ABSTRACT

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!

part 1|50 pages

Introduction

chapter 1|16 pages

Putting ISO 9001 in context

chapter 2|18 pages

Comparison between 2008 and 2015 editions

part 2|35 pages

Anatomy and use of the standards

chapter 4|8 pages

The ISO 9000 family of standards

chapter 5|23 pages

A practical guide to using these standards

part 3|84 pages

Terminology

chapter 6|11 pages

Quality

chapter 7|6 pages

Requirements

chapter 8|18 pages

Management system

chapter 9|22 pages

Process and the process approach

chapter 10|11 pages

Risk and opportunity

chapter 11|9 pages

Interested parties and stakeholders

part 4|83 pages

Context of the organization

chapter 14|11 pages

Scope of the quality management system

chapter 15|9 pages

Quality management system

chapter 16|32 pages

Processes needed for the QMS

part 5|67 pages

Leadership

chapter 17|26 pages

Leadership and commitment

chapter 18|6 pages

Customer focus

chapter 19|16 pages

Policy

part 6|52 pages

Planning

chapter 21|22 pages

Actions to address risks and opportunities

chapter 23|8 pages

Planning of changes

part 7|143 pages

Support

chapter 24|8 pages

People

chapter 25|9 pages

Infrastructure

chapter 26|13 pages

Environment for the operation of processes

chapter 27|19 pages

Monitoring and measuring resources

chapter 28|11 pages

Organizational knowledge

chapter 29|18 pages

Competence

chapter 30|7 pages

Awareness

chapter 31|14 pages

Communication

chapter 32|36 pages

Documented information

part 8|214 pages

Operation

chapter 33|16 pages

Operational planning and control

chapter 34|14 pages

Customer communication

chapter 35|11 pages

Requirements for products and services

chapter 37|22 pages

Design and development planning

chapter 38|11 pages

Design and development inputs

chapter 39|13 pages

Design and development controls

chapter 40|9 pages

Design and development outputs

chapter 41|7 pages

Design and development changes

chapter 44|10 pages

Information for external providers

chapter 45|15 pages

Control of production and service provision

chapter 46|6 pages

Identification and traceability

chapter 47|6 pages

Property belonging to external providers

chapter 48|6 pages

Preservation of process outputs

chapter 49|4 pages

Control of changes

chapter 51|11 pages

Control of nonconforming outputs

part 9|73 pages

Performance evaluation

chapter 53|9 pages

Customer satisfaction

chapter 54|15 pages

Analysis and evaluation

chapter 55|20 pages

Internal audit

chapter 56|13 pages

Management review

part 10|41 pages

Improvement

chapter 58|21 pages

Nonconformity and corrective action

chapter 59|7 pages

Continual improvement of the QMS