09/30202002 DC : 0

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
   3.1 product realization
4 Quality management system
   4.1 General requirements
       4.1.1 Outsourced processes
   4.2 Documentation requirements
       4.2.1 General
       4.2.2 Quality manual
       4.2.3 Control of documents
       4.2.4 Control of records
5 Management responsibility
   5.1 Management commitment
   5.2 Customer focus
   5.3 Quality policy
   5.4 Planning
       5.4.1 Quality objectives
       5.4.2 Quality management system 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 Provision of resources
   6.2 Human resources
       6.2.1 General
       6.2.2 Competence, training and awareness
   6.3 Infrastructure
   6.4 Work environment
7 Product realization
   7.1 Planning of product realization
       7.1.1 Product and process validation
       7.1.2 Control of changes
   7.2 Customer-related processes
       7.2.1 Determination of requirements related to the
             product
       7.2.2 Review of requirements related to the product
       7.2.3 Customer communication
   7.3 Design and development
       7.3.1 Design and development inputs
       7.3.2 Design and development inputs
       7.3.3 Design and development outputs
       7.3.4 Design and development review
       7.3.5 Design and development verification
       7.3.6 Design and development validation
       7.3.7 Control of design and development changes
   7.4 Purchasing
       7.4.1 Purchasing process
       7.4.2 Purchasing information
       7.4.3 Verification of purchased product
   7.5 Production and service provision
       7.5.1 Control of production and service provision
       7.5.2 Validation of processes for production and service
             provision
       7.5.3 Identification and traceability
       7.5.4 Customer property
       7.5.5 Preservation of product
   7.6 Control of monitoring and measuring equipment
       7.6.1 Measurement system analysis
       7.6.2 Calibration/verification records
       7.6.3 Laboratory/sampling requirements
8 Measurement, analysis and improvement
   8.1 General
   8.2 Monitoring and measurement
       8.2.1 Customer satisfaction
       8.2.2 Internal audit
       8.2.3 Monitoring and measurement of processes
       8.2.4 Monitoring and measurement of product
   8.3 Control of nonconforming product
       8.3.1 Control of reworked product
       8.3.2 Customer information
   8.4 Analysis of data
   8.5 Improvement
       8.5.1 Continual improvement
       8.5.2 Corrective action
       8.5.3 Preventive action
9 Bibliography

BS EN 15358