ISO 14969:1999

1 Scope
2 Normative references
3 Terms and definitions
4 Quality system requirements
    4.1 Management responsibility
    4.2 Quality system
    4.3 Contract review
    4.4 Design control
    4.5 Document and data control
    4.6 Purchasing
    4.7 Control of customer-supplied product
    4.8 Product identification and traceability
    4.9 Process control
    4.10 Inspection and testing
    4.11 Control of inspection, measuring and test
          equipment
    4.12 Inspection and test status
    4.13 Control of nonconforming product
    4.14 Corrective and preventive action
    4.15 Handling, storage, packaging, preservation
          and delivery
    4.16 Control of quality records
    4.17 Internal quality audits
    4.18 Training
    4.19 Servicing
    4.20 Statistical techniques
Annex A (informative) Comparison of International
Standards on quality system requirements for medical devices
Annex B (informative) Terms used in certain regulatory
administrations to describe documents referenced in this
International Standard
Bibliography

Gives guidance for the application of the requirements for quality management systems contained in ISO 13485.