ISO 9000 Quality Systems Handbook-updated for the ISO 9001: 2015 standard : Increasing the Quality of an Organization’s Outputs book cover
7th Edition

ISO 9000 Quality Systems Handbook-updated for the ISO 9001: 2015 standard
Increasing the Quality of an Organization’s Outputs

ISBN 9781138188648
Published July 17, 2017 by Routledge
892 Pages 101 B/W Illustrations

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Book Description

Completely revised to align with ISO 9001:2015, this handbook has been the bible for users of  ISO 9001 since 1994, helping organizations get certified and increase the quality of their outputs.

Whether you are an experienced professional, a novice, or a quality management student or researcher, this is a crucial addition to your bookshelf. The various ways in which requirements are interpreted and applied are discussed using published definitions, reasoned arguments and practical examples.  Packed with insights into how the standard has been used, misused and misunderstood, ISO 9000 Quality Systems Handbook will help you to decide if ISO 9001 certification is right for your company and will gently guide you through the terminology, requirements and implementation of practices to enhance performance.

Matched to the revised structure of the 2015 standard, with clause numbers included for ease of reference, the book also includes:

  • Graphics and text boxes to illustrate concepts, and points of contention;
  • Explanations between the differences of the 2008 and 2015 versions of ISO 9001;
  • Examples of misconceptions, inconsistencies and other anomalies;
  • Solutions provided for manufacturing and service sectors.

This new edition includes substantially more guidance for students, instructors and managers in the service sector, as well as those working with small businesses.

Don’t waste time trying to achieve certification without this tried and trusted guide to improving your business – let David Hoyle lead you towards a better way of thinking about quality and its management and see the difference it can make to your processes and profits!

Table of Contents


Preface to the Seventh Edition

Part 1 Introduction

Chapter 1 Putting ISO 9001 in context

Chapter 2 Comparison between 2008 and 2015 editions

Chapter 3 How the 2015 version has changed misconceptions

Key messages from Part 1

Part 2 Anatomy and use of the standards

Chapter 4 The ISO 9000 family of standards

Chapter 5 A practical guide to using these standards

Key messages from part 2

Part 3 Terminology

Chapter 6 Quality

Chapter 7 Requirements

Chapter 8 Management System

Chapter 9 Process and the process approach

Chapter 10 Risk and opportunity

Chapter 11 Interested parties and stakeholders

Key messages from Part 3

Part 4 Context of the organization

Chapter 12 Understanding the organization and its context

Chapter 13 Understanding the needs and expectations of interested parties

Chapter 14 Scope of the quality management system

Chapter 15 Quality management system

Chapter 16 Processes needed for the QMS

Key messages from Part 4

Part 5 Leadership

Chapter 17 Leadership and commitment

Chapter 18 Customer focus

Chapter 19 Policy

Chapter 20 Organizational roles, responsibilities and authorities

Key messages from Part 5

Part 6 Planning

Chapter 21 Actions to address risks and opportunities

Chapter 22 Quality objectives and planning to achieve them

Chapter 23 Planning of changes

Key messages from Part 6

Part 7 Support

Chapter 24 People

Chapter 25 Infrastructure

Chapter 26 Environment for the operation of processes

Chapter 27 Monitoring and measuring resources

Chapter 28 Organizational knowledge

Chapter 29 Competence

Chapter 30 Awareness

Chapter 31 Communication

Chapter 32 Documented information

Key messages from Part 7

Part 8 Operation

Chapter 33 Operational planning and control

Chapter 34 Customer communication

Chapter 35 Requirements for products and services

Chapter 36 Review of requirements for products and services

Chapter 37 Design and development planning

Chapter 38 Design and development inputs

Chapter 39 Design and development controls

Chapter 40 Design and development outputs

Chapter 41 Design and development changes

Chapter 42 Control of externally provided processes, products and services

Chapter 43 Evaluation, selection and monitoring of external providers

Chapter 44 Information for external providers

Chapter 45 Control of production and service provision

Chapter 46 Identification and traceability

Chapter 47 Property belonging to external providers

Chapter 48 Preservation of process outputs

Chapter 49 Control of changes

Chapter 50 Release, delivery and post-delivery of products and services

Chapter 51 Control of nonconforming outputs

Key messages from Part 8

Part 9 Performance evaluation

Chapter 52 Monitoring, measurement, analysis and evaluation

Chapter 53 Customer satisfaction

Chapter 54 Analysis and evaluation

Chapter 55 Internal audit

Chapter 56 Management review

Key messages from Part 9

Part 10 Improvement

Chapter 57 Determining and selecting opportunities for improvement

Chapter 58 Nonconformity and corrective action

Chapter 59 Continual improvement of the QMS

Key messages from Part 10


A Common Acronyms

B Glossary of terms



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David Hoyle as a manager, consultant, author and mentor has been helping individuals and organizations across the world understand and apply ISO 9001 effectively since its inception in 1987. He has held senior positions in quality management with British Aerospace and Ferranti International and worked with such companies as General Motors, the UK Civil Aviation Authority and Bell Atlantic on their quality improvement programmes. Although neither a member of ISO nor BSI technical committees, he has been a member of the CQI for over 40 years and through his work with them built a network of like-minded professionals including members of ISO and BSI technical committees, which gave him privileged access to many reports, presentations and early drafts and thus gained an insight into the thinking behind ISO 9001:2015.


David Hoyle's latest work on this ISO 9000 Handbook once again "cracks the code", encrypted by the ISO TC 176 authors and offers, actionable, pragmatic advice for users and quality practitioners around the World on how to understand and effect the ISO 9000 family of documents. With so many competing publications on the subject, this 7th edition should be the essential, go-to handbook for quality professionals seeking to understand and benefit from an ISO 9001 modeled quality system.

Sidney Vianna, Management System Professional, DNV GL, USA. 

A must-have for anyone tasked with facilitating the creation and delivery of value to stakeholders, David Hoyle's staggeringly powerful latest edition of Quality Systems Handbook expertly and thoroughly demystifies the updated ISO 9000 Standards. An indispensable tool for managing quality and successful Certification.

 John Colebrook, Director, Enhanced Operating Systems Ltd, New Zealand.

A valuable resource that explores salient concepts arising from the ISO 9001:2015 standard in an unambiguous manner. David Hoyle using his inimitable step by step approach demonstrates the applicability of quality management standard to any organisational context.This book is definitely recommended reading for both academics and business leaders seeking to gain an in depth understanding of quality management systems.

Dr Lowellyne James, Lecturer in Quality Management, Robert Gordon University, IEMA Certificate in Sustainability Strategy Programme Leader, Scotland.

To be up-to-date with the latest in ISO 9000 Quality Systems (ISO9000:2015), this is the definitive guide to refer to. David Hoyle’s 7th edition stays true to its purpose of ensuring interpreting the Standard, comprehensible.

Christopher Seow, Visiting Lecturer "Six Sigma for Managers" Cass Business School, City, University of London, UK.

David Hoyle pulls no punches in this very comprehensive seventh edition of his ISO 9000 Handbook. Whether you are a scholar, business executive, quality manager, consultant or a Certification Body, this book is for you. He goes out of his way to change the misconception of what the ISO 9001:2015 standard is really all about. He meticulously explains that it is aimed at improved performance and not just a set of requirements for compliance. David convinces the reader that Quality should be managed as an integral part of every business.

Paul Harding, Managing Director, South African Quality Institute, South Africa.


Yet again David Hoyle has produced another excellent book that explains the new standard and its requirements in straightforward terms. It is the book we have all been waiting for that will help us implement the new Standard and will become the new bible for quality management Systems. If you follow the advice in Hoyle’s book you will not have any issues when the auditor arrives at your door. It is suitable for all people involved in the standard from company directors who need to know more about their responsibilities to experienced and busy Quality Managers who need to implement and inform others about the changes.

Rhian Newton, HSEQ Manager, Morgan Advanced Materials, UK.


The book does a great job of showing how a quality system built to the principles of ISO 9000 and conforming to the new ISO 9001:2015 requirements can be an integral part of leadership's strategic approach to running the business versus letting a quality management system operate in a silo.
The book explores and explains the ISO9001:2015 requirements in a way that is easy to follow yet at the same time deep and meaningful especially for those new concepts and requirements such as leadership, context of the organization and managing risk. This feels like a book I'll keep referring to for many years to come.

Richard Allan, Director, Quality Assurance, Kimberly-Clark Corporation, UK.