Foreword
Introduction
0.1 General
0.2 Process approach
0.3 Relationship with EN ISO 9001
0.4 Compatibility with other management systems
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
4.1 Managing systems and processes
4.2 Documentation
4.3 Use of quality management principles
5 Management responsibility
5.1 General guidance
5.1.1 Introduction
5.1.2 Issues to be considered
5.2 Needs and expectations of interested parties
5.2.1 General
5.2.2 Needs and expectations
5.2.3 Statutory and regulatory plans
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6 Resource management
6.1 General guidance
6.1.2 Issues to be considered
6.2 Human resources
6.2.3 Involvement of people
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
6.5 Information
6.6 Suppliers and partnerships
6.7 Natural resources
6.8 Financial resources
7 Product realisation
7.1 General guidance
7.1.1 Introduction
7.1.2 Issues to be considered
7.1.3. Managing processes
7.2 Process related to interested parties
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development input and output
7.3.3 Design and development review
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Supplier control process
7.5 Production and service operations
7.5.1 Operation and realization
7.5.2 Identification and traceability
7.5.3 Customer property
7.5.4 Preservation of product
7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
8.1 General guidance
8.1.1 Introduction
8.1.2 Issues to be considered
8.2 Measurement and monitoring
8.2.1 Measurement and monitoring of system
performance
8.2.2 Measurement and monitoring of processes
8.2.3 Measurement and monitoring of products
8.2.4 Measurement and monitoring the
satisfaction of interested parties
8.3 Control of non-conformity
8.3.1 General
8.3.2 Nonconformity review and disposition
8.4 Analysis of data
8.5 Improvement
8.5.1 General
8.5.2 Corrective action
8.5.3 Loss prevention
8.5.4 Continual improvement of the organisation
Annex A (informative) Guidelines for self-assessment
A.1 Introduction
A.2 Performance maturity levels
A.3 Self-assessment questions
A.4 Documentation of self-assessment
results
A.5 Linking potential benefits of ISO 9004
to self-assessment
Annex B (informative) Process for continual improvement
Bibliography