ISO 9001:2015 In Brief

283 Pages·2016·9.937 MB·English

by  Ray Tricker

6762 ISO 9001 2015 IN BRIEF-PT_156x234 mm 21/05/2016 14:12 Page i
ISO 9001:2015 in Brief
ISO 9001:2015 in Briefprovides an introduction to quality management systems
for students, newcomers and busy executives, with a user friendly, simplified
explanation of the history, requirements and benefits of the new standard.
This short, easy-to-understand reference tool also helps organisations to quickly
set up an ISO 9001:2015 compliant Quality Management System for themselves
at minimal expense and without high consultancy fees.
Now in its fourth edition, ISO 9001:2015 in Brief consists of a number of
chapters covering topics like:
(cid:129) What is Quality? – An introduction to the requirements and benefits of
quality, quality control and quality assurance
(cid:129) What is a QMS? – The structure of a Quality Management System and
associated responsibilities
(cid:129) Who produces Quality Standards? – An opportunity to see how interlinked
the various Standards Bodies are today
(cid:129) What is ISO 9001:2015? –The background to this particular standard, how
it has grown and developed over the years and what ‘Annex SL’ is all about
(cid:129) What other standards are based on ISO 9001:2015? – Details of other standards
that replicate or are broadly based on ISO 9001:2015
(cid:129) What to do once your QMS is established – Process improvement tools,
internal auditing and the road to ISO 9001:2015 certification
This is supported by:
(cid:129) A summary of the requirements of ISO 9001:2015, including an overview of
the content of the various clauses and sub-clauses, the likely documentation
required and how these would affect an organization. A cross-reference to the
previous ISO 9001:2008 clauses is also provided as well as a complete
bibliography and glossary.
Ray Tricker(MSc, IEng, CQP-FCQI, FIET, FCMI, FIRSE) is currently working
as the Senior Management Consultant for Herne European Consultancy Ltd –a
company specialising in offering organisations access to a range of highly skilled
and specialist consultants to help these companies enhance their business
performance.
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‘This common sense guide gives the reader an understanding of the history of
Quality Management Systems. Ray then breaks down the changes between ISO
9001:2008 and ISO 9001:2015 using easy to understand explanations and charts.’
–D.M. Belair, CAO, Kawartha Controls
‘I have absolutely no hesitation in recommending this book to any business or
person wanting to understand ISO 9001:2015 processes and procedures. The book
is an excellent reference tool and is to the point. The material’s very well explained,
presented and is an enjoyable read. It delivers exactly what it says it will –It’s a
short, easy-to-understand reference tool.’
–Szilvia Parkinson, Plantastic Rail LTD. UK
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ISO 9001:2015
in Brief
Fourth edition
Ray Tricker
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First published 2001 by Butterworth-Heinemann
Reprinted 2001, 2002
Second edition 2005 by Elsevier
Third edition 2009 by Herne
Fourth edition 2016 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
© 2001 and 2016 Ray Tricker
The right of Ray Tricker to be identified 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.
Every effort has been made to contact copyright holders for their
permission to reprint material in this book. The publishers would be
grateful to hear from any copyright holder who is not here acknowledged
and will undertake to rectify any errors or omissions in future editions of
this book.
Trademark notice: Product or corporate names may be trademarks or
registered trademarks, and are used only for identification and
explanation without intent to infringe.
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: Tricker, Ray, author.
Title: ISO 9001:2015 in brief / Ray Tricker.
Description: Fourth edition. | Abingdon, Oxon ; New York, NY :
Routledge, 2015. | Includes bibliographical references.
Identifiers: LCCN 2015046524| ISBN 9781138025851 (hardback) | ISBN
9781138025868 (pbk.) | ISBN 9781315774831 (ebook)
Subjects: LCSH: ISO 9001 Standard. | Quality control—Standards. |
Manufactures—Quality control—Evaluation.
Classification: LCC TS156.17.I86 T75 2015 | DDC 658.4/013—dc23
LC record available at http://lccn.loc.gov/2015046524
ISBN: 978-1-138-02585-1 (hbk)
ISBN: 978-1-138-02586-8 (pbk)
ISBN: 978-1-315-77483-1 (ebk)
Typeset in Minion Pro and Optima
by Florence Production Ltd, Stoodleigh, Devon, UK
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To my Grandsons
Kenneth, Joseph and James
In the hope that this book may prove
useful to them in their future chosen careers
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Contents
About the author xiii
Foreword xv
Preface xvii
1 What is quality? 1
1.1 But who is responsible for managing quality in an organisation? 5
1.2 And so what is the difference between a product and a service? 5
1.3 What about Quality Control and Quality Assurance? 6
1.3.1 Quality Control 7
1.3.2 Quality Assurance 7
2 What is a Quality Management System? 9
2.1 What are the requirements of a Quality Management
System? 17
2.2 What are the costs and benefits of having a Quality
Management System? 20
2.3 What is a Quality Manual? 23
2.3.1 What goes into a Quality Manual? 24
2.3.2 What does each part of the Quality Manual do? 26
2.4 What is a Quality Policy? 26
2.4.1 Mission Statements 27
2.4.2 Corporate policy statement 28
2.4.3 Process-specific policies 28
2.4.4 How to set quality objectives 30
2.4.5 How to go about setting measurable objectives 32
2.4.6 Fancy a RUMBA? 33
2.5 What is a QualityProcess? 33
2.5.1 The process approach 35
2.5.2 Core Business Process 36
2.5.3 What types of Core Processes would a business require? 38
2.5.4 Supporting processes 40
2.5.5 Inter-relationship of process documentation 44
2.5.6 The hierarchy of processes 45
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viii Contents
2.6 What is a Quality Plan? 46
2.6.1 What should be covered by a Quality Plan? 49
2.6.2 Management responsibility 49
2.6.3 Contract review 50
2.6.4 Design control 50
2.6.5 Documentation 50
2.6.6 Purchasing 50
2.6.7 Customer-supplied products and services 50
2.6.8 Product and service identification and traceability 51
2.6.9 Process control 51
2.6.10 Inspection and testing 51
2.6.11 Inspection, measuring and test equipment 51
2.6.12 Nonconforming products and services 52
2.6.13 Other considerations 52
2.7 What is a Quality Procedure? 53
2.7.1 What is the best way to write a Quality Procedure? 53
2.7.2 What should go into a Quality Procedure? 54
2.8 What is a Work Instruction? 58
2.8.1 What should go into a Work Instruction? 60
2.8.2 How many Work Instructions can I have? 61
2.9 Who controls quality in an organisation? 61
2.9.1 Who has overall responsibility? 61
2.9.2 Management responsibilities 62
2.9.3 The Quality Management Team 62
2.9.4 The Staff 64
2.10 How quality helps during the life cycle of products and services 64
2.10.1 Design stage 66
2.10.2 Manufacturing stage 67
2.10.3 Acceptance stage 67
2.10.4 In-service stage 68
2.10.5 End-of-life stage 68
2.11 What are the purchaser’s responsibilities? 70
2.12 What are the supplier’s responsibilities? 71
2.13 Quality Management and computer technology 73
3 The history of quality standards 77
3.1 1979 – BS 5750:1979 Parts 1, 2 and 3 81
3.2 1981–1986 85
3.3 1987 – ISO 9000:1987 Parts 1, 2 and 3 85
3.4 1994 – BS EN ISO 9000:1994 86
3.5 2000 – ISO 9001:2000 87
3.6 2008 – ISO 9001:2008 92
3.7 2015 – ISO 9001:2015 93
3.8 So what has changed? 94
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Contents ix
4 Who produces quality standards? 97
4.1 Who and what is ISO? 99
4.2 Who and what is the IEC? 101
4.3 Who and what is the ITU? 102
4.4 How important is the work of all these committees? 103
4.5 Military standards 104
4.6 National standards 104
5 A brief summary of ISO 9001:2015 109
5.1 Background reminder 110
5.2 Why has ISO 9001 been revised? 111
5.3 How are these standards revised? 112
5.4 What effect did this revision have on ISO 9001? 114
5.4.1 Other changes 114
5.5 What is Annex SL? 116
5.5.1 What is the new structure of Annex SL? 119
5.5.2 What is the current status of Annex SL revisions? 121
5.6 But what exactly is meant by the ‘ISO 9000 family of
standards’? 122
5.6.1 ISO 9000:2015 Quality Management Systems:
Fundamentals and vocabulary 123
5.6.2 ISO 9004:2009 Managing for the sustained success of
an organisation. A quality management approach 124
5.6.3 ISO 9001:2008 Quality Management Systems:
Requirements 125
5.7 The seven principles of management 126
5.7.1 The Process Model 129
5.8 What is the new structure of ISO 9001? 130
5.9 What are the major clause changes seen in ISO 9001:2015? 133
5.9.1 Are there any other significant changes? 133
5.9.2 What about the revised duties of Top Management? 136
6 What other standards are based on ISO 9001:2015? 139
6.1 Aerospace 143
6.2 Auditing management systems 143
6.3 Automotive industry 143
6.4 Computer software 143
6.5 Crop production 143
6.6 Data 144
6.7 Education 144
6.8 Electoral organisations 144
6.9 Energy management systems 144
6.10 Explosive atmospheres 144