ISO 9001:2015 in Plain English

Craig Cochran

• Publisher: Paton Professional
• Year: 2015
• Print ISBN: 9781932828726
• eBook ISBN: 9781932828207
• Topic: Business
• Subtopic: Operations
• Index: Business

Bestselling author Craig Cochran has translated ISO 9001: 2015 into plain English that anyone can understand. Cochran has written a comprehensive yet easily understandable guide to ISO 9001: 2015. ISO 9001: 2015 in Plain English was written so that anyone at any level of the organization can get to the heart of the standard's requirements and how they apply to the organization quickly and simply.This straightforward book is ideal for people who are new to ISO 9001: 2015, experienced ISO coordinators who want to get more out of an established system as they transition to the new standard, and for employees who just need a basic understanding of what ISO 9001: 2015 is and how it applies to them.Cochran explains each of ISO 9001: 2015's sections and clauses using real-world examples and frequently asked questions.

ISO 9001:2015
in Plain English

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Order these and other titles online at www.patonprofessional.com.

ISO 9001:2015
in Plain English

Craig Cochran

Chico, California

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© 2015 by Craig Cochran. All rights reserved.
Printed in the United States of America

20 19 18 17 16 15 10 9 8 7 6 5 4 3 2 1

ISBN: 978-1-932828-72-6

Library of Congress Cataloging in Publication Data on File

Notice of Rights

No part of this work covered by the copyright herein may be reproduced or used in any form or by any means—graphic, electronic, or mechanical, including photocopying, recording, taping, or information storage and retrieval systems—without permission in writing from Paton Professional.

Notice of Liability

The information in this book is distributed on an “as is” basis, without warranty. Although every precaution has been taken in the preparation of the book, neither the author nor Paton Professional shall have any liability to any person or entity with respect to any loss or damage caused or alleged to be caused directly or indirectly by the information contained in this book.

Staff

Editor & Publisher: Scott M. Paton
Assistant Editors: Daniel Taylor and Laura Smith
Book design: Anita Jovanovic
Cover design: Miguel Kilantang

To Muriel, a model of patience and love

Contents

Chapter 1

Introduction

Chapter 2

ISO 9001:2015 Section 4, Context of the Organization

Chapter 3

ISO 9001:2015 Section 5, Leadership

Chapter 4

ISO 9001:2015 Section 6, Planning

Chapter 5

ISO 9001:2015 Section 7, Support

Chapter 6

ISO 9001:2015 Section 8, Operation

Chapter 7

ISO 9001:2015 Section 9, Performance Evaluation

Chapter 8

ISO 9001:2015 Section 10, Improvement

Chapter 9

Conclusion: Implementing ISO 9001:2015

APPENDIX A

Additional ISO 9001:2015 Requirements Beyond ISO 9001:2008

APPENDIX B

Validation of Processes When Output Cannot Be Verified

APPENDIX C

Work Instructions

INDEX

This book is not intended as a replacement for the ISO 9001:2015 standard.

If you haven’t read the standard, do so—now!

It’s also a good idea to read ISO 9000:2015, which is the normative reference for ISO 9001:2015.

You can buy them both at www.iso.org or

your country’s national standards body.

Chapter 1

Introduction

ISO 9001 might be the most confusing document in business history. I first became aware of the standard in the late 1980s when my manager handed it to me and said, “See if you can figure this thing out. Our plant has to get certified.” I took the document back to my desk and attempted to read it. The first attempt was a failure. On the second attempt, I got a little further. On the third attempt, I think I read the whole thing, but I still wasn’t sure what it said. All I could remember was “blah, blah, blah… quality system.” And we were supposed to get certified to this? Impossible.

We did get certified, of course. It was the first step in a long relationship with ISO 9001. With every subsequent experience, there were new discoveries and revelations, and it was common to hear employees say that they wished the standard was easier to understand. What lies at heart of all this confusion? The crux of the problem is that ISO 9001 was written to apply to any kind of organization. When you write a document that’s applicable to everyone, you end up with something that’s not very well suited to anyone. Another problem is that ISO 9001 was written by committee. There were a lot of hands stirring the pot, so the resulting standard is more complex than it would be had it been the work of a single person.

Before we get too much further, let’s rewind with some basics. ISO 9001 is an international quality management system (QMS) standard. It presents fundamental management and quality assurance practices that can be applied by any organization. The requirements represent an excellent foundation of planning, control, and improvement for just about any enterprise. Without a QMS, organizations have little chance of sustaining any improvements or innovations they might realize. I believe that ISO 9001 is a basic model for managing any enterprise. It goes beyond what many people traditionally consider “quality.” In fact, I avoid using the word quality in relation to the standard anytime I can get away with it. ISO 9001 is ...

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