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ISO 13485:2015 Pre-Release News and Discussion


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iso 13485 - medical device qms, revisions to a document or standard, iso 13485:2016
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  Post Number #1  
Old 14th April 2011, 06:42 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Look! ISO 13485:2015 Pre-Release News and Discussion

Hello all

Just some quick news, ISO 13485 is going to be revised, a decision was made on the meeting of ISO TC 210 WG 1 this week. There's at least some 17 topics which are going to be revised or enhanced. A new work proposal will be circulated within the next month or so, along with a user survey on other possible changes.

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  Post Number #2  
Old 15th April 2011, 12:22 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
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Re: News on the ISO 13485 revision

This seems to be a "freshly baked" news as I didnt read anywhere

Thanks for informing, Marcelo !
Thank You to Ajit Basrur for your informative Post and/or Attachment!
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  Post Number #3  
Old 15th April 2011, 12:27 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: News on the ISO 13485 revision

Ajit

Sure it is, the meeting ended yesterday, I only know because i was there :-)

Anyway, i just made this quick comment so our Cove members could begin to collect their comments on possible modifications. Maybe we could open a thread on this so people can freely comment. I'm sure the members of the Cove could greatly help giving their views of problems and solutions.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #4  
Old 15th April 2011, 01:15 AM
manju.ado

 
 
Total Posts: 17
Re: News on the ISO 13485 revision

Thank you Marcelo for the news.

Its good idea to have a thread, gives right platform to discuss and provide comments.

Thanks again.

Regards,

Manju
  Post Number #5  
Old 15th April 2011, 02:21 PM
GPjeri

 
 
Total Posts: 52
Re: News on the ISO 13485 revision

Wow, THANKS !!!! Just listened to a webinar the other day where this was mentioned but on a very high level also talked about de-harmonizing some standards and potentially revising ISO 14971.
  Post Number #6  
Old 15th April 2011, 03:36 PM
MIREGMGR

 
 
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Re: News on the ISO 13485 revision

Does this encompass Sweden's issues with ISO 13485 in regard to its compability with the various Directives?
  Post Number #7  
Old 15th April 2011, 07:41 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: News on the ISO 13485 revision

Quote:
Does this encompass Sweden's issues with ISO 13485 in regard to its compability with the various Directives?
Yes, their issues were discussed and some where taken into account, but others deemed a problem of the directives and not of the standard (and some too euro-centric too, also related to the directives).

The person responsible for the Sweden issues is a member of TC 210 and was there, so there seems to be, in principle, a solved issue regarding the standard (but there might still be problem in the EU).
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #8  
Old 16th April 2011, 03:11 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: News on the ISO 13485 revision

I've been under the impression that the argument being made by some EU parties was that the Directives are law while the Standards (ISO 13485, ISO 14971, etc.) are adopted documents, therefore both practically and theoretically the Standards would have to change to conform to the Directives.

It's an odd issue to arise, given ISO 13485's history.

Was US FDA represented in the discussions? I'm very curious as to whether this will affect US FDA's movement toward VARSP acceptance of NB-certified ISO 13485 conformance in place of QSIT1 inspection exposure.
Thank You to MIREGMGR for your informative Post and/or Attachment!
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