The Cove Business Standards Discussion Forums
Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Single Post View
 
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

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

Sponsored Links
 

The time now is 08:03 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"