JIS Q 13488:1998

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

This Standard specifies, in conjunction with JIS Z 9902, the quality system requirements for the production and, when relevant, installation and servicing of medical devices. This Standard, in conjunction with JIS Z 9902, is applicable when there is a need to assess a medical device supplier\'s quality system. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this Standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.

1998 [25/03/1998]