A Practical Field Guide for ISO 9001:2015

Erik V. Myhrberg

Description

The intent of this field guide is to assist organizations, step by step, in implementing a QMS in conformance with ISO 9001:2015, whether “from scratch” or by transitioning from ISO 9001:2008. Within the guide each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below. This book examines each sub-clause of clauses 4–10 of ISO 9001:2015, which contain the requirements, with a visual representation provided in flowchart format on the facing page.
This field guide will:
*Provide a user-friendly guide to ISO 9001:2015’s requirements for implementation purposes
*Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 9001:2015 implementation
*Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists
*Direct management on what it must do and should consider to satisfy ISO 9001:2015’s enhanced requirements and responsibilities for top management
*Depict step by step what must occur to create an effective, conforming QMS
What separates this field guide from most other books on ISO 9001:2015 and its implementation are the flowcharts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. As the flowcharts themselves can be overwhelming when you first look at them, a text box appears with each flow chart that explains pertinent facts and/or what the flowchart represents and how it is to be used.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Techniques
• Automatisation et Contrôle
• Total Quality Management
• Gestion et management
• ISO 9000
• International Organization for Standardization
• Economics
• QMS
• ISO 9001

Informations

• Publié par: ASQ Quality Press
• Date de parution: 03 octobre 2016
• Nombre de lectures: 1
• EAN13: 9781953079411
• Langue: English
• Poids de l'ouvrage: 3 Mo

Extrait

A PRACTICAL FIELD GUIDE
FOR ISO 9001:2015Also by Erik V. Myhrberg:
The ISO 9001:2015 QMS “Bluesheet” ©2015
The ISO 14001:2015 EMS “Greensheet” ©2015
The OHSAS 18001:2007 HSMS “Redsheet” ©2007
The ISO 27001:2013 ISMS “Goldsheet” ©2013
Also available from ASQ Quality Press:
A Practical Field Guide for AS9100C, Second Edition
Erik V. Myhrberg, Dawn Holly Crabtree, and Rudy “RE” Hacker
A Practical Field Guide for ISO 13485
Erik V. Myhrberg
The ISO 9001:2015 Implementation Handbook: Using the Process Approach to Build a Quality Management System
Milton P. Dentch
ISO Lesson Guide 2015: Pocket Guide to ISO 9001:2015, Fourth Edition
J.P. Russell
How to Audit ISO 9001:2015: A Handbook for Auditors
Chad Kymal
How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA
Requirements: A Comprehensive Guide to Designing a Process-Based Document Control System
Stephanie L. Skipper
ISO 9001:2015 Explained, Fourth Edition
Charles A. Cianfrani, John E. “Jack” West, and Joseph Tsiakals
ISO 9001:2015 Internal Audits Made Easy, Fourth Edition
Ann W. Phillips
ISO 9001:2015 for Small and Medium-Sized Businesses, Third Edition
Denise Robitaille
The Certified Quality Engineer Handbook, Third Edition
Connie M. Borror, editor
Root Cause Analysis: Simplified Tools and Techniques, Second Edition
Bjørn Andersen and Tom Fagerhaug
The Certified Manager of Quality/Organizational Excellence Handbook, Third 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.A PRACTICAL FIELD GUIDE
FOR ISO 9001:2015
• Management Guidance
• Revision and Update Information
• Implementation Support
• Documentation Assistance
• Auditing Technique
4.1, 4.2, 4.3
Establish
context,
define relevant 10 Continual improvement
interested
parties and
scope of QMS
5 Leadership
4.1 General and
process approach
Customers and
other relevant Customer9 Performance
6 Planninginterested satisfactionevaluation
parties *
Products
Requirements Inputs Outputs and
8 Operations services
7 Support processes
Erik V. Myhrberg, PhD
ASQ Quality Press
Milwaukee, WisconsinAmerican Society for Quality, Quality Press, Milwaukee 53203
© 2017 by ASQ
All rights reserved. Published 2016
Printed in the United States of America
22 21 20 19 18 17 16 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Names: Myhrberg, Erik V., author.
Title: A practical field guide for ISO 9001:2015 : management guidance,
revision and update information, implementation support, documentation
assistance, auditing technique / Dr. Erik V. Myhrberg.
Description: Milwaukee, Wisconsin : ASQ Quality Press, [2016]
Identifiers: LCCN 2016037741 | ISBN 9780873899406 (soft cover, ring bound :
alk. paper)
Subjects: LCSH: ISO 9001 Standard.
Classification: LCC TS156.17.I86 M94 2016 | DDC 657/.45--dc23
LC record available at https://lccn.loc.gov/2016037741
ISBN: 978-0-87389-940-6
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.
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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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To place orders or to request ASQ membership information, call 800-248-1946. Visit our website at
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Printed on acid-free paperTo my blessed family:
Marcena, Brandon, and Heather
To my diligent colleagues:
David R. and Joseph R., and Joe L.
To my professional associations:
IRCA, IEMA, ASQ 
 
 
 
 
 
TABLE OF CONTENTS
Introduction                                                                    ix
How to Use This Field Guide                                                       xi
Annex SL                                                                       xv
Clause 4: Context of the Organization                                              1
4.1 Understanding the organization and its context .................................. 2
4.2 Understanding the needs and expectations of interested parties ...................... 4
4.3 Determining the scope of the quality management system ......................... 6
4.4 Quality management system and its processes ................................... 8
Revisions to ISO 9001:2008 in ISO 9001:2015 ..................................... 10
Clause 5: Leadership                                                            13
5.1 Leadership and commitment ................................................. 14
5.1.1 General .............................................................. 14
5.1.2 Customer focus ........................................................ 16
5.2 Policy ................................................................... 18
5.3 Organizational roles, responsibilities and authorities .............................. 20
Revisions to ISO 9001:2008 in ISO 9001:2015 ..................................... 22
Clause 6: Planning                                                              25
6.1 Actions to address risks and opportunities ...................................... 26
6.1.1 ..................................................................... 26
6.1.2 28
6.2 Quality objectives and planning to achieve them ................................. 30
6.2.1 30
6.2.2 30
6.3 Planning of changes ....................................................... 33
Revisions to ISO 9001:2008 in ISO 9001:2015 ..................................... 35
vii 
 
 
 
 
 
 
 
viii Table of Contents
Clause 7: Support                                                               39
7.1 Resources ................................................................ 40
7.1.1 General .............................................................. 40
7.1.2 People ............................................................... 42
7.1.3 Infrastructure ......................................................... 44
7.1.4 Environment for the operation of processes .................................. 46
7.1.5 Monitoring and measuring resources ....................................... 48
7.1.6 Organizational knowledge ............................................... 50
7.2 Competence .............................................................. 52
7.3 Awareness ............................................................... 54
7.4 Communication ........................................................... 56
7.5 Documented information .................................................... 58
7.5.1 General 58
7.5.2 Creating and updating .................................................. 60
7.5.3 Control of documented information ........................................ 62
Revisions to ISO 9001:2008 in ISO 9001:2015 ..................................... 64
Clause 8: Operation                                                             71
8.1 Operational planning and control ............................................. 72
8.2 Requirements for products and services 74
8.3 Design and development of products and services ................................ 77
8.4 Control of externally provided processes, products and services ..................... 81
8.5 Production and service provision 85
8.6 Release of products and services 90
8.7 Control of nonconforming outputs ............................................ 92
Revisions to ISO 9001:2008 in ISO 9001:2015 ..................................... 94
Clause 9: Performance evaluation                                                  107
9.1 Monitoring, measurement, analysis and evaluation ................................ 108
9.2 Internal audit ............................................................. 112
9.3 Management review ....................................................... 115
Revisions to ISO 9001:2008 in ISO 9001:2015 119
Clause 10: Improvement                                                          129
10.1 General ................................................................ 130
10.2 Nonconformity and corrective action ......................................... 132
10.3 Continual improvement .................................................... 135
Revisions to ISO 9001:2008 in ISO 9001:2015 ..................................... 137
ISO 9001:2015 Documented Information Requirements                                  141
ISO 9001:2015 to ISO 9001:2008—Correlation Matrix 142
ISO 9001:2008 to ISO 9001: 2015—Correlation Matrix                                 145
Sources of Information                                                            149INTRODUCTION
he release of the most current version of ISO 9001 now reflects even better the ever changing
worldwide nature of business. Companies globally have, for the most part, moved with these Tchanges. From the original 1987 version to the latest 2015 version, the management standard
continues to add value to organizations.
More than 25 years have passed (and over 155 projects) since I first became aware of, and started
using, the ISO 9000 standards. So much has changed and evolved during this time: the advent of the ISO
14001 and ISO 27001 management standards, the addition and deletion of standards within the ISO 9000
series, and the creation of a host of industrial and sector-specific standards and “reports” based on ISO
9001, such as AS9100 for aer