I.S. EN ISO 13488:2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 9002
Hardcopy , PDF
27-08-2003
English
01-01-2000
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.
Dates of withdrawal of national standards are available from NSAI.
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Contents
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 nonconforming product
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
Describes, in conjunction with ISO 9002, the quality system requirements for the production and, when relevant, installation and servicing of medical devices.
| DevelopmentNote |
Supersedes I.S. EN 46002. (11/2016)
|
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 13488 : 2001 | Identical |
| SN EN ISO 13488 : 2001 | Identical |
| EN ISO 13488 : 2000 | Identical |
| NBN EN ISO 13488 : 2001 | Identical |
| ISO 13488:1996 | Identical |
| NS EN ISO 13488 : 1ED 2001 | Identical |
| UNE-EN ISO 13488:2001 | Identical |
| NEN EN ISO 13488 : 2000 | Identical |
| BS EN ISO 13488:2001 | Identical |
| DIN EN ISO 13488:2001-02 | Identical |
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