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ISO 9000 Quality Systems Handbook-updated for the ISO 9001


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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 Appendices A Common Acronyms B Glossary of terms Index

About the Author

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.

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