JIS Q 13488:1998
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Quality systems - Medical devices - Particular requirements for the application of JIS Z 9902
Hardcopy , PDF
25-06-2006
English, Japanese
25-03-1998
Introduction1 Scope2 Normative references3 Definitions4 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
Applies when there is a need to assess a medical device supplier's quality system.
| DocumentType |
Standard
|
| Pages |
13
|
| ProductNote |
To be read in conjunction with JIS Z9902. (10/2002)
|
| PublisherName |
Japanese Standards Association
|
| Status |
Withdrawn
|
| SupersededBy |
1998 [25/03/1998]
| JIS Z 9902:1998 | Quality systems - Model for quality assurance in production, installation and servicing |
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