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JIS Q 13488:1998

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Quality systems - Medical devices - Particular requirements for the application of JIS Z 9902
Available format(s)

Hardcopy , PDF

Withdrawn date

06-25-2006

Language(s)

English, Japanese

Published date

03-25-1998

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Withdrawn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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