JIS Q 13485:2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical devices - Quality management systems - Requirements for regulatory purposes
Hardcopy , PDF
12-11-2020
English, Japanese
01-09-2006
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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Superseded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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