 ISO 9001

WHAT IS ISO 9001:2015 –

QUALITY MANAGEMENT
SYSTEMS?
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ISO 9001 is the international standard that specifies requirements for a quality management
system (QMS). Organizations use the standard to demonstrate the ability to consistently provide
products and services that meet customer and regulatory requirements. It is the most popular
standard in the ISO 9000 series and the only standard in the series to which organizations can
certify.

ISO 9001 was first published in 1987 by the International Organization for Standardization
(ISO), an international agency composed of the national standards bodies of more than 160
countries. The current version of ISO 9001 was released in September 2015.

Organizations certified to the ISO 9001:2008 standard will have a three-year period to transition
to ISO 9001:2015. When the transition period ends in September 2018, ISO 9001:2008
certificates will no longer be valid. Organizations looking to start their transition to the 2015
revision can purchase a copy of ISO 9001:2015.

Who should use the ISO 9001:2015 – quality management

systems revision?
 ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million
organizations from more than 160 countries have applied the ISO 9001 standard requirements to
their quality management systems. 

Organizations of all types and sizes find that using the ISO 9001 standard helps them: 

 Organize processes
 Improve the efficiency of processes
 Continually improve

All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as
possible. This includes not only organizations that are certified to ISO 9001:2008, but also any
organizations involved in training or certifying others.

Guidance on transitioning to ISO 9001:2015 can be downloaded from the International

Accreditation Forum (IAF).

What topics does ISO 9001:2015 cover?

ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented
approach to documenting and reviewing the structure, responsibilities, and procedures required
to achieve effective quality management in an organization. Specific sections of the standard
contain information on topics such as:

 Requirements for a quality management system, including documented information,

planning and determining process interactions
 Responsibilities of management
 Management of resources, including human resources and an organization’s work
environment  
 Product realization, including the steps from design to delivery
 Measurement, analysis, and improvement of the QMS through activities like internal
audits and corrective and preventive action

Looking for a longer introduction to the ISO 9001 standard and the process approach?
Read these popular open-access articles from QP magazine:  
     ISO 9001 Made Easy

ISO 9001 Made Easy

by Syed Hasan Jaffrey

ISO 9001 is a quality management system (QMS) standard that requires an organization to meet its own

requirements and those of its customers and regulators. It is based on the plan-do-check-act methodology, which

helps organizations establish, implement, monitor and measure their processes to deliver results that align with the

organization’s requirements and continually improve performance by taking appropriate action.

ISO 9001 is made up of eight sections: scope, normative reference, terms and definitions, quality management

system, management responsibility, resource management, product realization and measurement, analysis and

improvement.1The first three sections provide general information about the standard, and the last five focus on how

to implement it.
Section 1—scope: specifies that the organization needs to meet customer and regulatory requirements and

ensure its employees follow its policies and procedures while advancing quality through continual improvement.
Section 2—normative reference: provides normative references—those that conform to ISO 9000’s related

norms—to constitute the terms of ISO 9001.

Section 3—terms and definitions: defines the terms used in the standard and highlights the differences

between the 2000 version and the 1994 version.

Section 4—quality management system: describes the standard’s general requirements, which

encompass all activities from quality manual documentation and control of documents and records to determining the

sequence and interaction of the processes to implementing actions to achieve planned results.
Section 5—management responsibility: requires management’s commitment to the QMS and explains that

management must be dedicated to the organization’s products, customers and planning and review processes.
Section 6—resource management: provides the criteria needed to perform a job competently and in a safe

environment. Human resources, infrastructure planning and work environment are discussed in this section.
Section 7—product realization: defines the steps in product development. These steps include everything

from the initial design phase to the final delivery phase. For example: product realization planning, customer related

processes, design and development, the product purchasing process, production and service provisions and the

control of monitoring and measuring devices.

Section 8—measurement, analysis and improvement: focuses on measuring, analyzing and improving

the QMS by having companies perform periodical internal audits, monitor customer satisfaction, control

nonconforming product, analyze data and take corrective and preventive actions.

To ease implementation, ISO 9001 suggests companies adopt a process approach, which is a series of operations

that transform inputs into value added output (see Figure 1). A process can be measured by accuracy, timeliness,

cycle time, downtime, efficiency, effectiveness, turnaround and setup time.

Figure 1

Benefits

Of the many benefits of ISO 9001: 2000, these are the three most significant:

 It provides a framework for a well-organized QMS.

 It creates satisfied customers, management and employees.
 It helps companies continually improve.

ISO 9001:2000 certification authenticates the high quality standards of an organization. Besides benefiting the

employees, it also benefits the organization by organizing its processes. It not only gives flexible criteria, but also

allows an organization to monitor and increase the efficiency of its processes.

To achieve certification, a company must:

 Follow the guidelines of the ISO 9001 standard.

 Fulfill its own requirements and those of its customers.
 Follow statutory and regulatory requirements.
 Create documents.
 Keep track of records.

And always remember to say what you do and do what you say. In other words, be honest.

     The Process Approach to QMS in ISO 9001 and 9004

he Process Approach to QMS In ISO 9001 and ISO 9004

Revisions make the two standards more straightforward and applicable to all organizations

by Jeffrey H. Hooper

This article is adapted from chapter two of the new Quality Press ASQ ISO 9000 Handbook edited by Charles A.

Cianfrani, Joseph J. Tsiakals and John E. "Jack" West. West is a member of QP's regular panel of "Standards

Outlook" columnists. The handbook provides insight on each clause of ISO 9001:2000 by authors from around the

world who were involved in the process of writing the new standard. This article deals directly with the use of the

process approach. Other chapters in the handbook provide further insight into the use of the process approach in the

documentation of a quality management system and in continual improvement.

One of the most important aspects of the year 2000 revisions of ISO 9001 and ISO 9004 was the adoption of
the process approach to quality management systems (QMSs). A strong consensus for adopting the process

approach formed very early in the revision cycle.

This approach improves on that of the previous standard by providing a much more generic structure readily

applicable to all sectors of the economy and sizes of organization. At the same time, it allows the requirements to be

stated in language more familiar to line managers and less encumbered by quality jargon.

ISO 9001:2000 focuses on improving the effectiveness of a QMS to enhance customer satisfaction

by meeting customer requirements, while ISO 9004:2000 focuses on improving the effectiveness

and efficiency of a QMS to enhance interested party satisfaction by meeting interested party
requirements. The common structure of the two standards is demonstrated in Figure 1.

Understanding the approach

The process approach is one of the eight quality management principles upon which the entire ISO 9000 series of

standards is based. This principle says a desired result is achieved more efficiently when activities and related

resources are managed as a process.

The word "process" is defined in ISO 9000:2000 clause 3.4.1 as "a set of interrelated or interacting activities that

transforms inputs into outputs." Inputs to a process are generally outputs of other processes. Processes in an

organization are generally planned and carried out under controlled conditions to add value.

From the principle and process definition you can see the process approach is a powerful way of organizing and

managing how work activities create value. While a more traditional structure organizes and manages work activities

vertically by function, with quality problems frequently occurring at the boundaries of the functional departments, the

process approach organizes and manages work horizontally the way work activities create customer value.

The process approach directly links process inputs that come from suppliers to the outputs of the

process that go to customers. This horizontal linkage between suppliers and customers is an

excellent way to manage and continually improve both the effectiveness (the amount of value created for the
customers) and the efficiency of the process (the amount of resources consumed). Figure 2 (p. 72) shows these

relationships.

Methodology

Once the processes needed for the QMS and their sequences and interactions have been identified (see Figure 1),

it is necessary to establish management responsibilities and accountabilities for the performance of these processes.

Many methodologies are available for managing and improving processes, but all share some simple basic elements.

A simple process management and improvement methodology organized in a series of steps is described in the

following:

Step one: Establish the responsibilities for managing the process. It is critical to have an overall process

manager or process owner with end to end responsibility and accountability for all aspects of process performance.

The process manager needs to understand the entire process and have the authority to effect changes in any part of

it.

The process manager is responsible for the following:

 Forming the process management team, which includes representatives from each major part
of the process.
 Ensuring the process operates in a controlled state of predictable performance.
 Establishing process performance measures that adequately characterize the efficiency and
effectiveness of the process in meeting the needs of all customers and other interested parties.
 Ensuring all aspects of process management and improvement are performed. This includes
creating documentation, tracking performance, and securing and allocating resources.
Step two: Define the process. The process manager and process management team need to carefully define the

process so everyone working within the process has a shared understanding of how it operates. How much

documentation is required depends on such attributes as the stability and education of the workforce and the

complexity and criticality of the process.

All process inputs and outputs are identified, along with the suppliers and customers, who may be internal or external.

The team also identifies process steps and flows. Many quality tools, such as block diagrams and flowcharts, are

available to support these activities.

Step three: Identify customer requirements. Carefully gather, analyze and document customer needs, including

how customers use the outputs of the process. Communicate frequently with customers to understand needs from

their viewpoint.

To the extent possible, define measurable customer needs and rank them in order of importance. Directly validate

needs and requirements with customers.

Step four: Establish measures of process performance. Translate customer needs and requirements into

measures of process performance. This is one of the most important and difficult steps in process management.

Include customer satisfaction, in-process measures and measures of supplier performance in process measures.

Relate all important customer needs, such as on time performance, defect or error rates, tolerance intervals, product

reusability, and worker health and safety, to performance measures.

The process approach is therefore one of the strongest approaches for integrating management system standards

because each process must be managed and improved simultaneously for all process performance measures.

Directly linking process performance measures with customer needs is one of the most powerful aspects of process

management.

Step five: Compare process performance with customer requirements. Use the process performance measures

to ensure your process is operating in a stable and predictable manner.

Compare the process performance measures with the needs and requirements of the customers. Use a variety of

statistical tools for analyzing process measurement data to help quantify process performance. Identify critical

process improvement opportunities through gaps in process performance.

These first five steps provide a basic methodology for process management. But the responsibilities of the process

manager and process management team do not end there. A significant benefit of process management is its natural

fit with process improvement. Once process performance has been compared with customer requirements, process

improvement is the natural next step.

Step six: Identify process improvement opportunities. Use gaps in process performance vs. customer needs to

determine critical process improvement opportunities. Analyze process performance measures for improvement

opportunities related to sources of such attributes as errors and defects, process simplification opportunities, process

bottlenecks and lack of adequate process controls.

Both process effectiveness and efficiency can improve as a result of process improvement activities. Many tools exist

to identify process improvement opportunities.

Once process improvement opportunities are identified, any of the many quality improvement methods can be used

to improve process performance. These quality improvement methods fit naturally into step seven of the process

management and improvement methodology.

One quality improvement method that can be used at this step is the plan, do, check, act (PDCA) cycle.

Step seven: Improve process performance. Select the process improvement opportunity to pursue. This selection

should take into account such attributes as the criticality of certain improvement needs, difficulty of improvement

opportunities, and resources and expertise available.

Establish quality improvement teams to pursue specific improvement opportunities. These teams are established by

the process manager and process management team. The quality improvement teams report to the process manager

or the process management team and are typically disbanded once their improvement project is completed.

The quality improvement teams complete the following activities:

 Clarify the improvement opportunity problem statement, schedule and budget.

 Determine the root causes of problems.
 Develop and implement countermeasures to reduce or eliminate the occurrence of root
causes.
 Stabilize the process at the new level of performance.
 Return to step six or seven.

Support for the system approach

The process approach is an important part of the system approach to management. The process approach assumes

understanding and managing interrelated processes as a system can contribute to an organization's effectiveness

and efficiency in achieving objectives.

Using the process approach, a QMS is comprised of the following four categories of interrelated processes (shown
in Figure 1, p. 70):
 Management responsibility.
 Resource management.
 Product realization.
 Measurement, analysis and improvement.
 Each process can be managed and improved using process management and improvement methodology, but

managing the interrelated processes as a system introduces additional improvement opportunities.

First, processes can be analyzed and improved together as mega-processes, increasing the opportunities for

improvement. But you can also directly pursue improvement of the entire QMS using audit and self-assessment

(using 9004:2000 or quality award criteria) results and the PDCA cycle.

The multiple levels at which continual improvement occurs make QMSs based on the process approach a powerful

way to manage organizations toward achieving performance excellence.

Changes introduced in the 2015 revision are intended to ensure that ISO 9001 continues to adapt
to the changing environments in which organizations operate. Some of the key updates in ISO
9001:2015 include the introduction of new terminology, restructuring some of the information,
an emphasis on risk-based thinking to enhance the application of the process approach, improved
applicability for services, and increased leadership requirements.  

See a collection of featured resources providing more details on ISO 9001, including materials
you can use to prepare for the transition to ISO 9001:2015.

How do I get started with ISO 9001:2015?

Organizations and individuals that use ISO 9001 are encouraged to transition to the 2015
revision as soon as possible. However, the International Accreditation Forum (IAF) and the ISO
Committee on Conformity Assessment (CASCO) have agreed to a three-year transition period
from the publication date of ISO 9001:2015.

Whether you are beginning your ISO 9001 journey or transitioning to the 2015 revision, your
first step is to purchase a copy of ISO 9001:2015.

What are the benefits of ISO 9001?

ISO 9001 helps organizations ensure their customers consistently receive high quality products
and services, which in turn brings many benefits, including satisfied customers, management,
and employees.

Because ISO 9001 specifies the requirements for an effective quality management system,
organizations find that using the standard helps them: 

 Organize a QMS
 Create satisfied customers, management, and employees
 Continually improve
 "It has been my experience, with several companies, that the culture change associated with ISO
implementation is multilayered. The first and most obvious benefit is quality awareness," ASQ
senior member Bud Salsbury writes on ASQ’s Ask the Experts blog. "This quality awareness
does not fade away easily. Even those who offer strong resistance to change learn to respect and
very much appreciate all the practical value in a good quality management system."

ISO 9001 also provides financial benefits, such as cost savings.

In Nevada, the Clark County School District used ISO 9001 to save $174 million over 10 years
in actual expenditures and cost avoidance. More than 3,000 employees were trained to the
standard, enabling three critical components of the system’s success: training, communication
and respect, and efficiency.

Read other ISO 9001 case studies to see the performance benefits of using the standard.

ISO 9001:2015 as a “business management tool”

In an article for ASQ’s QP magazine, Oscar Combs summarizes results of a Harvard Business
School study comparing 916 organizations that have adopted ISO 9001 and 17,849 non-adopters.
As Combs explains, the “business benefits” enjoyed by the ISO 9001 organizations included
higher rates of survival and growth, increased wages, reduced waste, enhanced productivity, and
improved health and safety performance.

“ISO 9001 offers more than quality benefits. The standard should be thought of as a business management tool an organization
can use to drive value, improve its operations and reduce its risks.”

- Oscar Combs, Standard Wise

Achieving ISO 9001 certification

ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify.
Achieving certification means that an organization has demonstrated the following:

 Follows the guidelines of the ISO 9001 standard

 Fulfills its own requirements
 Meets customer requirements and statutory and regulatory requirements
 Maintains documentation

Certification to the ISO 9001 standard can enhance an organization’s credibility by showing
customers that its products and services meet expectations. In some instances or in some
industries, certification is required or legally mandated.

The certification process includes implementing the requirements of ISO 9001:2015 and then
completing a successful registrar’s audit confirming the organization meets those requirements.
 As Bill Aston explains in an Expert Answers column for ASQ’s QP magazine, organizations
should consider the following as they begin preparing for an ISO 9001 quality management
system certification:

 Registrar’s costs for ISO 9001 registration, surveillance and recertification audits
 Current level of conformance with ISO 9001 requirements
 Amount of resources that the company will dedicate to this project for development and
implementation
 Amount of support that will be required from a consultant and the associated costs

Read "What’s the cost?" for a checklist you can use to assess the costs of certifying to ISO 9001.

ASQ does not issue ISO 9001 certification.

"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."

- Charles A. Cianfrani and John E. "Jack" West, ISO 9001:2008 Explained & Expanded

Training in the ISO 9001 standard

Training can provide an opportunity to review the ISO 9001:2015 standard and apply quality
management principles in a practice environment.

Professionals responsible for developing, implementing, auditing, and managing an ISO quality
management system or quality professionals interested in updating their documented ISO 9001-
based QMS can take ISO 9000 training courses, which include courses focused on ISO 9001 and
quality management systems. Additionally, organizations looking to improve employee
performance and employees looking to continually improve will also find ISO 9000 training
relevant.

Previous versions of ISO 9001

Originally published in 1987, ISO 9001 underwent revisions in 1994, 2000 and again in 2008.
The latest revision was published in September 2015.

As John E. "Jack" West, Lorri Hunt, Nigel H. Croft, and Alka Jarvis write in an article
for QP magazine:

 ISO 9001:1994 included changes to significantly improve the clause on control of design
and development, and to provide several other clarifications. The 1994 series also slightly
modified the role of ISO 9002 and 9003….
 The ISO 9001:2008 revision can be thought of as an amendment to clarify issues that had
been raised during the application of ISO 9001:2000. It included several changes to the text but no
additional requirements.
Read an article in ASQ’s QP magazine for details on the changes that took effect in the revision
from ISO 9001:2008 to ISO 9001:2015.

Why did you look up ISO 9001:2015?

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