BS EN 46003:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003
Hardcopy , PDF
English
15-10-1999
31-01-2008
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.
| Committee |
CH/210/1
|
| DevelopmentNote |
Supersedes 96/561178 DC. (09/2005)
|
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN 46003 : 1999 | Identical |
| DIN EN 46003:1999-10 | Identical |
| NS EN 46003 : 1ED 1999 | Identical |
| NBN EN 46003 : 1ED 2000 | Identical |
| NF EN 46003 : 1999 | Identical |
| I.S. EN 46003:2000 | Identical |
| EN 46003 : 1999 | Identical |
| UNE-EN 46003:2000 | Identical |
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