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Superseded
View Superseded by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
|
| ProductNote |
Japanese PDF version unavailable from Intertek Inform.
|
| PublisherName |
Japanese Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 13485:2003 | Identical |
Reaffirmed 2015
A newer version of this standard is available.
View Current Edition
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.