Preface
Foreword
Introduction
0.1 General
0.2 Organizational goals
0.3 Meeting company/customer needs
0.4 Risks, costs and benefits
0.5 Conclusions
1 Scope
2 Normative reference
3 Definitions
4 Management responsibility
4.1 General
4.2 Quality policy
4.3 Quality objectives
4.4 Quality system
5 Quality system principles
5.1 Quality system elements
5.2 Structure of the quality system
5.3 Documentation of the system
5.4 Auditing the quality system
5.5 Review and evaluation of the quality system
6 Economics-Quality-related cost considerations
6.1 General
6.2 Selecting appropriate elements
6.3 Types of quality-related costs
6.4 Management visibility
7 Quality in marketing
7.1 Marketing requirements
7.2 Product brief
7.3 Customer feedback information
7.4 Joint development
8 Quality in specification and design/development
8.1 Contribution of specification and design to
quality
8.2 Planning and objectives of design/development
(defining the project)
8.3 Product testing and measurement
8.4 Process and product design qualification and
validation
8.5 Review in design/development
8.6 Approval for commercial production
8.7 Market readiness review
8.8 Change control of product and process
specification
8.9 Requalification of product and process
specifications
9 Quality in procurement
9.1 General
9.2 Requirements for specifications, drawings and
purchase orders
9.3 Selection of qualified suppliers
9.4 Agreement on quality assurance
9.5 Agreement on verification methods
9.6 Provisions for settlement of quality disputes
9.7 Receiving inspection planning and controls
9.8 Receiving quality records
10 Quality in production
10.1 Planning for controlled production
10.2 Process capability
10.3 Supplies, utilities and environments
11 Control of production
11.1 General
11.2 Material control and traceability
11.3 Equipment control and maintenance
11.4 Special processes
11.5 Documentation
11.6 Process change control
11.7 Control of verification status
11.8 Control of nonconforming materials
12 Product verification
12.1 Incoming materials
12.2 In-process monitoring and control
12.3 Completed-product verification
13 Control of measuring and test equipment
13.1 Measurement control
13.2 Elements of control
13.3 Supplier measurement controls
13.4 Corrective action
13.5 Outside testing
14 Nonconformity
14.1 General
14.2 Identification
14.3 Segregation
14.4 Review
14.5 Disposition
14.6 Documentation
14.7 Prevention of recurrence
15 Corrective action
15.1 General
15.2 Assignment of responsibility
15.3 Evaluation of importance
15.4 Investigation of possible causes
15.5 Analysis of problem
15.6 Preventive action
15.7 Process controls
15.8 Disposition of nonconforming processed
materials
15.9 Permanent changes
16 Handling and post-production functions
16.1 Handling, storage, identification, packaging,
transportation and distribution
16.2 After-sales servicing
16.3 Marketing reporting and product supervision
17 Quality documentation and records
17.1 General
17.2 Quality documentation
17.3 Quality records
18 Personnel
18.1 Training
18.2 Qualification
18.3 Motivation
19 Product safety and liability
20 Use of statistical methods
20.1 Applications
20.2 Statistical techniques
Annex A Bibliography