ISO 9000 Quality Systems Handbook-updated for the ISO 9001: 2015 standard (7^th Ed.) Increasing the Quality of an Organization’s Outputs

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!

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

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.