CBM 131 Operations Management and Total Quality Management

Lesson 14 ISO 9000 and the Total Quality: The Relationship

14.1 ISO 9000: THE INTERNATIONAL STANDARD

FOR QUALITY MANAGEMENT SYSTEMS

ISO 9000 is a family of standards and guidelines related to the quality management system (QMS). It sets the requirements
for the assurance of quality and for management’s involvement. The thrust of ISO 9000 is for organizations to implement a
QMS conforming to the standard’s requirements and, through the consistent, rigorous employment of the QMS, to

■■ Improve customer satisfaction by fulfilling customer requirements;

■■ Achieve continual improvement of organizational performance and competitiveness;
■■ Continually improve its processes, products, and services; and
■■ Comply with regulatory requirements.

It is important to note that ISO 9000 does not specify a level of quality or performance for any product or service provided by
an organization. That is left to the organization to determine with its customers. ISO 9000 is about standardizing the
approach organizations everywhere use to manage and improve the processes that ultimately result in their products and
services. ISO 9000 is applicable to any organization, whether in the private or the public sector, whether large or small, and
applies to those components of the organization that can have an impact on product or service quality. These typically
include the departments responsible for engineering/design, purchasing, manufacturing, quality assurance, and delivery of
the organization’s products and services.

When an organization demonstrates conformity to ISO 9001 to an independent (third party) registrar firm, the registrar can
certify (or register) the organization. Registration provides assurance to customers worldwide that products or services from
the organization can be expected to consistently meet customer requirements. To maintain its registration, the organization
must constantly strive to ensure that the QMS continues to function effectively and that it is continually improved. That is
done through consistent and rigorous application of the QMS and a system of formal, documented internal audits in
interaction with the organization’s top management, interspersed with periodic independent audits by the registrar
firm. Registration may be lost if the registrar’s audits determine that the organization is not conforming to the requirements of
its registered QMS.

The Eight Principles: ISO 9000’s Basis

ISO 9000 QMS is based on eight principles from total quality management (TQM):

1. Understand the customer’s needs, meet the customer’s requirements, and strive to exceed the customer’s
expectations.
2. Establish unity of purpose and organizational direction and provide an environment that promotes employee involvement
and achievement of objectives.
3. Take advantage of fully involved employees, using all their abilities for the benefit of the organization.
4. Recognize that things accomplished are the results of processes and that processes along with related activities and
resources must be managed.
5. The multiple interrelated processes that contribute to the organization’s effectiveness are a system and should be
managed as a system.
6. Continual improvement should be a permanent objective applied to the organization and to its people, processes,
systems, and products.
7. Decisions must be based on the analysis of accurate, relevant, and reliable data and information.
8. Both the organization and the supplier benefiting from one another’s resources and knowledge results in value for all.
1
Page
 CBM 131 Operations Management and Total Quality Management

Plan–Do–Check–Act: ISO 9000’s Operating Principle

Plan–Do–Check–Act is now the operating principle of ISO’s management system standards. Its function is to operate
in a never-ending loop, as described in the following steps and shown in Figure 14.1, resulting in continual improvement
for products/services, processes, and systems of processes.

1. Plan. Establish objectives and develop the plans to achieve them.

2. Do. Put the plans into action.
3. Check. Measure the results of the action; that is, is the planned action working, or were the objectives met?
4. Act (or Adjust). Learn from the results of the third (Check) step, make any necessary changes to the plans,
and repeat the cycle.

14.2 HOW ISO 9000 IS APPLIED TO ORGANIZATIONS

No organization is required by any government to use ISO 9000. Some government and corporate customers may well
require their suppliers to be ISO 9000 registered (or at least conforming), but usually whether to adopt the ISO 9000 QMS is
strictly up to the organization’s management. Once management decides to go with ISO 9000, then it is faced with the task
of developing its QMS to conform to the requirements of ISO 9001. ISO 9001 lays down the requirements for what an
organization’s QMS must do but does not dictate how the QMS should do it in any particular organization. The organization
determines that for itself and, if seeking registration, employs an accredited registrar firm to verify its conformance to ISO
9001. The organization, once registered, must

■■ Apply its QMS to its operations according to the standard and exactly as the QMS states.
■■ Continually assess the effectiveness of the QMS and make changes to improve it.
■■ Conduct periodic internal QMS audits.
■■ Submit to external (third party) surveillance audits at least annually by its registrar.
■■ Submit to a new registration audit every third year by a registrar.

As mentioned earlier, customer requirements for their suppliers to be registered to ISO 9001 have become widespread
in several industrial sectors. Several global business sectors have adopted ISO 9001 as the basis for quality management
systems mandated throughout their supply chains. Each sector has adapted the standard to its unique requirements and
renamed the standard accordingly. Organizations in the concerned industrial sectors are required to operate under these
tailored standards.

14.3 ISO 9000 QUALITY MANAGEMENT SYSTEM: A DEFINITION

To secure registration, organizations must develop and use quality management systems conforming to the requirements
of ISO 9001. The first question asked by someone unfamiliar with ISO 9000 is “What is a quality management
2

system?” We provide the following definition:

Page
 CBM 131 Operations Management and Total Quality Management

The quality management system is composed of all the organization’s policies, procedures, plans,
resources, processes, and delineation of responsibility and authority, all deliberately aimed at
achieving product or service quality levels consistent with customer satisfaction and the organization’s
objectives. When these policies, procedures, plans, and so forth are taken together, they define how
the organization works and how quality is managed.

The quality management system will include this documentation:

1. A quality policy. This statement describes how the organization approaches quality.
2. The quality manual. This must address each clause of the ISO 9001 standard. It will also typically include an organization
chart, or some such device, illustrating management responsibility for operating the quality system. Quality procedures may
be part of this manual, or they may be referenced.
3. Quality objectives. These are the goals related to quality and must be in harmony with the quality policy. Quality
objectives are assigned to the relevant organizational functions and levels and are tracked by top management.
4. Quality procedures. These describe step by step what the company does to meet the quality policy. As a minimum, there
will be a procedure for each of the ISO 9001 clauses outlining requirements. There may also be procedures for any
processes that can impact quality.
5. Forms, records, and so on. These provide proof of activities for the firm and for the auditors.

This documentation is used to ensure the necessary consistency in the firm’s operations and processes. Auditors use it
to verify conformance.

14.4 AUTHORITY FOR CERTIFICATION/REGISTRATION

When an organization says it is certified or registered to ISO 9001, one

may ask, “By what authority?” You understand by now that registration
(or certification—they are synonymous, with registration more commonly
used in the United States) is awarded by a registrar firm. These firms,
sometimes referred to as certification bodies, are almost always private
companies that have auditing expertise. Well, then, who gives them the
authority to grant ISO 9000 registration certificates? How do we know
that they are competent to determine which organizations get registered
and which do not? The answer is that all certification bodies for ISO 9000
must themselves be accredited by a higher level group called—you
guessed it—an accreditation body. There are lots of certification bodies
(the registrars) but far fewer accreditation bodies. Now one would think
that the authority of the accreditation bodies must emanate from the
International Organization for Standardization (ISO), but that is not the
case. There is another level of oversight connected with ISO conformity
assessment: the International Accreditation Forum (IAF), made up of
accreditation bodies, industry representatives, and other stakeholders.
Members of the IAF are required to give assurance that they will comply
with the international standards and IAF guidance. The IAF takes its
authority from Article 6 of the World Trade Organization’s Agreement on
Technical Barriers to Trade, which stated the need for bodies involved in
conformity assessments (i.e., the registrars) to be proven technically
competent through a process of accreditation. The flow of certification authority from the IAF to the registrar is shown in
Figure 14.2.
3
Page
 CBM 131 Operations Management and Total Quality Management

14.5 ISO 9001 AND INDUSTRY-SPECIFIC APPLICATIONS

ISO 9001 standard is intentionally generic so that it can be applied to any given organization, public or private. However,
selected industries have found it helpful to tailor ISO 9001 standard specifically for their use. The benefits of developing
industry-specific versions of the ISO 9001 standard are that it encourages: (1) the training and deployment of auditors with
industry-specific knowledge rather than ISO 9000 generalists and (2) a more accurate interpretation of the standard for a
given industry. The most widely used industry-specific applications of ISO 9001 are as follows:

■■ TickIT. Developed by the United Kingdom’s Board of Trade specifically for the information technology industry.
■■ AS 9000. Developed specifically for the aerospace industry.
■■ PS 9000. Developed specifically for the pharmaceutical packaging materials industry.
■■ ISO/TS 16949. Developed specifically for the automotive industry (replaced QS 9000, an earlier version).
■■ TL 9000. Developed specifically for the telecommunications industry.
■■ ISO 13485. Developed specifically for the medical industry.
■■ ISO/TS 29001. Developed specifically for the petroleum, petrochemical, and natural gas industries.

14.6 ORGANIZATIONAL REGISTRATION TO ISO 9001

Whether an organization manufactures a product or provides a service, whether it is a company or a governmental agency,
whether it is large or small, ISO 9000 can apply and be used to advantage. There is nothing to prevent an organization from
implementing and using a conforming QMS without going through the rigors and expense of actually registering. However,
without being registered, credibility becomes an issue. The results could conceivably be the same, whether registered or
not—except for a couple of factors. The organization that is registered by a recognized certification body will have more
credibility in the world’s marketplace, something that may be crucially important.

Either way, the organization that wants a conforming ISO 9000 QMS must go through a process that includes the following
steps (steps 5 and 7 are omitted for nonregistering organizations):

1. Develop (or upgrade) a quality manual that describes how the organization will assure the quality of its products or
services.
2. Document procedures (or upgrade existing documentation) that describe how the various processes for design,
production, continual improvement, and so on will be operated. This must include procedures for management reviews and
audits.
3. The organization must secure (and provide evidence of, if registering) top management’s commitment to the QMS and
continual improvement.
4. The organization’s top management must ensure that customer requirements are determined and met.
5. If registering, the organization must hire an accredited registrar company to examine its systems, processes, procedures,
quality manual, records, and related items. If everything is in order and if the registrar is satisfied that the organization is
effectively using the QMS, registration will be granted.
6. Whether registered or not, the organization must conduct its own internal audits to ensure that the systems, processes,
and procedures are working effectively.
7. Once registered, the outside registrar will make periodic audits for the same purpose. These audits must be passed to
retain registration.

An important point to remember about ISO 9000 is that the organization has to respond to all ISO 9001 requirements and tell
the registrar specifically what it is going to do and how it is to be done. ISO does not tell the organization what it must do or
how to do it. To retain registration, the organization must do what it said it would do.
4
Page
 CBM 131 Operations Management and Total Quality Management

14.7 THE BENEFITS OF ISO 9000

Organizational Benefits

ISO claims that beyond customer satisfaction, cost and risk management benefits will also accrue to the organization. These
benefits translate to improved competitiveness—the same as TQM’s objective. ISO claims these benefits result from
emphasizing the eight quality management principles on which the standard is based.

Customer Benefits

Customers want products or services that meet their requirements, and they want them at a competitive price. Like TQM,
ISO 9000 can help the organization in both areas. Customer requirements will be met if the organization listens to customers
and designs and manufactures its products accordingly. Prices can be more competitive because waste is minimized as
improved processes become more efficient, benefiting both the organization and its customers. Customers have increased
confidence in the products and services of ISO 9000-registered organizations because they know that appropriate quality
management processes are employed and that an independent registrar ensures that this continues to occur.

14.8 THE ORIGIN OF ISO 9000

ISO 9000 and total quality management originated independently of each other, for different reasons, in different parts of the
world, and at different times. From earlier chapters, you are already familiar with the post–World War II origins in Japan of
the total quality movement. ISO 9000 series of standards was originally developed in response to the need to harmonize
dozens of national and international quality standards that then existed throughout the world. To that end, the ISO, a
worldwide federation of national standards organizations from more than 158 nations, formed Technical Committee 176 to
develop ISO 9000.

ISO 9000 was developed by this international team that includes the American National Standards Institute (ANSI), the U.S.
member of ISO. The ANSI was represented by the American Society for Quality (ASQ), its affiliate responsible for quality
management and related standards. The first version of ISO 9000 was released in 1987. By that time, the total quality
management movement was more than 35 years old. As a result of this standard, suppliers of products and services are
able to develop and employ a QMS that is recognized by all their customers regardless of where on the planet those
customers might be.

14.9 COMPARATIVE SCOPE OF ISO 9000 AND TOTAL QUALITY MANAGEMENT

There are two principal quality initiatives at work in the world today: ISO 9000 and Total Quality Management. Consequently,
it is helpful to explain the relationship between the two. The following statements outline the relationship. Each statement is
explained in the sections that follow in this chapter.

■■ ISO 9000 and TQM are not interchangeable.

■■ ISO 9000 is compatible with, and can be viewed as a subset of, TQM.
■■ ISO 9000 is frequently implemented in a non-TQM environment.
■■ ISO 9000 can improve operations in a traditional environment.
■■ ISO 9000 may be redundant in a mature TQM environment.
■■ ISO 9000 and TQM are not in competition.

ISO 9000 and TQM Are Related but Not Interchangeable

Although ISO 9000 made a great leap toward TQM with the 2000 and 2008 releases, they are not yet the same, and
5

probably never will be. By definition, ISO 9000 is concerned only with quality management systems for the design,
Page

development, purchasing, production, installation, and servicing of products and services.

 CBM 131 Operations Management and Total Quality Management

On the other hand, total quality management, by definition, encompasses every aspect of the business or organization,
not just the systems used to design, produce, and deploy its products and services. This includes all support systems such
as human resources, finance, and marketing. Total quality management involves every function and level of the organization,
from top to bottom.

The primary difference between ISO 9000 and TQM is in the degree to which the total organization is involved. Whereas
TQM requires the involvement of all functions and levels of the organization, ISO 9000 does not require the QMS to include
functions and levels that play only indirect roles in the management and execution of the product or service realization
processes. Functions that typically are not involved under the QMS include human resources, finance (accounting), sales,
and marketing.

ISO 9000 Is Compatible with, and Can Be Viewed as a Subset of, TQM

Clearly, TQM and ISO 9000 are not quite the same thing. However, there is nothing inherent in ISO 9000 that would prevent
it from becoming part of a larger total quality management environment. There are many examples today of companies that
have successfully included ISO 9000 as part of a larger total quality effort. Organizations that are already at some level of
TQM maturity typically have found it easy to implement ISO 9000. This is because a TQM environment, with its infrastructure
of top-management commitment, documented processes and procedures, continuous improvement, obsession with quality,
and so on, easily supports the requirements of ISO 9000.

ISO 9000 Is Frequently Implemented in a Non-TQM Environment

Although total quality is compatible with and may well facilitate an ISO 9000 implementation, it is by no means a prerequisite
for ISO 9000. In fact, it is safe to say that the majority of ISO 9001–registered organizations have not fully adopted total
quality—at least, not yet.

ISO 9000 Can Improve Operations in a Traditional Environment

By “traditional environment,” we mean an organizational environment that has persisted in companies for decades, until the
total quality management movement began to change things. A traditional organizational environment is one that still
operates according to the “old way of doing things” rather than according to the principles of TQM.

When ISO 9000 is implemented by a traditional organization, the company should be the better for it. We will not go so far as
to say it will be the better for it because much depends on the organization’s reasons for adopting ISO 9000 and the degree
of executive-level commitment to it. Put another way, if ISO 9000 is approached inappropriately and for the wrong reasons, it
can become nothing more than a marketing ploy, and the organization’s functional departments might develop even more
problems than they had before ISO 9000.

ISO 9000 May Be Redundant in a Mature TQM Environment

Just as ISO 9000 should help traditional organizations, it should also benefit TQM organizations. However, in an organization
that has achieved a high level of maturity in its total quality journey—say, in the 400–600 range on the Baldrige scale of
1,000 points—all ISO 9000 criteria may already be in place. In such a case, the only compelling reason for registration under
ISO 9001 would be for marketing purposes. What would a company such as Toyota gain from ISO 9000 registration?
Probably nothing. It already does everything required by ISO 9000. Its products and processes are recognized as world
class. Consequently, it wouldn’t gain even a marketing advantage. However, there are many fine TQM organizations that are
not as well known as Toyota. Such organizations, even though they may already meet or exceed the requirements of ISO
9000, may find it necessary to register in order to let potential customers know that their products or services satisfy the
international standard.
6
Page
 CBM 131 Operations Management and Total Quality Management

ISO 9000 and TQM Are Not in Competition

This is not a case of one or the other. Organizations can adopt TQM or ISO 9000, or both. While there may be those who
advocate one to the exclusion of the other, in the larger scheme of things the two concepts fit well with each other. Both have
worthwhile and similar aims. Our view is that not only are TQM and ISO 9000 compatible but they also actually support each
other and are complementary. There are good reasons for using both in a single management system.

14.10 MANAGEMENT MOTIVATION FOR REGISTRATION TO ISO 9001

Management motivation for adopting either ISO 9000 or TQM can vary widely. There are both appropriate and inappropriate
motives. For example, if a company seeks ISO 9001 registration merely to obtain a marketing advantage, its motive is
inappropriate. As a result, the organization will likely give little more than lip service to adopting the standard. Appropriate
motives for adopting ISO 9000 include the following:

■■ To improve operations by implementing a QMS that satisfies the ISO 9000 requirements for management responsibility;
resource management; product realization; and measurement, analysis, and continual improvement
■■ To create or improve a QMS that will be recognized by customers worldwide
■■ To improve product or service quality or the consistency of quality
■■ To improve customer satisfaction
■■ To improve competitive posture
■■ To conform to the requirements of one or more major customers (although adoption would be better motivated by
internal considerations, such as the preceding five)

What we are saying here is that, ideally, management will adopt ISO 9000 as a way to make real improvements in the
company’s operations, serve its customers in a more responsible way, and, as a result, be more successful. This
approach is more likely to ensure commitment and participation by top management. If ISO 9000 is to have a real and
permanent effect, it must be approached with a positive attitude and the unwavering commitment of top management.

14.11 ISO 9000 AND TOTAL QUALITY MANAGEMENT WORKING TOGETHER

We have discussed the fact that ISO 9000 and TQM are different in scope and were developed from different perspectives
but now have similar requirements and objectives. Today, more than ever, the two concepts are compatible. With the
exception of certification and audits, TQM requires everything required by ISO 9000 registration. However, even a mature
TQM organization, one that does everything it would do under ISO 9000 and more, may not have the worldwide recognition
afforded by ISO 9000 registration. There is no corresponding international certification for TQM. For this reason, even the
mature TQM organization may find it necessary to seek ISO 9000 registration as a way to satisfy the demands of its
customers. On the other hand, a traditional organization that is registered under ISO 9001 may find that it needs the larger
TQM implementation to become or stay competitive. ISO 9001 registration can be a good first step into TQM.

In fact, people who understand both ISO 9000 and total quality have concluded that the two are compatible and that ISO is
properly seen as a subset of total quality.

Movement from ISO 9000 to TQM and Vice Versa

An organization that has its processes documented and under control, such as a company involved in total quality
management, should find it relatively easy to prepare for ISO 9000. Correspondingly, a traditional organization that has
successfully registered under ISO 9001 will have a head start, should it decide to implement total quality. The major issues
with ISO 9000 are securing top-management commitment, focusing on customer requirements and satisfaction, and
documenting processes and procedures. Total quality management requires the same.
7
Page
 CBM 131 Operations Management and Total Quality Management

ISO 9000 as an Entry into Total Quality Management

How to get started is always an issue for organizations just beginning their total quality journey. Organizations beginning
the process may find that a good strategy is registration to the ISO 9001 standard. ISO 9000 preparation projects can be
pursued as the entry projects for implementing total quality management.

We have already discussed the fact that ISO 9000 and total quality are compatible, making many of the same demands
on the organization, and also that ISO 9000 is, for all practical purposes, a subset of total quality. For an organization
that is attempting to adopt total quality and that would also benefit from ISO 9000.

In summary, the organization that is already involved in ISO 9000 should see itself as having a head start on the larger TQM
implementation. One that has started neither, although seeing TQM and ISO 9000 as beneficial, might approach
ISO 9001 as a logical part of the initial total quality journey.

14.12 THE FUTURE OF ISO 9000

Credibility of the Standard

Consider for a moment the importance of credibility as related to ISO 9000 registrations. ISO 9000 is viable as a standard
only as long as its registrations are honestly and competently issued. If that cannot be assured, then ISO 9000 will die.
Many, including the authors, believe that the credibility of ISO certification has become diluted because there has been
insufficient oversight of the registrars. Registrar conformity will be verified by the accrediting bodies, both by reviewing
the registrar’s organization, personnel, and procedures and by observing actual audits performed by the registrar. With
this step, ISO has implemented a critical safeguard for the credibility of ISO 9000.

Updating ISO 9000

ISO 9000 has been revised three times since its original release. The 2000 version incorporated major changes in the
standard as it was being developed and improved through the incorporation of features from total quality management.
The 2008 version has few significant changes.

14.13 ISO 9000: VERSIONS/UPDATES

Since the development of the first ISO standard in 1987, the standard has been updated periodically to reflect lessons
learned and changes in the international business arena. The various updates to ISO 9000 are summarized as follows:

■■ ISO 9000:1987. This initial version of the ISO 9000 standard contained three models for quality management systems. It
was structured like the United Kingdom’s BS 5750 Standard. The three models for quality management systems were: (1)
ISO 9001:1987—Quality Assurance in Design, Development, Production, and Installation Services; (2) ISO 9002:1987—
Quality Assurance in Production, Installation, and Servicing (did not cover the development of new products); and (3) Quality
Assurance in Final Inspection and Test. This version required mountains of paperwork as evidence of compliance with
documented procedures. Many organizations thought the “cure” was worse than the “disease” when applying this version of
the standard.
■■ ISO 9000:1994. This version continued to require comprehensive evidence of compliance with properly documented
procedures, but it did begin to move toward process improvement by emphasizing preventive actions rather than just
checking the final product. However, it was a burdensomely bureaucratic standard in which the “cure” was still worse than
the “disease.”
■■ ISO 9001:2000. This version combined ISO 9001, 9002, and 9003 into one document that is ISO 9001. The
distinguishing feature of this version is that it was brought more closely in line with the basic tenets of quality management.
8
Page
 CBM 131 Operations Management and Total Quality Management

■■ ISO 9001:2008. This version is not substantively different from ISO 9001:2000, but there are several additional
requirements that are important.
■■ ISO 9001:2015. As of this writing, the new ISO 9001:2015 standard will be a major revision that will bring quality more in
line with business and the strategic aspects of an organization rather than treating it like a separate entity. For example, the
Quality Policy and Quality Objectives in the QMS will have to be compatible with the strategic direction of the company. A
major revision will be in the area of risk. ISO 9001:2015 introduces the concept of risk-based thinking and requires
organizations to consider and plan for four types of risk: (1) organizational risk, (2) strategic risk, (3) compliance risk, and (4)
operational risk.

ISO 9001: The Contents

When the original three ISO standards—9001, 9002, 9003—were combined to create ISO 9001:2000, the contents of the
new document were also standardized. The contents of ISO 9001 are now as follows:

■■ Foreword
■■ Introduction
■■ Requirements
Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and Definitions
Section 4: Quality Management System
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Product Realization
Section 8: Measurement, Analysis, and Improvement

Organizations seeking ISO 9000 registration are required to address all eight sections of the standard, but only
sections 4 through 8 require implementation within the QMS.

---the END---

No more activity.

Study lessons 11, 12, 13 and 14 for the final exams.

God bless.
9
Page