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