BS EN ISO 13488:2001

Contents
1. Scope
2. Normative references
3. 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 nonconforming product
    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

Specifies in conjunction with ISO 9002, the quality system requirements for the production, installation and servicing of medical devices when relevant. It applies when there is a need to assess a medical device supplier's quality system.