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ISO 13485:2015 Pre-Release News and Discussion - Page 2


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iso 13485 - medical device qms, revisions to a document or standard, iso 13485:2016
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  Post Number #9  
Old 16th April 2011, 10:17 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: News on the ISO 13485 revision

Quote:
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.
The problem is really more weird, and, as i've said somewhere else before, even the EU is not really sure of their own arguments (I was with the guy responsible for the formal Eu answer to this problem and he even he wasn't aware what was really happening :-))

One example - in New Approach directives, directives have essential (less detailed) requirements, and harmonized standards details that essentials requirements and therefore gives 'presumption of conformity' with the essential requirements they are linked with (annex zx). However, this presumption of conformity is only related to the essential requirements which are given in annex I of the directives. Quality system requirements are not in Annex I, they are only required in the "route" annexes (particularly the annex II route - full quality assurance). So, one of the problems is that ISO 13485 cannot really give presumption of conformity.

Quote:
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.
Yes, Kim Trautman is a WG 1 member and represents the FDA. From the standpoint of the standard, she didn't seem to have any problems (she mentioned the VARSP program but only to remember that she would prefer the standard to stick to requirements which were already on the regulations) but nothing regarding the EU. As i said, the focus of the discussion obviously was the standard, not the regulations that use them, because it was deemed that a lot of the comments were really problems of the regulations, not the standard.

Update: Just to make things clear here, i didn't imply i know Kim's or FDA's position, what i said is only what I felt during the meeting.

Last edited by Marcelo Antunes; 17th April 2011 at 06:41 PM.
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  Post Number #10  
Old 25th October 2011, 09:43 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: News on the ISO 13485 revision

Another update on the ISO 13485 revision - ISO TC 210 WG 1 met last week and reviewed some issues, including the results of the user survey. The survey had a lot os responses, however one major problem is that almost 90 % of the respondents wer from the US or Europe. We are going to reopen the survey to see if we can find more comments from other parts of the world.

The 14 original topics for revision (not 17 as i mentioned before) were expanded to 24 due to the answers from the survey.

We have already separated 24 groups to deal with each topic, and everyone can now begin working on specific topics.

Next meeting will be in March 2012.
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  Post Number #11  
Old 25th October 2011, 10:17 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
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Re: News on the ISO 13485 revision

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In Reply to Parent Post by mmantunes View Post

The survey had a lot os responses, however one major problem is that almost 90 % of the respondents wer from the US or Europe. We are going to reopen the survey to see if we can find more comments from other parts of the world.
Realizing that, based on the latest ISO Survey, Europe and North America represent about 75% of the ISO 13485 certificates in the World, that is expected.

I have no idea how the TC 210 operates, but some other TC's go through the hassle of surveys just to totally disregard the feedback from the users in the end. After all what do the users of standards know?
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  Post Number #12  
Old 25th October 2011, 10:26 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: News on the ISO 13485 revision

Quote:
Realizing that, based on the latest ISO Survey, Europe and North America represent about 75% of the ISO 13485 certificates in the World, that is expected.
Yeah, we did make this link, however WG 1 would still want to hear more perspectives.

Quote:
I have no idea how the TC 210 operates, but some other TC's go through the hassle of surveys just to totally disregard the feedback from the users in the end. After all what do the users of standards know?
I've also seen this kind of behavior from some other TCs and was pleased when I discovered that ISO TC 210 WG 1 is really worried about the user input.

One member has already performed the herculean task of separating all comments in their respectives topics, and the small groups working in each topic will revise all comments related to that topic. Sure a lot of comments will be deleted because they add no value or something like that, but int the brief overview we performed on one of the topics, we did find a lot of interesting comments.

So, i'm pretty sure that these will at least be taken into account when drafting the revised standard.

But obviously we cannot please everyone :-P
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  Post Number #13  
Old 17th January 2012, 12:20 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,024
Re: News on the ISO 13485 revision

Quote:
I have no idea how the TC 210 operates, but some other TC's go through the hassle of surveys just to totally disregard the feedback from the users in the end. After all what do the users of standards know?
One of the problems (I´ve been revising some of the comments in the last few days) is that a great part of the comments are not related to the standard, but are related to the implementation of the standard. Example - comments related to how auditors perform auditing of ISO 13485.

Another type (a lot) are like - included FDA or EU requirements - which cannot be included because ISO 13485 does not include regional/national regulations due to the objective of being an harmonized standard worldwide - also ,ISO 13485 is already aligned with those.

Anyway, a lot of the comments are interesting and will require action.

Last edited by Marcelo Antunes; 17th January 2012 at 12:26 AM.
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  Post Number #14  
Old 23rd January 2012, 09:33 PM
Roland Cooke

 
 
Total Posts: 613
Re: News on the ISO 13485 revision - 2011 - 2012

Is the intent to bring out a revised version of ISO 14969 at around the same time, or is that a completely unrelated task?
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  Post Number #15  
Old 23rd January 2012, 09:37 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: News on the ISO 13485 revision - 2011 - 2012

Quote:
Is the intent to bring out a revised version of ISO 14969 at around the same time, or is that a completely unrelated task?
It´s a complete unrelated task (including formally, because there will be a need to issue a NWIP).

However, the group was tasked with identifying possible revisions to 14969. And come comments even mentioned the need to include a streamlined version of 14969 in 13485 (which in fact is not a crazy idea - it would surely help promoting in a better way the guidance).
  Post Number #16  
Old 25th January 2012, 12:52 PM
Roland Cooke

 
 
Total Posts: 613
Re: News on the ISO 13485 revision - 2011 - 2012

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

some comments even mentioned the need to include a streamlined version of 14969 in 13485 (which in fact is not a crazy idea - it would surely help promoting in a better way the guidance).
Interesting suggestion, so that would be in the form of some kind of non-binding guidance appendix?
Thanks to Roland Cooke for your informative Post and/or Attachment!
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