7th Edition

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

By David Hoyle Copyright 2018
    892 Pages 101 B/W Illustrations
    by Routledge

    892 Pages 101 B/W Illustrations
    by Routledge

    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!


    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



    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.