I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
Hardcopy , PDF
29-08-2003
English
01-01-1997
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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.
| DevelopmentNote |
To be used in conjunction with I.S. EN ISO 9001. (02/2002)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| Standards | Relationship |
| EN 46001 : 1996 | Identical |
| DIN EN 46001:1996-09 | Identical |
| BS EN 46001:1997 | Identical |
| UNE-EN 46001:1996 | Identical |
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