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The 2015 edition of ISO 9001 has been modernized to update terminology and content to meet current and anticipated user needs. The major emphasis of ISO 9001:2015 is still consistent provision of products and services that meet customer and applicable statutory and regulatory requirements.
This book explains the meaning and intent of the requirements of ISO 9001:2015 and discusses the requirements as they relate to each of the product categories. Where appropriate, it includes an elaboration of why the requirements are important. It also includes typical audit-type questions that an organization may consider to assess conformity to internal needs and ISO 9001 requirements. Recommendations for implementation are also included.
This book addresses the needs of:
Users and organizations seeking a general understanding of the contents of ISO 9001:2015
Users and organizations desiring guidance to ensure their ISO 9001:2015 QMS meets the new version requirements
Users and organizations considering the use of ISO 9001:2015 as a foundation for the development of a comprehensive QMS
Educators who require a textbook to accompany a training class or course on ISO 9001:2015
Auditors who desire to increase their level of auditing competence
Authors Cianfrani and West, members of the expert group that developed ISO 9001:2015, strive to provide a context for all requirements to enable you to develop and deploy processes that will strengthen your QMS. Getting or retaining a certificate is not the real objective. Satisfied customers and organizational sustainability should be primary objectives for the organization.
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Date de parution

21 septembre 2015

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3

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9781953079749

Langue

English

ISO 9001:2015 Explained
Fourth Edition
Charles A. Cianfrani
John E. (Jack) West
ASQ Quality Press
Milwaukee, Wisconsin
American Society for Quality, Quality Press, Milwaukee 53203
© 2015 by ASQ
All rights reserved.
Library of Congress Cataloging-in-Publication Data
Cianfrani, Charles A., author.
ISO 9001:2015 explained / Charles A. Cianfrani, John E. (Jack) West.
pages cm
Includes index.
ISBN 978-0-87389-901-7 (alk. paper)
1. ISO 9001 Standard. 2. Quality control—Standards. I. West, Jack, 1944– author. II. Title.
TS156.6.C45 2016
658.5′620218—dc23
2015033095
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.
Publisher: Lynelle Korte
Acquisitions Editor: Matt Meinholz
Managing Editor: Paul Daniel O’Mara
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.
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Preface
T he ISO 9000 series of quality management system (QMS) standards was initially issued in 1987 and reissued with minor revisions in 1994. A major revision was issued in 2000 to update the standards and to make the documents more user-friendly. ISO 9001:2008 was the fourth edition of ISO 9001.
The 2015 edition of ISO 9001 has been modernized to update terminology and content to meet current and anticipated user needs. The major emphasis of ISO 9001:2015 is still consistent provision of products and services that meet customer and applicable statutory and regulatory requirements. The latest edition of ISO 9001 incorporates directly or indirectly all the requirements of its predecessor but the language may appear peculiar or unfamiliar. It also contains requirements that may be new for many organizations. The old, the new, and the repackaged requirements are addressed in this book.
A few areas that should receive your particular attention as you address the requirements of ISO 9001:2015 include: Understanding the needs of the customer including consideration of internal and external issues and the needs and expectations of interested parties beyond a direct customer Considering processes related to risks and opportunities Understanding needs, meeting requirements, and monitoring information related to customer satisfaction Use of a process approach, which considers all work in terms of suppliers, inputs, processing activities, process interactions, resources, outputs, and customers Managing a system of effective processes rather than documenting the system in procedures Emphasizing the role of top management Setting measurable objectives and measuring product and process performance Analyzing and using data to define opportunities for improvement Continual improvement of processes and of QMS effectiveness Use of wording that can be understood in all product sectors—not just hardware New terminology especially for documented information The lack of specific requirements for documented information in several places The appearance of the elimination of preventive action (which has been replaced by the introduction of risk-based thinking)
All of the above are addressed in detail in this book. As was our objective in the previous three editions, we strive to provide a context for all requirements to enable you to develop and deploy processes that will strengthen your QMS. Getting or retaining a certificate is not the real objective. Satisfied customers and organizational sustainability should be primary objectives for the organization.
This book addresses the needs of: Users and organizations seeking a general understanding of the contents of ISO 9001:2015 Users and organizations desiring guidance to ensure their ISO 9001:2015 QMS meets the new version requirements Users and organizations considering the use of ISO 9001:2015 as a foundation for the development of a comprehensive QMS Educators who require a textbook to accompany a training class or course on ISO 9001:2015 Auditors who desire to increase their level of auditing competence
This book explains the meaning and intent of the requirements of ISO 9001:2015 and discusses the requirements as they relate to each of the product categories. Where appropriate, it includes an elaboration of why the requirements are important. It also includes typical audit-type questions that an organization may consider to assess conformity to internal needs and ISO 9001 requirements.
Recommendations for implementation are also included. Each clause has a section on tips for implementation. New tips have been added as appropriate to accommodate new terminology and requirements. ISO 9001:2015 provides requirements for what activities and processes are needed; it does not tell the user how to carry out these requirements. Therefore, the authors have included some recommendations for implementation actions that have proven to be successful. It should be recognized that this implementation guidance may go beyond the requirements of ISO 9001:2015. It is provided because much of what is needed for a successful QMS involves how the requirements are implemented, not the requirements themselves.
There is also a new chapter, “Integrating the Process Approach and Systems Thinking.”
The contents of ISO 9001:2015 have been paraphrased in this book. Paraphrased text by its very nature can introduce differences in understanding and interpretation. This book should be used in conjunction with: ISO 9001:2015 Quality management systems—Requirements ISO 9000:2015 Quality management systems—Fundamentals and vocabulary
This book is intended to facilitate an understanding of the process approach and related systems thinking and how to apply it in any organization to create, deploy, and improve a QMS. The intended outcome should be a QMS that achieves internal operating effectiveness and improved performance as viewed by customers and other interested parties.
For simplicity, the book often refers to specific editions of ISO 9001 by the year only (i.e., ISO 9001:2015 is referred to as 2015).



1
ISO 9001:2015: What’s New and How to Get Started on the ISO 9001:2015 Journey
Plus ça change, plus c’est la même chose. (The more things change, the more they stay the same.)
—French proverb
Ah, is it just me or does anybody see
The new improved tomorrow isn’t what it used to be
Yesterday keeps comin’ ’round, it’s just reality
It’s the same damn song with a different melody
—Jon Bon Jovi
Background
Before addressing ISO 9001:2015, the fifth edition of ISO 9001, let us consider the events that brought us from the first edition, in 1987, to the current time.
In 1987 the first edition of ISO 9001 was published by the International Organization for Standardization (ISO). That standard created a common worldwide language for quality assurance. Two additional International Standards were published at the same time that were derivatives of, and less comprehensive than, ISO 9001. The intent at that time was to provide a global set of minimum requirements for quality systems. If an organization could demonstrate conformity with this minimum set of requirements, its customers anywhere in the world could have confidence in the products and services that the organization provided, and international trade would be facilitated.
The first edition did not include the words “quality assurance” or “quality management” in its title—just “quality systems.” Over the years the standard has changed in many ways in both its form and content, but its essence and intent have remained the same—the articulation of a minimum set of requirements that an organization should consider in structuring and deploying its quality management system (QMS). The second edition of ISO 9001 was published in 1994, the third edition in 2000, and the fourth in 2008.
In its initial release, ISO 9001 was created as one element of a family of standards—ISO 9000, ISO 9001, and ISO 9004. ISO 9001 was a requirements document, meaning that it stated requirements. ISO 9000 and ISO 9004 were guidance documents that did not contain requirements. The primary use of ISO 9000 was as a quality dictionary, although it contained much additional quality-related information. ISO 9004 was a guideline document that provided its readers with areas and processes an organization could consider to expand the breadth and depth of its quality system. ISO 9004 has always been intended to serve as a stepping-stone for organizations that desired to expand their quality systems beyond a minimum set of processes to world-class levels of quality.
We now have the fifth edition of ISO 9001 available to us.
What Is New (if Anything) in ISO 9001:2015?
The question many of us ask about ISO 9001:2015 is “Are there any new requirements in ISO 9001:2015?” The answer to this question is “It depends.” If an organization has a QMS designed and deployed to meet or exceed the intent of the requirements contained in

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