EN 46001 : 1996

Foreword
0 Introduction
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 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) - Bibliography

Specifies the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.