ISO 9001:2008 Explained and Expanded

Also available from ASQ Quality Press: ISO 9001:2008 Explained, Third Edition Charles A. Cianfrani, Joseph J. Tsiakals, and John E. (Jack) West How to Audit the Process Based QMS, Second Edition Dennis R. Arter, Charles A. Cianfrani, and John E. (Jack) West Cracking the Case of ISO 9001:2008 for Manufacturing John E. (Jack) West and Charles A. Cianfrani Cracking the Case of ISO 9001:2008 for Service John E. (Jack) West and Charles A. Cianfrani ISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third Edition J. P. Russell and Dennis R. Arter ISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-ByStep Guidelines for Successful Internal Audits, Second Edition Ann W. Phillips The ASQ Auditing Handbook, Fourth Edition J. P. Russell, editing director Quality Audits for Improved Performance, Third Edition Dennis R. Arter The Quality Toolbox, Second Edition Nancy R. Tague Mapping Work Processes, Second Edition Bjrn Andersen, Tom Fagerhaug, Bjrnar Henriksen, and Lars E. Onsyen Lean Kaizen: A Simplified Approach to Process Improvements George Alukal and Anthony Manos Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bjrn Andersen and Tom Fagerhaug The Certified Manager of Quality/Organizational Excellence Handbook, Fourth Edition Russell 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 Expanded

Making Your Quality Management System Sustainable

Charles A. Cianfrani John E. (Jack) West

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203 2014 by ASQ All rights reserved. Printed in the United States of America 191817161514 54321 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 controlStandards. I. West, Jack, 1944 II. Title TS156.6.C45155 2014 658.4013dc23 2013038425 No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher. Acquisitions Editor: Matt Meinholz Managing Editor: Paul Daniel OMara Production Administrator: Randall Benson ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange. Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005. To place orders or to request a free copy of the ASQ Quality Press Publications Catalog, visit our website at http://www.asq.org/quality-press. Printed on acid-free paper

Contents
List of Figures and Tables. . . . . . . . . . . . . . . . . . . . . . . . . Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 1 ix xi xv

Why Bother with Conformity?. . . . . . . . 1 Why Should an Organization Want to Expand Beyond the Minimum Requirements of ISO 9001:2008?. . . . 4 Where and How to Start the Journey. . . . . 5 A Few Processes That Deserve Special Attention. . . . . . . . . . . . . . . . . 12 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Building Your Quality Management System. . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Basics of Process Management. . . . . . . . . 20 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Why Is Quality Auditing Important?. . . 31 The BasicsA Summary . . . . . . . . . . . . . 33

Chapter 2

Chapter 3

vi Contents

The Distinction between Audit, Self-Assessment, and Management Review. . . . . . . . . . . . . . . . . . . . . . . . . 36 What Are the Minimum Requirements forAuditing?. . . . . . . . . . . . . . . . . . . . 38 Tips on How to Pass an ISO 9001:2008 Certification Audit. . . . . . . . . . . . . . . . 40 Going Beyond the Minimum?. . . . . . . . . . 41 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Chapter 4 What Is Needed to BeSuccessful . . . . . . 47 Addressing Effectiveness (Capability and Capacity) and Efficiency (WasteElimination). . . . . . . . . . . . . . . 47 Addressing Competence: Embedding Learningas a Formal Process . . . . . . . 48 Product and Process Validation. . . . . . . . . 49 Addressing Correction, Corrective Action,andPreventive Action. . . . . . . 56 Managing Incremental and Breakthrough Improvement . . . . . . . . . . . . . . . . . . . . 62 The Relationships among Policy, Objectives,and Alignment. . . . . . . . . . 63 Simplicity and Systems Thinking . . . . . . . 69 Manage by Facts: The Importance of Obtainingand Analyzing Data. . . . . . . 74 Output Matters as a Core Value. . . . . . . 77 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Go Beyond WhereItMatters . . . . . . . . . 81 How to Conduct a SelfAssessment: A Primer. . . . . . . . . . . . . . . . . . . . . . . . 82

Chapter 5

 Contents

vii

Where Can Self- Assessment Results Indicate a Need to Go Beyond MinimumRequirements?. . . . . . . . . . . 90 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Chapter 6 Future Quality Management System Challenges. . . . . . . . . . . . . . . . . . . . . . . . . 107 The Communication Challenge. . . . . . . . . 108 Planning for the Future . . . . . . . . . . . . . . . 112 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 120 Revitalizing Your Quality ManagementSystem . . . . . . . . . . . . . . . . 123 The Stable State. . . . . . . . . . . . . . . . . . . . . 123 How the System Should Work. . . . . . . . . . 124 People and the Quality System . . . . . . . . . 127 A Role of Management Review. . . . . . . . . 129 Set the Bar. . . . . . . . . . . . . . . . . . . . . . . . . 131 Each Employees Role. . . . . . . . . . . . . . . . 132 Shared Vision. . . . . . . . . . . . . . . . . . . . . . . 134 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Chapter 7

Epilogue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 Questions an Assessor Can Consider Appendix  inPlanning and Conducting a Self-Assessment to the Contents of ISO9004:2009 . . . . . . . . . . . . . . . . . . . 139 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

List of Figures and Tables

Figure I.1 Figure 1.1 Table 1.1 Figure 1.2 Figure 2.1 Model for the content of ISO 9001:2008 Explained and Expanded. . . . . . . . . . . . . . xvi Output matters. . . . . . . . . . . . . . . . . . . . . . 2 Characteristics of incremental and breakthroughimprovements . . . . . . . . . . . 14 Incremental and breakthrough improvement . . . . . . . . . . . . . . . . . . . . . . . 15 Process: A set of interrelated or interacting activities that transform inputs into outputs. . . . . . . . . . . . . . . . . . . . . . . . 20 Processes are supported by resources and controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 An organizations process model. . . . . . . . 23 A family of well-managed processes. . . . . 24 Process relationship of ISO 9001:2008 to ISO 9004:2009. . . . . . . . . . . . . . . . . . . . 27 The audit process. . . . . . . . . . . . . . . . . . . . 35 Conducting the audit . . . . . . . . . . . . . . . . . 35 Audit inputs and outputs, resources required, and management role. . . . . . . . . 39 Validation that product designs meet customer requirementssummary of requirements. . . . . . . . . . . . . . . . . . . . . . . . 51 Design controls illustrated. . . . . . . . . . . . . 52
ix

Figure 2.2 Figure 2.3 Figure 2.4 Figure 2.5 Figure 3.1 Figure 3.2 Figure 3.3 Figure 4.1

Figure 4.2

List of Figures and Tables

Figure 4.3 Figure 4.4 Figure 4.5 Table 5.1 Table 5.2 Table 6.1 Figure 6.1 Figure 7.1

Appropriate attitudes and actions. . . . . . . . 61 The role of management review in improvement . . . . . . . . . . . . . . . . . . . . . . . 64 Measure process parameters that drive process output results. . . . . . . . . . . . . . . . . 65 Performance maturity levels . . . . . . . . . . . 86 Example of reporting self-assessment results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 Conference Board CEO Challenge 2012: Synopsis of survey results. . . . . . . . . . . . . 113 Forces affecting the future of quality. . . . . 114 Considerations for sustaining growth . . . . 126

Preface
urvival and sustainability are the key topics of this book. It is intended to encourage quality professionals to examine the structure and deployment of the quality management system (QMS) of an organizationto 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 discusses 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 chapter of activities to encourage the ongoing revitalization of the organizations QMS. Since its initial release in 1987, the ISO 9001 standard has been embraced by a wide range of organizationslarge and ot- for-profit, regulated and not regulated, small, for profit and n and in many different industries throughout the world. Why
xi

xii Preface

such widespread recognition and use of this standard? Users see it as a reasonable foundation for an effective QMS because it can promote internal control of process performance and improve operating effectiveness while enhancing customer satisfaction. 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 25plus 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 8.5Improvement. Quality management should be a continual migration 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 quality management both a tactical and strategic tool in achieving sustainability. Charlie Cianfrani Jack West May 2013

Introduction

his book is intended to provide users of ISO 9001:2008 Explained1 with guidance that can help an organization build a robust, sustainable QMS that focuses on achieving 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 implement their QMS (see Chapters 14) Users who do not need certification but want a more robust and efficient QMS can use this book without reference to ISO 9001:2008 Explained (see Chapters 36) Users already certified to or compliant with ISO 9001:2008 can gain greater QMS efficiency and organizational sustainability by using this book along with ISO 9004:2009, Quality management systemsManaging for the sustained success of an organization2 and Unlocking the Power of Your QMS: Keys to Business Performance Improvement 3 (see Chapters 47)

xv

xvi Introduction

Need to continually revitalize the QMS (7)

Why? (1)

The future of quality (5)

ISO 9001

ISO 9001++ (6)

QMS elements to consider (2)

What we need to do to pass an audit (3)

What we need to do to be successful (4)

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

One of the pioneers of quality management and statistical thinking observed many years ago that all models are wrong but some are very useful. Keep the model represented in FigureI.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 sustainability 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 systemsManaging for the sustained success of an organization (ISO/TC 176/SC 2, 2009). 3. J. West and C.A. Cianfrani, Unlocking the Power of Your QMS: Keys to Business Performance Improvement (Milwaukee, WI: ASQ Quality Press, 2004).

1
Why Bother with Conformity?

hy should an organization want to ensure effective conformity with ISO 9001? Over the past 25 years the answer to this question has become clear:

ISO 9001 has been embraced as an international model for quality management system (QMS) requirements, with over 1 million certified user organizations in over 100 countries! ISO 9001 has morphed from a set of requirements that focused on procedures and documents to one that focuses on system output through process management. It is the output of the system that matters. An ISO 9001conforming system has the potential of yielding output to delight customers. Customers do care whether an organization can demonstrate conformity with ISO 9001 requirements, but they care more about the output! Figure 1.1 illustrates this concept. Conformity with ISO 9001 requirements has demonstrated 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 minimum effort to pass an audit.
1

Chapter One

Context of the organization QMS improvement

Customer requirements

Leadership, planning, support, and resource management

Customer satisfaction

Performance evaluation and feedback

Operational planning and control Product (and/or service) realization

Figure 1.1 Output matters.

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

Why Bother with Conformity?

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 variability and making it easier to solve problems Fostered continual improvement as a core value and provided 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 meeting objectives. Top managers find that ISO 9001 has: Improved their organizations 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 objectives Improved b ottom- line performance by enhancing revenue 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 organizationor 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

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 foundation of uncompromising integrity, adventures into the world of performance excellence or attempts to implement and sustain improvement programs are futile exercises. ISO 9001 conformity can provide an organization with a foundation of uncompromising integritya 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 consider expanding processes and performance beyond minimum requirements. Examples include: Escalating customer expectations Continual pressure to lower costs and improve efficiency

Why Bother with Conformity?

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 minimum just to get by is likely to lead to the decline and potential 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 statements of the organization Develop, document, deploy, and improve processes consistent 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 organizations current system. Knowing the state of the current QMS is the starting point for an improvement journey.

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 improvements 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 improvement of products and processes are ingrained behaviors at all levels. Process performance is measured and tracked. The organization 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 sustainable QMS is to start with an understanding of the quality management principles (QMPs) that are the foundation of high- performing QMSs. An organization could invest considerable 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 revenues that enable an organization to exist. Focusing on meeting customers needs and expectations is therefore essential to organizational survival. 2. Focus on other interested parties (social responsibility). Owners, employees, other interested parties, and

Why Bother with Conformity?

society at large may all have a stake in the organizations performance. Focusing on the needs of these other stakeholders is necessary to sustain the organization 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 changing external conditions. This goes beyond achieving 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 objectives, and its vision for the future. Leaders should build an environment where all members can contribute to meeting the organizations objectives. 7. Establish and align objectives. Alignment of objectives in all areas of the organization enhances the ability 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.

Chapter One

9. Manage with facts supported by credible data. Decisions should be made using facts and data tempered with experience and intuition. 10. Engage in continual improvement, innovation, and learning. Organizations achieve excellence by learning, 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 provides 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 organizations QMS is not a trivial exercise, and mid- level or frontline it is not one that can be completed by 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.

Why Bother with Conformity?

So, where do top managers spend their time? In our experience 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 organizations doors open. Whether the money comes from banks, venture capitalists, or other sources, nobody will invest in your organization unless it has a w ell- validated product, a good potential revenue and cash stream, and good leaders in key jobs. Second, top managers work hard to find and retain customers. 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 managers 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 quality professional can: Implement financial measures of rework, scrap, customer returns, and all other costs related to internal nonconformity 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 excellence. 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, documented, and understood may be tedious, but this is a fundamental prerequisite to be fulfilled prior to attempting to devise or improve a QMS that is in full alignment with the organizations 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 business purpose and direction is often clouded or lost. Top managers may still know it, but they may not talk about it very often. Maintaining a constant, clear understanding of the organizations 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

Why Bother with Conformity?

11

leaders may need to consider the impact of these changes on the organizations mission and vision. This is the How associated 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 organizationis 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 organization. A very simplified synopsis of how to do this is as follows: Identify the processes needed throughout the organization Determine the sequence and interaction of these processes Determine the criteria and methods needed to ensure effective operation and control of all processes Build in process features that are certain to prevent future problems Monitor, measure, and analyze processes Embed corrective action and improvement processes

12

Chapter One

Our book ISO 9001:2008 Explained 2 provides extensive guidance 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 improvementboth incremental and breakthrough 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 efficiency 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

Why Bother with Conformity?

13

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 processes, 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 BothIncrementaland 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 improving the efficiency of compliant processes can enhance both organizational performance and customer satisfaction, thereby contributing to organizational sustainability. Remember, an organization that is not getting better is getting worse!
An organization that is not getting better is getting worse!

Improvement can occur in many ways. We will address two: incremental improvement and breakthrough improvement.

14

Chapter One

Table 1.1 C  haracteristics of incremental and breakthrough improvements. Incremental improvement People involved Size of changes Types of changes People working in the process Small, incremental changes Practices, procedures, equipment modifications, elimination/simplification of activities, process foolproofing Small improvements Low, generally included in operating budget Breakthrough improvement Managers, engineers, consultants Big changes Technology, new equipment, major process upgrades, process reengineering

Results Cost of projects

Large jumps in performance High, may involve capital investment

Table 1.1 summarizes the characteristics of each approach in terms of the people who are involved, the nature of the improvements, typical activities to effect the improvements, the results that can be expected, and the cost to implement the improvement 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. Lets consider an organization that provides job placement services. Suppose that over a five- year period the organization implemented several incremental improvement projects and made modest improvements in its job placements. After reaching 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

Why Bother with Conformity?

15

Benchmark: Best-in-class performance

Breakthrough target: Be 5% better than benchmark in 18 months

Incremental

Operating under controlled conditions

UP is good 5 years

Breakthrough in 18 months 18 months

Figure 1.2 Incremental and breakthrough improvement.

higher level than its best competitor. After a period of design review, capital equipment acquisition, and personnel training, a breakthrough level of performance was achieved, as shown in the performance graph. The project took time and financial 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

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 requirements 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 implementation 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 organization 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

Why Bother with Conformity?

17

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 satisfaction and operating efficiency. Quality management is not something 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 performance is not getting better is getting worse. It is also worthwhile to dispel the excuse that working to improve quality management 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 limited only by available resources and the ingenuity and creativity 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 organizations foundational QMPs Review of the measurement and reporting processes for relevance to top management (i.e., whether they are presented 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 organizations 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).

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

A
actions alignment and, 6667 attitudes and, 61f conformance, for ISO 9001:2008, 17, 22, 2425 corrective, 5659, 61f, 104 preventive ISO 9001:2008, 5961, 61f agility, focus on, 7, 100 alignment, understanding, and practice of, 6369 actions taken, 6667 management role and, 6364, 64f measurement and, 6466, 65f mission statement and, 67, 69 self-assessment tactical examples of, 9293 vision statement and, 6769 American Society for Quality (ASQ), 26 Future of Quality Study, 112, 113114, 114f analysis process (clause 8), 25, 27f attitudes, actions and, 61f auditing, 3145 categories of, 31 clause 8.2.2, 31, 33, 38 conducting of, 35f

cost of nonconformity and, 42, 4344 definition of, 33 described, 33 internal quality, 3334, 39f minimum requirements for, 3839, 39f principles of, conductors, 34 process of, 35f quality improvement and, 32 registration/regulatory compliance, 34 scope and depth of, expanding, 4144 sector-specific standards and, 4243 vs. self-assessment and management review, 3638 stages of, process, 3435, 35f supplier, 34 tips for passing, 4041 uses for, 3233 auditors, principles of, 34

B
Baldrige Performance Excellence Program, 82 breakthrough improvement, 1315 characteristics of, 14t concepts of, 15f managing, 6263 151

152 Index

C
change management, 1516 globalization and, 101102 strategic planning and, 98104 changing conditions, quality management system and, 93, 124127, 126f clause 4, identification and management, 22, 24, 27f clause 5, management responsibility, 24, 27f clause 6, resource management, 24, 27f clause 7, product realization, 24, 27f, 50, 51f, 5354 clause 8, measurement, analysis, and improvement, 25, 27f, 31, 33, 38 clause 9, improvement, innovation, and learning, 27f communication acronyms and, 108109 Cost of Quality process and, 111112 gulf, bridging, 109110 negative reactions, overcoming, 110 quality professional continued development and, 111 quality professionals and executives, between, 108112 qualityspeak, avoiding, 110 competence requirements, ISO 9001:2008, 4849 Conference Board CEO Challenge, 26, 112113, 113t challenges identified by, 115120 conformity, ISO 9001:2008, 14, 2f, 1617 middle managers reasons for, 23 organization reasons for, 1, 2f, 4 survival and, 4 sustainability and, 34 top managers reasons for, 3 workers reasons for, 2 consumer awareness, 29 continual improvement, 8 causes of problems and, 62

core value, 3, 31, 7778 correction, 58, 61f, 104 corrective action, 5659, 61f, 104 cost of nonconformity, auditing and, 42, 4344 Cost of Quality process, 44, 98, 111112 cost optimization, quality management system and, 118119 Crosby, Philip, 102 customer relationships, quality management system and, 119120 customers, focus on, 6, 9394 customer satisfaction, 128

D
data analysis, 7477, 9495 Deming, W. Edwards, 102 design of experiments (DOE), 97 design review, product, 5253, 52f design validation, product, 52f, 53 design verification, product, 52f, 53 development, product, 53, 94, 105 documentation data analysis and, 7477, 9495 requirements for, 7677 Duncan, Acheson, 102

E
effectiveness, 1213 addressing, 4748 efficiency, 1213 addressing, 4748 employees role in quality management system, 132134 European Foundation for Quality Management (EFQM) Excellence Model, 25, 82 excellence models, processes derived from, 2526

F
facts, decision making and, 8 failure modes and effects analysis (FMEA), 16

 Index 153

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

G
global expansion, quality management system and, 117118 globalization, 26, 28, 101102

H
A History of Managing for Quality (Juran), 9697 How to Audit the Process-Based QMS (Arter, Cianfrani, and West), 34, 35, 39 human capital, quality management system and, 116117 human resource management, selfassessment tactical examples of, 9596

I
identification and management (clause 4), 22, 24, 27f improvement alignment and, 6667 breakthrough, 1315 continual, 8 incremental, 1315 management review role in, 64f process (clause 8), 25, 27f incremental improvement, 1315 characteristics of, 14t concepts of, 15f managing, 6263 innovation continual, 8, 29, 96 quality management system (QMS) and, 115116 interrelated processes, managing system of, 7 ISO 9001:2008 alignment, understanding, and practice of, 6369, 64f, 65f auditing and, 3233

certification audit, tips for passing, 4041 competence requirements of, 4849 compliance with, 1216 conformance actions for, 17, 22, 2425 conformity with, reasons for (see conformity, ISO 9001:2008) corrective and preventive action, 5661 data analysis and, 7477 effectiveness and efficiency, addressing, 4748 to establish QMS foundation, 512 incremental/breakthrough improvement, managing, 6263 intent of, 16 levels of adherence to, xv minimum requirements for, expanding beyond, 45 processes for conformity to, 22, 2425 product and process validation, 4956, 51f, 52f product conformance and, 7778 systems approach to management and, 6974 ISO 9001:2008 Explained (Cianfrani, Tsiakals, and West), xv, 12, 39, 41 ISO 9004:2009 for conformity, 22, 2425 processes from, 2629, 27f questions for planning/conducting self-assessment to, 139150 ISO 9004:2009, Quality management systemsManaging for the sustained success of an organization, xv ISO-compliant process, implementing, 1216 change management and, 1516 continual improvement and, 1315 process effectiveness/efficiency and, 1213

154 Index

J
Juran, Joseph, 97, 102

P
partner development, 8 people organization and, 8 process use by, 20, 21f quality management system and, 127129 performance, improving, 128129 plan-do-check-act (PDCA), 61 prevention, 59, 98, 111, 119 preventive action, 5961, 61f, 104 developing, during planning process, 6061 ISO 9001:2008 references to, 59 problems, causes of, 62 processes change management, 1516 continual improvement, 1315, 14t, 15f control mechanisms of, 21, 21f defined, 20, 20f derived from excellence models, 2526 effectiveness, 1213, 4748 efficiency, 1213, 4748 from ISO 9004:2009, 2629, 27f resources people use within, 20, 21f support of, 21f well-managed example of, 24f process management. See also processes basics of, 2021, 20f, 21f ISO 9001:2008 needs of, 22, 2425 quality management system and, 1930 system management and, 2122, 23f, 24f product and process validation, ISO 9001:2008, 4956, 51f, 52f elements of, 5455 product design review, 5253, 52f validation, 52f, 53 verification, 52f, 53 product development, 53, 94, 105

L
leadership, providing, 7 lean, 97 learning, continual, 8

M
magical solutions, 9698 Malcolm Baldrige National Quality Award, 25 management, systems approach to, 6974 benefits of, 7172 big-picture thinking techniques, 71 complexity and, 7273 described, 6970 processes and, 7071 simplicity, steps to encourage, 7374 management responsibility (clause 5), 24, 27f management review, 36 role of, in quality management system, 129131 management systems, integrating, 2829 managers, top ISO 9001:2008 conformity and, 3 mission/vision statements and, 1011 quality professional and, 9 tasks of, 9 measurement process (clause 8), 25, 27f mission statements alignment and, 67, 69 revising, 1011

N
nonconformity, cost of, 42, 4344

O
objectives, alignment of, 7 organizational excellence models. See quality award models, self-assessment

 Index 155

product realization (clause 7), 24, 27f, 50, 51f, 5354, 94 purpose, providing, 7

Q
QMS. See quality management system (QMS) quality business relationship of, 99100 ISO 9000:2005 definition of, 128 working definition of, 128 quality assurance personnel executive management language and, 100 strategic planning and, 99 quality auditing. See auditing quality audits, internal, 3334 quality award models, selfassessment, 8290 conducting phase tasks of, 84, 90 examples of, 82 initiating, 83 maturity levels and, 85, 86t planning phase tasks of, 83 reporting phase tasks of, 8485, 8789, 89t step-by-step model of, 8587 quality management principles (QMPs), 610, 103 quality management system (QMS). See also process management auditing, 3145 building, 1930 creating sustainable, xv-xvi, xvif, 512 current system, understanding, 56 future of (see quality management system [QMS], future of) mission/vision statements and, 1011 processes for, 1112 quality management principles and, 610 revitalization of (see quality management system [QMS], revitalization of) structure and deployment of, 512

quality management system (QMS), future of actions to consider from report data for, 114115 ASQ 2011 study on, 113114, 114f communication challenge, 108112 Conference Board and, 112113, 113t cost optimization and, 118119 customer relationships and, 119120 global expansion and, 117118 human capital and, 116117 innovation and, 115116 overview, 107108 planning for, 112120 quality management system (QMS), revitalization of changing conditions and, 93, 124127, 126f employees role and, 132134 management review role and, 129131 people and, 127129 setting the bar and, 131132 shared vision and, 134135 stable state and, 123124 quality professional capabilities of, 101 communication challenges of, 108112 concepts of, 102

R
registration/regulatory compliance audits, 34 resource management (clause 6), 24, 27f results, focus on, 7 right-first-time (RFT), 61

S
second-party audits, 31 sector-specific standards, auditing and, 4243

156 Index

self-assessment conducting models for (see quality award models, self-assessment) described, 36, 8182 example, 8587 intent of, 3637 vs. internal auditing, 3638, 81 ISO 9004:2009, questions for planning/conducting, 139150 literature on, 37 maturity levels and, 85, 86t output of, 8182 questions asked and investigated in, 9092 reports, 8788, 89t strategic examples of, 98104 tactical examples of, 9298 setting the bar, quality management system and, 131132 shared vision, quality management system and, 134135 Shingo, Shigeo, 58 Six Sigma, 97 social responsibility, 67, 28 stable state, quality management system and, 123124 stakeholder development, 8 statistical process control (SPC), 97 strategic self-assessment examples, 98104 supplier audits, 34 supplier development, 8 sustaining growth, considerations for, 126f

systems approach to management, 6974 benefits of, 7172 big-picture thinking techniques, 71 complexity and, 7273 described, 6970 processes and, 7071 simplicity, steps to encourage, 7374

T
tactical self-assessment examples, 9298 third-party audits, 31 total quality management (TQM), 97

U
Unlocking the Power of Your QMS: Keys to Business Performance Improvement (West and Cianfrani), xv, 8

V
value stream mapping, 102103 vision, providing, 7 vision statements alignment and, 6769 revising, 1011

W
workforce competence, 28