ISO 9004:2000
Quality management systems — Guidelines for performance improvements
This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization.
This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.
This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.
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Quality management systems— Guidelines for performance improvements
Contents Page
Foreword
Introduction
0.1 General
0.2 Process approach
0.3 Relationship with ISO9001
0.4 Compatibility with other management systems
Quality management systems— Guidelines for performance improvements
1 Scope
2 Normative reference
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 requirements
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
6.1.1 Introduction
6.1.2 Issues to be considered
6.2 People
6.2.1 Involvement of people
6.2.2 Competence, awareness and training
6.2.2.1 Competence
6.2.2.2 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 realization
7.1 General guidance
7.1.1 Introduction
7.1.2 Issues to be considered
7.1.3 Managing processes
7.1.3.1 General
7.1.3.2 Process inputs, outputs and review
7.1.3.3 Product and process validation and changes
7.2 Processes related to interested parties
7.3 Design and development
7.3.1 General guidance
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 measuring and monitoring 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
8.2.1.1 General
8.2.1.2 Measurement and monitoring of customer satisfaction
8.2.1.3 Internal audit
8.2.1.4 Financial measures
8.2.1.5 Self-assessment
8.2.2 Measurement and monitoring of processes
8.2.3 Measurement and monitoring of product
8.2.4 Measurement and monitoring the satisfaction of interested parties
8.3 Control of nonconformity
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 organization
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
Process for continual improvement
Bibliography
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Quality management systems— Guidelines for performance improvements
Contents Page
Foreword
Introduction
0.1 General
0.2 Process approach
0.3 Relationship with ISO9001
0.4 Compatibility with other management systems
Quality management systems— Guidelines for performance improvements
1 Scope
2 Normative reference
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 requirements
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
6.1.1 Introduction
6.1.2 Issues to be considered
6.2 People
6.2.1 Involvement of people
6.2.2 Competence, awareness and training
6.2.2.1 Competence
6.2.2.2 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 realization
7.1 General guidance
7.1.1 Introduction
7.1.2 Issues to be considered
7.1.3 Managing processes
7.1.3.1 General
7.1.3.2 Process inputs, outputs and review
7.1.3.3 Product and process validation and changes
7.2 Processes related to interested parties
7.3 Design and development
7.3.1 General guidance
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 measuring and monitoring 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
8.2.1.1 General
8.2.1.2 Measurement and monitoring of customer satisfaction
8.2.1.3 Internal audit
8.2.1.4 Financial measures
8.2.1.5 Self-assessment
8.2.2 Measurement and monitoring of processes
8.2.3 Measurement and monitoring of product
8.2.4 Measurement and monitoring the satisfaction of interested parties
8.3 Control of nonconformity
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 organization
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
Process for continual improvement
Bibliography