Elsmar Cove Quality DiscussionsEN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterdayThe Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday
UL - Underwriters Laboratories - Health Sciences
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

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


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




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

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


Some Related Topic Tags
differences (general), iso 13485 - medical device qms, iso 13485:2016
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 13th January 2017, 02:36 PM
Shamann2

 
 
Total Posts: 16
Please Help! EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday

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?

Sponsored Links
  Post Number #2  
Old 13th January 2017, 04:24 PM
mihzago

 
 
Total Posts: 176
Re: EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday

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).
Thank You to mihzago for your informative Post and/or Attachment!
  Post Number #3  
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!
  Post Number #4  
Old 17th January 2017, 01:14 PM
Shamann2

 
 
Total Posts: 16
Re: EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday

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

Last edited by Shamann2; 17th January 2017 at 01:21 PM.
  Post Number #5  
Old 2nd February 2017, 12:13 AM
Sam Lazzara's Avatar
Sam Lazzara

 
 
Total Posts: 258
Re: EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday

Only 19 Euros here for single-user license
https://www.evs.ee/products/evs-en-iso-13485-2016
Thanks to Sam Lazzara for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Audit Checklist for ISO 13485:2016 al40 ISO 13485:2016 - Medical Device Quality Management Systems 10 25th October 2017 08:09 PM
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison al40 ISO 13485:2016 - Medical Device Quality Management Systems 3 27th January 2017 04:22 PM
Migration (Transition) to ISO 13485:2016 from ISO 13485:2003 sriramsl ISO 13485:2016 - Medical Device Quality Management Systems 1 27th October 2016 02:46 PM
TGA Transition to ISO 13485:2016 Marcelo Antunes ISO 13485:2016 - Medical Device Quality Management Systems 0 8th August 2016 09:16 PM
Do I need to certify to ISO 13485:2016? mscottf ISO 13485:2016 - Medical Device Quality Management Systems 5 19th May 2016 08:40 AM



The time now is 09:59 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"