BS EN ISO 13488:2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
24-07-2003
English
15-03-2001
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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
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.
| Committee |
CH/210/1
|
| DevelopmentNote |
Supersedes BS EN 46002:1997 (02/2001)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 13488 : 2001 | Identical |
| I.S. EN ISO 13488:2000 | Identical |
| NEN EN ISO 13488 : 2000 | Identical |
| SN EN ISO 13488 : 2001 | Identical |
| EN ISO 13488 : 2000 | Identical |
| NBN EN ISO 13488 : 2001 | Identical |
| ISO 13488:1996 | Identical |
| UNE-EN ISO 13488:2001 | Identical |
| NS EN ISO 13488 : 1ED 2001 | Identical |
| DIN EN ISO 13488:2001-02 | Identical |
| ISO 8402:1994 | Quality management and quality assurance — Vocabulary |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
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