DIN EN 50103:1997-04
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
11-01-2007
01-12-2013
Foreword
Introduction
1. Scope
2. Normative references
3. Terminology and definitions
3.1 Terminology
3.2 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 non-conforming 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
Annexes
A. (informative) Terminology - Index of terms
B. (informative) Bibliography
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