UNI EN 724 : 1996

Committees responsible
National foreword
Foreword
Introduction
1. Scope
2. Normative references
3. Definitions
4. Guidance on quality system requirements
4.1 Management responsibility
4.2 Quality system
4.3 Contract review
4.4 Design control
4.5 Document control
4.6 Purchasing
4.7 Purchaser supplied product
4.8 Product identification and traceability
4.9 Process control
4.10 Inspection and testing
4.11 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 and delivery
4.16 Quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
Annex A (informative) Guidance on elements of quality
     systems relevant to sterile product manufacture
Annex B (informative) Features of job descriptions
     of key individuals
Annex C (informative) Bibliography

Gives advice on the establishment and maintenance of the quality systems specified in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacture of non-active medical devices. Coverage includes: management responsibility, contract review, design control, purchasing, process control, quality records, internal quality audits, corrective action, and control of nonconforming product. Also gives detailed definitions and annexes.