Revised ISO std vs ISO13485:2003 - Help Please!!!

#1
Hi all
We currently reference "ISO13485:2012 and ISO13485:2003" on our accreditation certificate, now when the new revised 13485 std comes into play our Notified Body have informed us they will no longer be assessing to the 2003 version of ISO13485.

Can anyone advise if firms outside of europe will still require accreditation to the 2003 std or whether they will globally recognise the new version of ISO13495. I did ask our NB but they weren't very helpful.
 
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SteveK

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#2
First off there is no such standards as ISO 13485:2012, only ISO 13485:2003. There is however EN ISO 13485:2012. Mind you we are still awaiting the publication ISO 13485:2015 (see other threads/posts on the subject especially from Marcelo ? plus the associated transition period).

Steve
 
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