Cracking the Case of ISO 9001:2015 for Service: A Simple Guide to Implementing Quality Management in Service Organizations
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About this ebook
It provides a simplified explanation of the clauses of ISO 9001:2015, including:
What’s required
Why to do it
Implementation tips
Questions to ask to assess conformity
Also included is a chapter that answers the question “Why do ISO 9001:2015?” and a chapter that summarizes the key differences with past editions of ISO 9001.
To assist the user in implementation of QMS processes, this guide also includes a chapter that describes 12 quality tools. For each tool, the authors describe (1) what it is, (2) where it’s used, (3) how it’s done, and (4) cautions to be considered when using the tool.
The contents of this book can help organizations save time in achieving compliance with the ISO 9001 requirements and also facilitate effective implementation. This has the potential to lower internal costs and to improve customer satisfaction.
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Cracking the Case of ISO 9001:2015 for Service - Charles A. Cianfrani
Cracking the Case of ISO 9001:2015 for Service
Also available from ASQ Quality Press:
Cracking the Case of ISO 9001:2015 for Manufacturing, Third Edition
Charles A. Cianfrani and John E. Jack
West
ISO 9001:2015 Explained, Fourth Edition
Charles A. Cianfrani, John E. Jack
West, and Joseph Tsiakals
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
The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing
J. B. Smith
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 Internal Audits Made Easy, Fourth Edition
Ann W. Phillips
ISO 9001:2015 for Small and Medium-Sized Businesses, Third Edition
Denise Robitaille
The Quality Toolbox, Second Edition
Nancy R. Tague
Root Cause Analysis: Simplified Tools and Techniques, Second Edition
Bjørn Andersen and Tom Fagerhaug
The ASQ Auditing Handbook, Fourth Edition
J.P. Russell, 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.
Cracking the Case of ISO 9001:2015 for Service
A Simple Guide to Implementing Quality Management in Service Organizations
Third Edition
Charles A. Cianfrani and John E. (Jack) West
ASQ Quality Press
Milwaukee, Wisconsin
American Society for Quality, Quality Press, Milwaukee 53203
© 2017 by ASQ
Library of Congress Cataloging-in-Publication Data
Names: Cianfrani, Charles A., author. | West, John E., 1944- author.
Title: Cracking the case of ISO 9001:2015 for service : a simple guide to
implementing quality management in service organizations / Charles A.
Cianfrani and John E. (Jack) West.
Description: Third edition. | Milwaukee, Wisconsin : ASQ Quality Press, 2016.
| Based on material originally published under title: Cracking the case of
ISO 9001:2000 for service. | Includes index.
Identifiers: LCCN 2016034070 | ISBN 9780873899086 (soft cover : alk. paper)
Subjects: LCSH: Quality control—Standards. | ISO 9001 Standard. | Service
industries—Quality control.
Classification: LCC TS156 .C73 2016 | DDC 658.5/620218—dc23
LC record available at https://lccn.loc.gov/2016034070
ISBN: 978-0-87389-908-6
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.
Publisher: Seiche Sanders
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.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.
To place orders or to request ASQ membership information, call 800-248-1946. Visit our website at http://www.asq.org/quality-press.
Table of Contents
Cracking the Case of ISO 9001:2015 for Service
List of Figures and Tables
Chapter 1: Why Do ISO 9001:2015?
Chapter 2: Key Differences with Past ISO 9001 Editions
Chapter 3: Principles and Key Concepts
Quality Management Principles
Customers—Customer Focus and Measuring Satisfaction
Process Approach—Activities, Process Management, and the Systems Approach to Management
Alignment—Quality Objectives, Process Measurement, and Communications
Continual Improvement
Process Control to Facilitate Learning, Innovation, and Improvement
Leadership and Involvement at All Levels
Vision and Mission
Chapter 4: What Are the ISO 9001:2015 Requirements and How Do We Comply?
Introduction
Clause 1 Scope
Clause 2 Normative References
Clause 3 Terms and Definitions
Clause 4 Context of the organization
Clause 4.1 Understanding the organization and its context
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 4.2 Understanding the needs and expectations of interested parties
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 4.3 Determining the scope of the quality management system
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 4.4 Quality management system and its processes
What Is the Requirement?
Why Do It?
Implementation tips
Questions to Ask to Assess Conformity
Clause 5 Leadership
Clause 5.1 Leadership and commitment
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 5.2 Policy
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 5.3 Organizational roles, responsibilities and authorities
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 6 Planning
Clause 6.1 Actions to address risks and opportunities
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
clause 6.2 Quality objectives and planning to achieve them
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 6.3 Planning of changes
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 7 Support
Clause 7.1 Resources
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 7.2 Competence
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 7.3 Awareness
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 7.4 Communication
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 7.5 Documented information
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8 Operation
Clause 8.1 Operational planning and control
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.2 Requirements for products and services
Clause 8.2.1 Customer communication
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.2.2 Determining the requirements for products and services
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.2.3 Review of the requirements for products and services
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.2.4 Changes to requirements for products and services
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
clause 8.3 Design and development of products and services
clause 8.3.1 General
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.3.2 Design and development planning
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.3.3 Design and development inputs
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.3.4 Design and development controls
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
clause 8.3.5 Design and development outputs
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.3.6 Design and development changes
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
clause 8.4 Control of externally provided processes, products and services
clause 8.4.1 General
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.4.2 Type and extent of control
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.4.3 Information for external providers
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.5 Production and service provision
clause 8.5.1 Control of production and service provision
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.5.2 Identification and traceability
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.5.3 Property belonging to customers or external providers
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.5.4 Preservation
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.5.5 Post-delivery activities
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
clause 8.5.6 Control of changes
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.6 Release of products and services
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 8.7 Control of nonconforming outputs
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 9 Performance evaluation
clause 9.1 Monitoring, measurement, analysis and evaluation
clause 9.1.1 General
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 9.1.2 Customer satisfaction
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
clause 9.1.3 Analysis and evaluation
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 9.2 Internal audit
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
clause 9.3 Management review
clause 9.3.1 General
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 9.3.2 Management review inputs
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Clause 9.3.3 Management review outputs
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
clause 10 Improvement
clause 10.1 General
What Is the Requirement?
Why Do It?
Implementation Tips
Clause 10.2 Nonconformity and corrective action
Clause 10.2.1 (Untitled clause)
What Is the Requirement?
Why Do It?
Implementation Tips
Clause 10.2.2 (Untitled Clause)
What Is the Requirement?
Why Do It?
Implementation Tips
Clause 10.3 Continual Improvement
What Is the Requirement?
Why Do It?
Implementation Tips
Questions to Ask to Assess Conformity
Annex A (Informative) Clarification of new structure, terminology and concepts
A.1 Structure and terminology
A.2 Products and services
A.3 Understanding the needs and expectations of interested parties
A.4 Risk-based thinking
A.5 Applicability
A.6 Documented information
A.7 Organizational knowledge
A.8 Control of externally provided processes, products and services
Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176