JIS Q 13485:2005
Superseded
View Superseded by
Medical devices -- Quality management systems -- Requirements for regulatory purposes
English
10-01-2005
11-12-2020
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Superseded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 |
| Standards | Relationship |
| ISO 13485:2003 | Identical |
Reaffirmed 2015
| JIS Q 9000:2006 | Quality management systems -- Fundamentals and vocabulary |
| TR Q 14969:2007 | 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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