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Old 13th January 2017, 08:56 PM
Ronen E

Total Posts: 3,736
Re: EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday

In Reply to Parent Post by Shamann2 View Post

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?

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.


Last edited by Ronen E; 17th January 2017 at 06:42 PM.
Thank You to Ronen E for your informative Post and/or Attachment!

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