QMS language

Barbora

Starting to get Involved
Hello,

In December, during a surveillance audit for MDD certified medical devices, we were notified that our QMS would need to be translated into English for the next (also surveillance) audit. May I ask if this information is true and where it is taken from?

Note: The certification body that certifies our QMS (ISO 13485) is different than the company that audited us in December.

Thank you!
 

Philip B

Quite Involved in Discussions
Who were the people who audited you in December, a consultant or similar? The language in which certification audits need to be conducted is normally specified by your certification body in their contract. If they say it has to be English, then English it has to be. If it is someone else requesting this then it's up to you...
 

Barbora

Starting to get Involved
Thank you for your reply. It was a different certification body... So we will translate the whole QMS into English:)
 
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