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: 0
• EAN13: 9781953079428
• Langue: English

Extrait

A PRACTICAL FIELD GUIDE FOR ISO 9001:2015
Also 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

Erik V. Myhrberg, PhD
ASQ Quality Press Milwaukee, Wisconsin
American Society for Quality, Quality Press, Milwaukee 53203 © 2017 by ASQ All rights reserved. Published 2016
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 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.
Acquisitions Editor: Matt T. 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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To place orders or to request ASQ membership information, call 800-248-1946. Visit our website at http:// www.asq.org/quality-press .


To 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 How to Use This Field Guide Annex SL
Clause 4: Context of the Organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
Revisions to ISO 9001:2008 in ISO 9001:2015
Clause 5: Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
Revisions to ISO 9001:2008 in ISO 9001:2015
Clause 6: Planning
6.1 Actions to address risks and opportunities
6.1.1
6.1.2
6.2 Quality objectives and planning to achieve them
6.2.1
6.2.2
6.3 Planning of changes
Revisions to ISO 9001:2008 in ISO 9001:2015
Clause 7: Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
Revisions to ISO 9001:2008 in ISO 9001:2015
Clause 8: Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
Revisions to ISO 9001:2008 in ISO 9001:2015
Clause 9: Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
Revisions to ISO 9001:2008 in ISO 9001:2015
Clause 10: Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Revisions to ISO 9001:2008 in ISO 9001:2015
ISO 9001:2015 Documented Information Requirements ISO 9001:2015 to ISO 9001:2008—Correlation Matrix ISO 9001:2008 to ISO 9001:2015—Correlation Matrix Sources of Information
Introduction
T 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 changes. 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 aerospace and ISO 13485 for medical devices.
Even with all this progress, the fundamental use of the ISO 9000 series has not changed. Companies, teams, and individuals are still trying to meet customer expectations, worldwide competition still drives the need for innovation, and internal process pressures still demand continual improvement in order for companies to remain viable.
This field guide has been created in order to foster an inner reliance between senior management, middle management, functional teams, and the individual. Users of the field guide will find within it practical tools, tips, and techniques useful not only for implementing a quality management system but also for maintaining one.
Per the standard, one of the key purposes of a quality management system is to act as a preventive tool. Consequently, this international standard does not have a separate clause or sub-clause on preventive action. The concept of preventive action is expressed through the use of risk-based thinking in formulating quality management system requirements .
The risk-based thinking applied in this international standard has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements. There is greater flexibility than in ISO 9001:2008 in the requirements for processes, documented information, and organizational responsibilities. Indeed, this is already the century of international standards.
The revised ISO 9001:2015 series of standards is both useful to the organization and here to stay. May this operational field guide serve your organization well!
Erik V. Myhrberg
How to Use This Field Guide
T he 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. In keeping with ISO 9000:2015’s definition of quality as the “degree to which a set of inherent characteristics of an object fulfils requirements,” I have identified the requirements and inherent characteristics (distinguishing features) for this field guide. 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.
Requirements (or What the Field Guide Will Do)
• 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