iso 9001-2008 expanded and explained jack west sample

ISO 9001:2008 Explained and

Expanded

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Also available from ASQ Quality Press:

ISO 9001:2008 Explained, Third EditionCharles A. Cianfrani, Joseph J. Tsiakals, and John E. (Jack) West

How to Audit the Process Based QMS, Second EditionDennis R. Arter, Charles A. Cianfrani, and John E. (Jack) West

Cracking the Case of ISO 9001:2008 for ManufacturingJohn E. (Jack) West and Charles A. Cianfrani

Cracking the Case of ISO 9001:2008 for ServiceJohn E. (Jack) West and Charles A. Cianfrani

ISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third EditionJ. P. Russell and Dennis R. Arter

ISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-By-Step Guidelines for Successful Internal Audits, Second EditionAnn W. Phillips

The ASQ Auditing Handbook, Fourth EditionJ. P. Russell, editing director

Quality Audits for Improved Performance, Third EditionDennis R. Arter

The Quality Toolbox, Second EditionNancy R. Tague

Mapping Work Processes, Second EditionBjørn Andersen, Tom Fagerhaug, Bjørnar Henriksen, and Lars E. Onsøyen

Lean Kaizen: A Simplified Approach to Process ImprovementsGeorge Alukal and Anthony Manos

Root Cause Analysis: Simplified Tools and Techniques, Second EditionBjørn Andersen and Tom Fagerhaug

The Certified Manager of Quality/Organizational Excellence Handbook, Fourth EditionRussell T. Westcott, editor

To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our website at http://www.asq.org/quality-press.


ISO 9001:2008 Explained and

ExpandedMaking Your

Quality Management System Sustainable

Charles A. CianfraniJohn E. (Jack) West

ASQ Quality PressMilwaukee, Wisconsin


American Society for Quality, Quality Press, Milwaukee 53203© 2014 by ASQAll rights reserved. Printed in the United States of America19 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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ASQ Mission: The American Society for Quality advances individual, organiza-tional, and community excellence worldwide through learning, quality improve-ment, and knowledge exchange.

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Printed on acid-free paper


v

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 . . . . 5A Few Processes That Deserve

Special Attention . . . . . . . . . . . . . . . . 12Summary . . . . . . . . . . . . . . . . . . . . . . . . . 16Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Chapter 2 Building Your Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Basics of Process Management . . . . . . . . 20Summary . . . . . . . . . . . . . . . . . . . . . . . . . 29Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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? . . . . . . . . . 41Summary . . . . . . . . . . . . . . . . . . . . . . . . . 44Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . 49Addressing Correction, Corrective

Action, and Preventive Action . . . . . . 56Managing Incremental and Breakthrough

Improvement . . . . . . . . . . . . . . . . . . . 62The Relationships among Policy,

Objectives, and Alignment . . . . . . . . . 63Simplicity and Systems Thinking . . . . . . 69Manage by Facts: The Importance of

Obtaining and Analyzing Data . . . . . . 74“Output Matters” as a Core Value . . . . . . 77Summary . . . . . . . . . . . . . . . . . . . . . . . . . 78Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . 104Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Chapter 6 Future Quality Management System Challenges . . . . . . . . . . . . . . . . . . . . . . . . 107

The Communication Challenge . . . . . . . . 108Planning for the Future . . . . . . . . . . . . . . 112Summary . . . . . . . . . . . . . . . . . . . . . . . . . 120

Chapter 7 Revitalizing Your Quality Management System . . . . . . . . . . . . . . . 123

The Stable State . . . . . . . . . . . . . . . . . . . . 123How the System Should Work . . . . . . . . . 124People and the Quality System . . . . . . . . 127A Role of Management Review . . . . . . . . 129Set the Bar . . . . . . . . . . . . . . . . . . . . . . . . 131Each Employee’s Role . . . . . . . . . . . . . . . 132Shared Vision . . . . . . . . . . . . . . . . . . . . . . 134Summary . . . . . . . . . . . . . . . . . . . . . . . . . 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


ix

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 . . . . . . . . . . . . . . . . . . . . . 2Table 1.1 Characteristics of incremental and

breakthrough improvements . . . . . . . . . . 14Figure 1.2 Incremental and breakthrough

improvement . . . . . . . . . . . . . . . . . . . . . . 15Figure 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 . . . . . . . 23Figure 2.4 A family of well-managed processes . . . . 24Figure 2.5 Process relationship of ISO 9001:2008

to ISO 9004:2009 . . . . . . . . . . . . . . . . . . . 27Figure 3.1 The audit process . . . . . . . . . . . . . . . . . . . 35Figure 3.2 Conducting the audit . . . . . . . . . . . . . . . . 35Figure 3.3 Audit inputs and outputs, resources

required, and management role . . . . . . . . 39Figure 4.1 Validation that product designs meet

customer requirements—summary of requirements . . . . . . . . . . . . . . . . . . . . . . . 51

Figure 4.2 Design controls illustrated . . . . . . . . . . . . 52


x List of Figures and Tables

Figure 4.3 Appropriate attitudes and actions . . . . . . . 61Figure 4.4 The role of management review in

improvement . . . . . . . . . . . . . . . . . . . . . . 64Figure 4.5 Measure process parameters that drive

process output results . . . . . . . . . . . . . . . . 65Table 5.1 Performance maturity levels . . . . . . . . . . 86Table 5.2 Example of reporting self-assessment

results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Table 6.1 Conference Board CEO Challenge 2012:

Synopsis of survey results . . . . . . . . . . . . 113Figure 6.1 Forces affecting the future of quality . . . . 114Figure 7.1 Considerations for sustaining growth . . . 126


xi

Preface

Survival 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 not- for-profit, regulated and not regulated, and in many different industries throughout the world. Why


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 CianfraniJack WestMay 2013


xv

This 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 Improvement3 (see Chapters 4–7)

Introduction


xvi Introduction

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).

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

What we need to doto be successful (4)

Need to continuallyrevitalize the QMS (7)

Why? (1)

The futureof quality

(5)

ISO 9001 ISO 9001++ (6)

What we need to doto pass an audit (3)

QMS elementsto consider (2)


1

1

Why Bother with Conformity?

Chapter One

Why 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.


2 Chapter One

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

Figure 1.1 Output matters.

Leadership, planning, support,and resource management

Performance evaluationand feedback

Context of theorganization

Operational planning and control

Product (and/or service) realization

Cu

sto

mer

req

uir

emen

ts Cu

stom

er satisfaction

QMS improvement


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 well- 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 Explained2 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 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

table 1.1 Characteristics of incremental and breakthrough improvements.

incremental improvement

Breakthrough improvement

people involved

People working in the process

Managers, engineers, consultants

Size of changes

Small, incremental changes

Big changes

types of changes

Practices, procedures, equipment modifications, elimination/simplification of activities, process foolproofing

Technology, new equipment, major process upgrades, process reengineering

results Small improvements Large “jumps” in performance

Cost of projects

Low, generally included in operating budget

High, may involve capital investment



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, spin- 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

Figure 1.2 Incremental and breakthrough improvement.

Operating undercontrolled conditions

UPis

good

5 years

Benchmark:Best-in-classperformance

Incremental

Breakthroughin 18 months

Breakthrough target:Be 5% better than

benchmark in 18 months

18months


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

1. J. West and C. A. Cianfrani, Unlocking the Power of Your QMS: Keys to Business Performance Improvement (Milwaukee, WI: ASQ Quality Press, 2004), chapter 1.

2. C. A. Cianfrani, J. J. Tsiakals, and J. West, ISO 9001:2008 Explained, 3rd ed. (Milwaukee, WI: ASQ Quality Press, 2009).


151

Index

Note: Page numbers followed by f refer to figures; those followed by t refer to tables.

Aactions

alignment and, 66–67attitudes and, 61fconformance, for ISO 9001:2008,

17, 22, 24–25corrective, 56–59, 61f, 104preventive ISO 9001:2008, 59–61,

61fagility, focus on, 7, 100alignment, understanding, and

practice of, 63–69actions taken, 66–67management role and, 63–64,

64fmeasurement and, 64–66, 65fmission statement and, 67, 69self-assessment tactical examples

of, 92–93vision statement and, 67–69

American Society for Quality (ASQ), 26

Future of Quality Study, 112, 113–114, 114f

analysis process (clause 8), 25, 27fattitudes, actions and, 61fauditing, 31–45

categories of, 31clause 8.2.2, 31, 33, 38conducting of, 35f

cost of nonconformity and, 42, 43–44

definition of, 33described, 33internal quality, 33–34, 39fminimum requirements for, 38–39,

39fprinciples of, conductors, 34process of, 35fquality improvement and, 32registration/regulatory compliance,

34scope and depth of, expanding,

41–44sector-specific standards and,

42–43vs. self-assessment and

management review, 36–38stages of, process, 34–35, 35fsupplier, 34tips for passing, 40–41uses for, 32–33

auditors, principles of, 34

BBaldrige Performance Excellence

Program, 82breakthrough improvement, 13–15

characteristics of, 14tconcepts of, 15fmanaging, 62–63

H1446_Cianfrani_pi_160.indd 151 11/5/13 12:34 PM

152 Index

Cchange management, 15–16

globalization and, 101–102strategic planning and, 98–104

changing conditions, quality management system and, 93, 124–127, 126f

clause 4, identification and management, 22, 24, 27f

clause 5, management responsibility, 24, 27f

clause 6, resource management, 24, 27fclause 7, product realization, 24, 27f,

50, 51f, 53–54clause 8, measurement, analysis, and

improvement, 25, 27f, 31, 33, 38clause 9, improvement, innovation,

and learning, 27fcommunication

acronyms and, 108–109Cost of Quality process and,

111–112gulf, bridging, 109–110negative reactions, overcoming,

110quality professional continued

development and, 111quality professionals and

executives, between, 108–112qualityspeak, avoiding, 110

competence requirements, ISO 9001:2008, 48–49

Conference Board CEO Challenge, 26, 112–113, 113t

challenges identified by, 115–120conformity, ISO 9001:2008, 1–4, 2f,

16–17middle managers reasons for,

2–3organization reasons for, 1, 2f, 4survival and, 4sustainability and, 3–4top managers reasons for, 3workers reasons for, 2

consumer awareness, 29continual improvement, 8

causes of problems and, 62

core value, 3, 31, 77–78correction, 58, 61f, 104corrective action, 56–59, 61f, 104cost of nonconformity, auditing and,

42, 43–44Cost of Quality process, 44, 98,

111–112cost optimization, quality

management system and, 118–119

Crosby, Philip, 102customer relationships, quality


customers, focus on, 6, 93–94customer satisfaction, 128

Ddata analysis, 74–77, 94–95Deming, W. Edwards, 102design of experiments (DOE), 97design review, product, 52–53, 52fdesign validation, product, 52f, 53design verification, product, 52f, 53development, product, 53, 94, 105documentation

data analysis and, 74–77, 94–95requirements for, 76–77

Duncan, Acheson, 102

Eeffectiveness, 12–13

addressing, 47–48efficiency, 12–13

addressing, 47–48employee’s role in quality

management system, 132–134European Foundation for Quality

Management (EFQM) Excellence Model, 25, 82

excellence models, processes derived from, 25–26

Ffacts, decision making and, 8failure modes and effects analysis

(FMEA), 16


Index 153

Feigenbaum, Armand, 102first-party audits, 31future, focus on, 7

Gglobal expansion, quality


globalization, 26, 28, 101–102

HA History of Managing for Quality

(Juran), 96–97How to Audit the Process-Based QMS

(Arter, Cianfrani, and West), 34, 35, 39

human capital, quality management system and, 116–117

human resource management, self-assessment tactical examples of, 95–96

Iidentification and management

(clause 4), 22, 24, 27fimprovement

alignment and, 66–67breakthrough, 13–15continual, 8incremental, 13–15management review role in, 64fprocess (clause 8), 25, 27f

incremental improvement, 13–15characteristics of, 14tconcepts of, 15fmanaging, 62–63

innovationcontinual, 8, 29, 96quality management system

(QMS) and, 115–116interrelated processes, managing

system of, 7ISO 9001:2008

alignment, understanding, and practice of, 63–69, 64f, 65f

auditing and, 32–33

certification audit, tips for passing, 40–41

competence requirements of, 48–49

compliance with, 12–16conformance actions for, 17, 22,

24–25conformity with, reasons for (see

conformity, ISO 9001:2008)corrective and preventive action,

56–61data analysis and, 74–77effectiveness and efficiency,

addressing, 47–48to establish QMS foundation, 5–12incremental/breakthrough

improvement, managing, 62–63

intent of, 16levels of adherence to, xvminimum requirements for,

expanding beyond, 4–5processes for conformity to, 22,

24–25product and process validation,

49–56, 51f, 52fproduct conformance and, 77–78systems approach to management

and, 69–74ISO 9001:2008 Explained (Cianfrani,

Tsiakals, and West), xv, 12, 39, 41

ISO 9004:2009for conformity, 22, 24–25processes from, 26–29, 27fquestions for planning/conducting

self-assessment to, 139–150ISO 9004:2009, Quality management

systems—Managing for the sustained success of an organization, xv

ISO-compliant process, implementing, 12–16

change management and, 15–16continual improvement and, 13–15process effectiveness/efficiency

and, 12–13

H1446_Cianfrani_pi_160.indd 153 11/5/13 12:34 PM

154 Index

JJuran, Joseph, 97, 102

Lleadership, providing, 7lean, 97learning, continual, 8

M“magical” solutions, 96–98Malcolm Baldrige National Quality

Award, 25management, systems approach to,

69–74benefits of, 71–72big-picture thinking techniques, 71complexity and, 72–73described, 69–70processes and, 70–71simplicity, steps to encourage,

73–74management responsibility (clause 5),

24, 27fmanagement review, 36

role of, in quality management system, 129–131

management systems, integrating, 28–29

managers, topISO 9001:2008 conformity and, 3mission/vision statements and,

10–11quality professional and, 9tasks of, 9

measurement process (clause 8), 25, 27fmission statements

alignment and, 67, 69revising, 10–11

Nnonconformity, cost of, 42, 43–44

Oobjectives, alignment of, 7organizational excellence models.

See quality award models, self-assessment

Ppartner development, 8people

organization and, 8process use by, 20, 21fquality management system and,

127–129performance, improving, 128–129plan-do-check-act (PDCA), 61prevention, 59, 98, 111, 119preventive action, 59–61, 61f, 104

developing, during planning process, 60–61

ISO 9001:2008 references to, 59problems, causes of, 62processes

change management, 15–16continual improvement, 13–15,

14t, 15fcontrol mechanisms of, 21, 21fdefined, 20, 20fderived from excellence models,

25–26effectiveness, 12–13, 47–48efficiency, 12–13, 47–48from ISO 9004:2009, 26–29, 27fresources people use within, 20,

21fsupport of, 21fwell-managed example of, 24f

process management. See also processes

basics of, 20–21, 20f, 21fISO 9001:2008 needs of, 22,

24–25quality management system and,

19–30system management and, 21–22,

23f, 24fproduct and process validation, ISO

9001:2008, 49–56, 51f, 52felements of, 54–55

product designreview, 52–53, 52fvalidation, 52f, 53verification, 52f, 53

product development, 53, 94, 105


Index 155

product realization (clause 7), 24, 27f, 50, 51f, 53–54, 94

purpose, providing, 7

QQMS. See quality management

system (QMS)quality

business relationship of, 99–100ISO 9000:2005 definition of, 128working definition of, 128

quality assurance personnelexecutive management language

and, 100strategic planning and, 99

quality auditing. See auditingquality audits, internal, 33–34quality award models, self-

assessment, 82–90conducting phase tasks of, 84, 90examples of, 82initiating, 83maturity levels and, 85, 86tplanning phase tasks of, 83reporting phase tasks of, 84–85,

87–89, 89tstep-by-step model of, 85–87

quality management principles (QMPs), 6–10, 103

quality management system (QMS). See also process management

auditing, 31–45building, 19–30creating sustainable, xv-xvi, xvif,

5–12current system, understanding, 5–6future of (see quality management

system [QMS], future of)mission/vision statements and,

10–11processes for, 11–12quality management principles

and, 6–10revitalization of (see quality

management system [QMS], revitalization of)

structure and deployment of, 5–12

quality management system (QMS), future of

actions to consider from report data for, 114–115

ASQ 2011 study on, 113–114, 114f

communication challenge, 108–112

Conference Board and, 112–113, 113t

cost optimization and, 118–119customer relationships and,

119–120global expansion and, 117–118human capital and, 116–117innovation and, 115–116overview, 107–108planning for, 112–120

quality management system (QMS), revitalization of

changing conditions and, 93, 124–127, 126f

employee’s role and, 132–134management review role and,

129–131people and, 127–129setting the bar and, 131–132shared vision and, 134–135stable state and, 123–124

quality professionalcapabilities of, 101communication challenges of,

108–112concepts of, 102

Rregistration/regulatory compliance

audits, 34resource management (clause 6), 24,

27fresults, focus on, 7right-first-time (RFT), 61

Ssecond-party audits, 31sector-specific standards, auditing

and, 42–43


156 Index

self-assessmentconducting models for (see quality

award models, self-assessment)described, 36, 81–82example, 85–87intent of, 36–37vs. internal auditing, 36–38, 81ISO 9004:2009, questions for

planning/conducting, 139–150literature on, 37maturity levels and, 85, 86toutput of, 81–82questions asked and investigated

in, 90–92reports, 87–88, 89tstrategic examples of, 98–104tactical examples of, 92–98

setting the bar, quality management system and, 131–132

shared vision, quality management system and, 134–135

Shingo, Shigeo, 58Six Sigma, 97social responsibility, 6–7, 28stable state, quality management

system and, 123–124stakeholder development, 8statistical process control (SPC), 97strategic self-assessment examples,

98–104supplier audits, 34supplier development, 8sustaining growth, considerations for,

126f

systems approach to management, 69–74

benefits of, 71–72big-picture thinking techniques, 71complexity and, 72–73described, 69–70processes and, 70–71simplicity, steps to encourage,

73–74

Ttactical self-assessment examples,

92–98third-party audits, 31total quality management (TQM), 97

UUnlocking the Power of Your QMS:

Keys to Business Performance Improvement (West and Cianfrani), xv, 8

Vvalue stream mapping, 102–103vision, providing, 7vision statements

alignment and, 67–69revising, 10–11

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CERTIFICATION MEMBERSHIP PUBLICATIONSTRAININg CONFERENCES


iso 9001-2008 expanded and explained jack west sample

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