T
Tiffany
Hi,
When is the revision of ISO13485 will be revised? Whats the status?
Tiffany
When is the revision of ISO13485 will be revised? Whats the status?
Tiffany
Hi,
When is the revision of ISO13485 will be revised? Whats the status?
Tiffany
Hi Everybody,
We just passed our first surveillance audit on Wednesday for ISO 13485. During the audit the auditor did ask us about the version of 13485 we have and noted that we did in fact not have the newest one which we believed was 13485:2003-11. In fact she showed us that the standard was updated to 13485:2007-10 (She showed us the German version of the standard).
Best Regards
Andreas
Document: Norm
Ausgabedatum: Issue date: 2007-10
Titel (deutsch): Title (German): Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003); Deutsche Fassung
EN ISO 13485:2003+AC:2007 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003 + AC: 2007
Titel (englisch): Title (English):
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007
Originalsprachen: Original languages: Deutsch German
Preis: Price: EUR 117,00 $ 117.00
So, do we have to get the latest ISO 13485 : 2007 version. Is itthe latest?
So, do we have to get the latest ISO 13485 : 2007 version. Is itthe latest?