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EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday

S

Shamann2

#1
We just had an unannounced MDD audit yesterday. The auditor reviewed the last Management Review, which mentioned that ISO 13485:2016 had been published. He commented that we should have called out EN ISO 13485:2016. Can someone tell me what the differences are between the two versions? I know that I was required to write a commentary (for the same notified body) on the differences between the two earlier versions. I'd hate for this small company to have to purchase yet another copy of 13485 if there are no differences. But I can't seem to find anything on the EN version, except for purchasing information. Can anyone comment?
 
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mihzago

Trusted Information Resource
#2
The normative section of both versions of the standards are identical.
The only difference is that EN ISO 13485:2016 contains informative Z annexes that describe the relationship between the Standard and the MDD, and it basically states that the Standard does not provide presumption of conformity with all aspects of whatever the Annex you use for claiming compliance.


Some national standards bodies issue their own version of the standards or the annexes by themselves that you can get for lower price or even free if you search around (not for commercial use though).
 

Ronen E

Problem Solver
Staff member
Moderator
#3
We just had an unannounced MDD audit yesterday. The auditor reviewed the last Management Review, which mentioned that ISO 13485:2016 had been published. He commented that we should have called out EN ISO 13485:2016. Can someone tell me what the differences are between the two versions? I know that I was required to write a commentary (for the same notified body) on the differences between the two earlier versions. I'd hate for this small company to have to purchase yet another copy of 13485 if there are no differences. But I can't seem to find anything on the EN version, except for purchasing information. Can anyone comment?
Hi,

First off, according to the official publication EN ISO 13485:2016 is not yet harmonized. So the comment is not warranted in my opinion, unless it was by way of a friendly suggestion.

It is correct that in issuing EN ISO 13485:2016 CEN has endorsed the ISO 13485:2016 text without any modification. The added value in using the EN version is the Z annexes. On the Danish Standards website you can browse a free preview that contains the 2016 version Z annexes in full.

Cheers,
Ronen.
 
Last edited:
S

Shamann2

#4
Thanks for both responses. Thank you for the link to the preview. Also, the purchase price there is significantly lower than the BS version.
 
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