BS EN 46001:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Specification for application of EN ISO 9001 to the manufacture of medical devices
Hardcopy , PDF
English
15-02-1997
15-03-2001
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.
| Committee |
CH/210/1
|
| DevelopmentNote |
Supersedes 90/56565 DC. To be read in conjunction with EN ISO 9001. (07/2003)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN 46001:1996-09 | Identical |
| NBN EN 46001 : 1996 | Identical |
| NEN EN 46001 : 1996 | Identical |
| EN 46001 : 1996 | Identical |
| I.S. EN 46001:1997 | Identical |
| NF EN 46001 : 1996 | Identical |
| UNE-EN 46001:1996 | Identical |
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