who make pro-
cesses work and determine how well they
work, it is critical to get the people who
work in processes fully engaged in their
work and to involve them in the process
management activities for improvement.
Competent and trained people who work
with the processes every day are best able
to manage them. Involving these people
in process development, understanding,
measurement and improvement is a key to
successful process management.
People who work in the process should
talk to the process customers to identify
the process outputs, get agreements on
what to measure and how, and set targets
for those outputs.
Likewise, they should talk to the
suppliers of the process to define what
the process needs in terms of inputs to
determine how these inputs should be
measured and to set targets for them.
Qualitative and quantitative customer
feedback should be solicited.
The attitude that “the workers work in
the process, and the managers work on
the process” must change. It is the people
who work most closely with a process
who can often do the best job of analyz-
ing process activities to find duplicative
or nonvalue-adding activities that can be
combined or eliminated. These people can
be great at eliminating waste.
If working on the processes should be
the job of those who operate the processes,
what do individuals such as managers,
process engineers and quality engineers do?
• They promote, educate and monitor.
• They ensure people are working on the
right process improvements.
• They demonstrate their leadership by
constantly communicating the objec-
tives and progress being made.
• They create and maintain the internal
environment in which people can
become fully involved in achieving the
organization’s objectives.4
The involvement of people principle is
stated in the third QMP:
• Statement: It is essential for the orga-
nization that all people are competent,
empowered and engaged in delivering
value. Competent, empowered and en-
gaged people throughout the organiza-
tion enhance its ability to create value.
• Rationale: To manage an organization
effectively and efficiently, it is impor-
tant to involve all people at all levels
and to respect them as individuals. Rec-
ognition, empowerment and enhance-
ment of skills and knowledge facilitate
Competent and trained people
who work with the processes
every day are best able to
manage them.
the engagement of people in achieving
the objectives of the organization.
Good leaders encourage participa-
tion and innovation. They make certain
everyone is engaged in their work and
involved in improvement. They must listen
and consider innovative new ideas. Good
leaders must ensure good ideas are fo-
cused on organizational objectives so
objectives are developed into process
changes that improve efficiency and
effectiveness.
In the ideal process, a small number of
independent variables can be measured
and controlled to control the behavior of
outputs (response variables).
Managing the process interactions is
different for at least two reasons. First,
process interactions are where problems
seem to manifest themselves. Then there
is the issue of complexity. Complexity
increases as the number of process inter-
actions increases.
The number of interactions increases
faster than the number of processes.
If there are three processes and each
interacts with the others, there are three
possible interactions among them. If there
are four processes, there are six possible
interactions. With five processes, there are
10 interactions, and it can go on. There also
are often multiple interactions between any
two processes. It can get messy 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 of
the system, and those consequences often
happen long after the action was taken.
Here’s a possible example: A quality
improvement proposal was resisted by
the system but eventually turned into cost
reductions that helped make last year’s
financial goals. But the resulting rise in
this year’s warranty costs are blamed on
you for “not controlling the parts.”
In this example, various parts of the
management system reacted in different
and unexpected ways. You proposed an
improvement in quality, but the finance
people thought it too expensive. The
design and industrial engineers got
together and came up with an alternative
that reduced cost but had significant risk.
Somehow, you were not involved in the
final solution. The cost reduction part of
the story is long forgotten, but the system
tracked the item as your idea.
The point is that if the managers in
this little situation saw the business as a
system, they would look for the best overall
results—not just grab the quick money and
hope there is no problem in the future.
August 2014 • QP 55
 STANDARDS OUTLOOK
When there is a focus on processes,
there’s a tendency to focus on the details.
It’s important to understand how
the entire system works, rather than
search only for direct cause-and-effect
relationships.
In leading all employees to make
improvements, managers must understand
what will happen if they make a process
change that is not properly coordinated.
People in a process usually have difficulty
developing a big-picture understanding,
but big-picture coordination makes
system management work.
In the example, the interrelation-
ship among the cost reduction, quality
improvement and financial accounting
processes needed attention.
Some things that can help with big-
picture thinking include:
• When people work on improving one
process, it is the job of the managers to
make certain the other processes and
interactions are considered.
• Think globally and understand how the
various processes of the system work
together to achieve the organization’s
objectives. An organization has only one
management system, but that system
may have many components. It may
include processes to manage aspects
such as finance, investor relations and
quality. All parts of the system must
work together to produce results.
• Perform rigorous design review by
all who are or can be affected when
contemplating changes to processes
and products.
All these activities take time and skill-
ful leadership. Many managers are more
comfortable doing the actual improvement
work themselves. Solving problems and
making improvements is the real fun part
of their jobs. The key is that leadership
must be focused on involving everyone.
Managers must learn that it is even
more fun to see their team members
successfully implement real innovative
56 QP • www.qualityprogress.com
Foundation of a QMS
Quality management system (QMS)
Mission
Vision
Values/principles
Strategies
(strategic plan)
Quality and business objectives, mission and vision
changes that make the organization better.
The people make all the difference.
Fundamental need for alignment
As an organization assesses and decides
how to address concepts such as the “con-
text of the organization” and the “needs
and expectations of interested parties” in
its QMS requirements, it is concomitantly
imperative to integrate such requirements
into the mission, vision and strategic plans
of the organization.
Figure 1 illustrates how the QMS is
built on the vision, mission and objectives
of the organization, and the QMS must
not only be compatible with these items,
but also support the achievement of them.
The QMS will only be credible if it is
a vital element of and contributor to
the achievement of the vision, mission
and objectives of the organization.
Careful considerations
This column has just scratched the
surface of the meaning and intent of a
few of the concepts incorporated into DIS
ISO 9001:2015. For some organizations,
the new content will be viewed as a mere
distinction from the requirements in the
2008 edition of ISO 9001. For others, it will
require thoughtful attention.
Organizations should carefully consider
the words of the DIS and, more impor-
/ FIGURE 1
Quality policy
tantly, the intent of the words. Most criti-
cal, however, is to consider implementing
improvements to processes that will
effectively contribute to the achievement
of the vision, mission and objectives of the
organization.
A QMS is not just for quality. It is a vital
and integral element of the management
of an organization. QP
REFERENCES AND NOTE
1. International Organization for Standardization, Draft
International Standard ISO 9001:2015, Clause 4.1—
Understanding the organization and its context.
2. International Organization for Standardization, Draft
International Standard ISO 9001:2015, Clause 4.2—
Understanding the needs and expectations of interested
parties.
3. International Organization for Standardization, Draft
International Standard ISO 9001:2015, Clause 5.1.1—
Leadership and commitment with respect to QMS.
4. Ibid. See leadership and commitment among the 11 items
listed in clause 5.1.1.
JOHN E. “JACK” WEST is a member
of Silver Fox Advisors in Houston.
He is past chair of the U.S. Technical
Advisory Group to the International
Organization for Standardization
Technical Committee 176 (ISO/TC 176)
and lead delegate of the committee
responsible for the ISO 9000 family of
quality management system standards. He is an ASQ fellow
and has co-authored several ASQ Quality Press books.
CHARLES A. CIANFRANI is a principal
consultant for Green Lane Quality
Management Services in Green Lane,
PA. He is a U.S. expert representative
to ISO/TC 176. He has an MBA from
Drexel University and a master’s
degree in applied statistics from
Villanova University. An ASQ fellow,
Cianfrani is a certified quality engineer, reliability engineer
and auditor, as well as an Exemplar Global-certified quality
management systems auditor.
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