NS EN ISO 13488 : 1ED 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 9002
15-08-2003
12-01-2013
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
Specifies in conjunction with ISO 9002, the quality system requirements for the production, installation and servicing of medical devices when relevant. It applies when there is a need to assess a medical device supplier's quality system.
| DocumentType |
Standard
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Superseded
|
| Standards | Relationship |
| BS EN ISO 13488:2001 | Identical |
| UNE-EN ISO 13488:2001 | Identical |
| ISO 13488:1996 | Identical |
| EN ISO 13488 : 2000 | Identical |
| DIN EN ISO 13488:2001-02 | Identical |
| I.S. EN ISO 13488:2000 | Identical |
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