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