ISO 9000 Quality Systems Handbook: Increasing the Quality of an Organization’s Outputs

893 Pages·2017·7.4 MB·English

by  David Hoyle

David Hoyle’s latest work on this ISO 9000 handbook once again “cracks the code”,
encrypted by the ISO TC 176 authors and offers, actionable, pragmatic advice for users
and quality practitioners around the world on how to understand and effect the ISO 9000
family of documents. With so many competing publications on the subject, this 7th edition
should be the essential, go-to handbook for quality professionals seeking to understand
and benefi t from an ISO 9001 modelled quality system.
Sidney Vianna, Management System
Professional, DNV GL, USA
A must-have for anyone tasked with facilitating the creation and delivery of value to stake-
holders, David Hoyle’s staggeringly powerful latest edition of Quality Systems Handbook
expertly and thoroughly demystifi es the updated ISO 9000 Standards. An indispensable
tool for managing quality and successful certifi cation.
John Colebrook, Director, Enhanced Operating
Systems Ltd, New Zealand
A valuable resource that explores salient concepts arising from the ISO 9001:2015 stan-
dard in an unambiguous manner. David Hoyle using his inimitable step by step approach
demonstrates the applicability of quality management standard to any organisational con-
text. This book is defi nitely recommended reading for both academics and business lead-
ers seeking to gain an in depth understanding of quality management systems.
Dr Lowellyne James, Lecturer in Quality Management,
Robert Gordon University, IEMA Certifi cate in Sustainability
Strategy Programme Leader, Scotland
To be up-to-date with the latest in ISO 9000 Quality Systems (ISO9000:2015), this is the
defi nitive guide to refer to. David Hoyle’s 7th edition stays true to its purpose of ensuring
interpreting the Standard, comprehensible.
Christopher Seow, Visiting Lecturer “Six Sigma for Managers”
Cass Business School, City, University of London, UK
David Hoyle pulls no punches in this very comprehensive seventh edition of his ISO 9000
Handbook. Whether you are a scholar, business executive, quality manager, consultant or
a Certifi cation Body, this book is for you. He goes out of his way to change the miscon-
ception of what the ISO 9001:2015 standard is really all about. He meticulously explains
that it is aimed at improved performance and not just a set of requirements for compliance.
David convinces the reader that Quality should be managed as an integral part of every
business.
Paul Harding, Managing Director, South
African Quality Institute, South Africa
Yet again David Hoyle has produced another excellent book that explains the new stan-
dard and its requirements in straightforward terms. It is the book we have all been waiting
for that will help us implement the new Standard and will become the new bible for qual-
ity management Systems. If you follow the advice in Hoyle’s book you will not have any
issues when the auditor arrives at your door. It is suitable for all people involved in the
standard from company directors who need to know more about their responsibilities to
experienced and busy Quality Managers who need to implement and inform others about
the changes.
Rhian Newton, HSEQ Manager,
Morgan Advanced Materials, UK
The book does a great job of showing how a quality system built to the principles of ISO
9000 and conforming to the new ISO 9001:2015 requirements can be an integral part of
leadership’s strategic approach to running the business versus letting a quality manage-
ment system operate in a silo.
The book explores and explains the ISO9001:2015 requirements in a way that is easy
to follow yet at the same time deep and meaningful especially for those new concepts and
requirements such as leadership, context of the organization and managing risk. This feels
like a book I’ll keep referring to for many years to come.
Richard Allan, Director, Quality Assurance,
Kimberly-Clark Corporation, UK
ISO 9000 Quality Systems Handbook
Completely revised to align with ISO 9001:2015, this handbook has been the bible for
users of ISO 9001 since 1994, helping organizations get certifi ed and increase the quality
of their outputs.
Whether you are an experienced professional, a novice, or a quality management student
or researcher, this is a crucial addition to your bookshelf. The various ways in which require-
ments are interpreted and applied are discussed using published defi nitions, reasoned argu-
ments and practical examples. Packed with insights into how the standard has been used,
misused and misunderstood, ISO 9000 Quality Systems Handbook will help you to decide
if ISO 9001 certifi cation is right for your company and will gently guide you through the
terminology, requirements and implementation of practices to enhance performance.
Matched to the revised structure of the 2015 standard, with clause numbers included for
ease of reference, the book also includes:
• Graphics and text boxes to illustrate concepts, and points of contention;
• Explanations between the differences of the 2008 and 2015 versions of ISO 9001
• Examples of misconceptions, inconsistencies and other anomalies
• Solutions provided for manufacturing and service sectors.
This new edition includes substantially more guidance for students, instructors and man-
agers in the service sector, as well as those working with small businesses.
Don’t waste time trying to achieve certifi cation without this tried and trusted guide to
improving your business – let David Hoyle lead you towards a better way of thinking about
quality and its management and see the difference it can make to your processes and profi ts!
David Hoyle as a manager, consultant, author and mentor has been helping individuals
and organizations across the world understand and apply ISO 9001 effectively since its
inception in 1987. He has held senior positions in quality management with British Aero-
space and Ferranti International and worked with such companies as General Motors, the
UK Civil Aviation Authority and Bell Atlantic on their quality improvement programmes.
Although neither a member of ISO nor BSI technical committees, he has been a member
of the CQI for over 40 years and through his work with them built a network of like-
minded professionals including members of ISO and BSI technical committees, which
gave him privileged access to many reports, presentations and early drafts and thus gained
an insight into the thinking behind ISO 9001:2015.

ISO 9000 Quality Systems
Handbook
Increasing the Quality of an Organization’s
Outputs
Seventh Edition
David Hoyle
Seventh edition published 2018
by Routledge
2 Park Square, Milton Park, Abingdon, Oxon OX14 4RN
and by Routledge
711 Third Avenue, New York, NY 10017
Routledge is an imprint of the Taylor & Francis Group, an informa business
© 2018 David Hoyle
The right of David Hoyle to be identifi ed as author of this work has been
asserted by him in accordance with sections 77 and 78 of the Copyright,
Designs and Patents Act 1988.
All rights reserved. No part of this book may be reprinted or reproduced or
utilised in any form or by any electronic, mechanical, or other means, now
known or hereafter invented, including photocopying and recording, or in
any information storage or retrieval system, without permission in writing
from the publishers.
Trademark notice : Product or corporate names may be trademarks or
registered trademarks, and are used only for identifi cation and explanation
without intent to infringe.
First edition published by Butterworth-Heinemann 1994
Sixth edition published by Butterworth-Heinemann 2009 and by Routledge 2013
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library
Library of Congress Cataloging-in-Publication Data
Names: Hoyle, David, author.
Title: ISO 9000 quality systems handbook : using the standards as a framework
for business improvement / David Hoyle.
Description: Seventh edition. | Abingdonm, Oxon ; New York, NY : Routledge,
2017. | Includes bibliographical references and index.
Identifi ers: LCCN 2016056514 (print) | LCCN 2016057166 (ebook) | ISBN
9781138188631 (hardback : alk. paper) | ISBN 9781138188648 (pbk. : alk.
paper) | ISBN 9781315642192 (ebook) | ISBN 9781315642192 (eBook)
Subjects: LCSH: ISO 9000 Series Standards—Handbooks, manuals, etc. |
Quality control—Auditing—Handbooks, manuals, etc.
Classifi cation: LCC TS156.6 .H69 2017 (print) | LCC TS156.6 (ebook) |
DDC 658.5/620218—dc23
LC record available at https://lccn.loc.gov/2016056514
ISBN: 978-1-138-18863-1 (hbk)
ISBN: 978-1-138-18864-8 (pbk)
ISBN: 978-1-315-64219-2 (ebk)
Typeset in Times New Roman
by Apex CoVantage, LLC
Visit the companion website: http://www.routledge.com/cw/hoyle
Dedicated to my very dear friend and colleague, Tony Brown 1945–2016

Contents
Preface to the seventh edition xiii
PART 1
Introduction 1
1 Putting ISO 9001 in context 3
2 Comparison between 2008 and 2015 editions 19
3 How the 2015 version has changed misconceptions 37
Key messages from Part 1 48
PART 2
Anatomy and use of the standards 51
4 The ISO 9000 family of standards 53
5 A practical guide to using these standards 61
Key messages from Part 2 84
PART 3
Terminology 87
6 Quality 91
7 Requirements 102
8 Management system 108
9 Process and the process approach 126
10 Risk and opportunity 148
11 Interested parties and stakeholders 159
Key messages from Part 3 168