EN 46003 : 1999

Foreword
      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 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
Annex ZA (informative) Clauses of this European Standard addressing
                       essential requirements or other provisions of
                       EU Directives

Defines, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements.