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ISO 9000 Quality Systems Handbook 5th Edition
Since publication of the fourth edition in 2000, David Hoyle has collected the experiences of organizations, quality managers and auditors who have actually worked with the present version of the ISO 9000 standard, and these are now presented in this new edition of this the leading quality management systems guide.
Preface to the 5th edition
Chapter
1
Basic concepts
Introduction
Principles or prescription
Needs, requirements and expectations
Quality
The interested parties or stakeholders
The characteristics of quality
Achieving sustaining and improving quality
Summary
Basic concepts - Food for thought
Chapter 2
Perceptions of ISO 9000 and its derivatives
Introduction
How we think about certification
How ISO 9000 made us think about quality
How we think about reviews, inspections and audits
Is ISO 9000:2000 any different?
Misconceptions about the ISO 9000 family
Summary
Perceptions of ISO 9000 and its derivatives - Food for thought
Chapter 3
Role, origins and application of ISO 9000
Why was ISO 9000 created?
What does ISO 9000 apply to?
Why would we need to use these standards?
Origin of ISO 9000
Using the ISO 9000 family of standards
Exclusions
Certification to ISO 90001:2000
ISO 9000 derivatives
Comparisons with other models
Summary
Role, origins and application - Food for thought
Chapter 4
Quality management system
Summary of requirements
Establishing a quality management system
Identifying processes (4.1a) 1
Sequence and interaction of processes (4.1b)
Criteria and methods for effective operation and control (4.1c)
Documenting a quality management system (4.1, 4.2.1)
Documented procedures (4.2.1c)
Documents that ensure effective planning, operation and control of processes
(4.2.1d)
Implementing a quality management system (4.1)
Managing processes (4.1)
Ensuring information availability (4.1d)
Ensuring the availability of resources (4.1d)
Measuring, monitoring and analysing processes (4.1e)
Maintaining a quality management system (4.1)
Continual improvement in the quality management system and its processes
(4.1 and 4.1f)
Outsourcing (4.1)
Preparing the quality manual (4.2.1b)
Control of documents (4.2.3)
Control of records (4.2.1e and 4.2.4)
Summary
Quality Management System Requirements Checklist Quality Management System - Food for Thought Chapter 5 Management responsibility
Summary of requirements
Management commitment (5.1)
Customer focus (5.2)
Quality Policy (5.3)
Quality objectives (5.4.1)
Quality management system planning (5.4.2)
Responsibility and authority (5.5.1)
Management Representative (5.5.2)
Internal communication (5.5.3)
Management Review (5.6)
Summary
Management Responsibility Requirement Checklist
Management Responsibility - Food for thought
Chapter 6 Resource management
Summary of requirements
Determining resources (6.2.1)
Providing resources (6.2.1)
Competence of personnel (6.2.1)
Training awareness and competence (6.2.2) Infrastructure (6.3)
Work environment (6.4)
Summary
Resource management requirements summary
Resource management - Food for thought
Chapter 7
Product realization
Summary of requirements
Planning product realization processes (7.1)
Customer-related processes (7.2)
Design and development (7.3)
Purchasing (7.4)
Production and service provision (7.5)
Control of measuring and monitoring devices (7.6)
Summary
Product realization requirements checklist
Product realization - Food for thought
Chapter 8
Measurement, analysis and improvement
Summary of requirements
Monitoring, measurement, analysis and improvement processes (8.1)
Customer satisfaction (8.2.1)
Internal audit (8.2.2)
Measurement and monitoring of processes (8.2.3)
Measurement and monitoring of product (8.2.4)
Control of nonconforming product (8.3)
Analysis of data (8.4)
Improvement (8.5)
Summary
Measurement, analysis and improvement requirements checklist
Measurement, analysis and improvement - food for thought
Appendix A ~ Glossary
Appendix B ~ Related web sites
Appendix C - Bibliography
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