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JIS Q 13485:2005

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical devices - Quality management systems - Requirements for regulatory purposes
Available format(s)

Hardcopy , PDF

Superseded date

11-12-2020

Language(s)

English, Japanese

Published date

09-01-2006

Publisher

Japanese Standards Association

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This Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

DocumentType
Standard
Pages
15
PublisherName
Japanese Standards Association
Status
Superseded
SupersededBy
Supersedes

Reaffirmed 2015

JIS Q 9000:2006 Quality management systems - Fundamentals and vocabulary

JIS TR Q14969:2007 Medical Devices - Quality Management System - Guidance On The Application Of Jis Q 13485:2005
JIS T 7329:2008 Washer sterilizers for medical use

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Hardcopy - English
PDF - English
Hardcopy - Japanese
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