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iso 13485 - medical device qms, revisions to a document or standard, iso 13485:2016
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  Post Number #41  
Old 21st June 2012, 08:00 AM
Asiah

 
 
Total Posts: 7
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

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

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.
Hi! Thanks for sharing.

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  Post Number #42  
Old 18th October 2012, 08:17 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,961
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Heya all

ISO TC 210 WG 1 - Application of quality systems to medical devices met last week in Santa Rosa, CA, to discuss the revision of ISO 13485.

There were a lot of comments for the Working Draft (all internal to the WG because WDs are not circulated outside) and we split into 5 separate groups to deal with the comments.

There was some interesting discussions and decisions (I was particularly interested in software this time because I had to report back to JWG 3) but in general it seems that people came to an agreement in each group.

But it's interesting to note, due to the volume of changes, this revision will draw ISO 13485 further away from ISO 9001.

However, the original intent was to follow the meeting with an CD, but due to the volume of comments and the need to work in separate, in the end the experts were not really aware of the whole overview of the document. Due to that, it was agreed that we should circulate a second Working Draft in the beginning of November.

There will be and comment period of 2 and a half months, and we will then review the comments on the next WG 1 meeting (which will be together with the TC 210 plenary on the week of March 11 in Tokyo, Japan).

Besides this main topic, there were some updates from the IMDRF (more info on the website : <a href="http://www.imdrf.org/">http://www.imdrf.org/</a>)

Last edited by Marcelo Antunes; 18th October 2012 at 09:11 PM.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
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  Post Number #43  
Old 18th October 2012, 09:10 PM
red66climb's Avatar
red66climb

 
 
Total Posts: 31
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Thank you for the detailed update.
  Post Number #44  
Old 18th October 2012, 09:11 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,562
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

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

But it's interesting to note, due to the volume of changes, this revision will draw ISO 13485 further away from ISO 9001.
Marcelo, I heard that the next version of ISO 13485 will NOT follow the High Level Structure that ISO wants to use for all of their Management System Standards. Could you confirm that?
  Post Number #45  
Old 18th October 2012, 09:27 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,961
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Quote:
Marcelo, I heard that the next version of ISO 13485 will NOT follow the High Level Structure that ISO wants to use for all of their Management System Standards. Could you confirm that?

The problem is somewhat worse. It?s not that it won?t follow...ISO 13485 can?t follow the structure because it already deviates from some of the structure topics (eg. Continual improvement - and it?s a fundamental difference that is needed in the standard), so TC 210 asked the TMB to put in Guide 83 the possibility of deviation from the guide (after analysis by the TMB).
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #46  
Old 18th October 2012, 09:34 PM
Roland Cooke

 
 
Total Posts: 613
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Thanks very much for the updates Marcelo.
  Post Number #47  
Old 17th January 2013, 06:23 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,961
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

An update: WG 1 will meet in 11-13 MARCH 2013 in Japan (together with the TC 210 plenary) to continue the revision of ISO 13485. Comments for WD 2 were to be sent until yesterday.

Our mirror group in Brazil create more that 100 comments, and I expect that each commentator will have a lot of comments...so there will be a lot of work in Japan!
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #48  
Old 17th January 2013, 06:28 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,961
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Regarding our comments, I would like to share some so Covers could say what they think about them.

Origin: need to better integrate risk management into ISO 13485 (from WG revision list and comments from ISO 13485 survey)

Current WD2 text: in 4.1, item d) establish documented requirements for risk management throughout the quality management system

Comment:
Add a new item:
4.1 d) We need a separate risk management requirement.

Justification: it seems reasonable that the risk management is an important part of the quality management system, and should be incorporated in a separate item in 4.1 which gives an extended information and requirements for risk management through the quality management system requirements.

Proposed change

New item: 4.1.1 Risk Management
The organization shall establish, document, implement and maintain a continuous risk management process related to their medical devices during it’s lifecycle to identify the hazards and hazardous situations related to the medical device(s), estimate, assess and control those risks and evaluate the effectiveness of the risk control measures.

This risk management process shall include the elements of analysis, assessment, control and monitoring of production and post-production information and shall apply to the design of the medical device and to each related process.

Note: see ISO 14971 and ISO 24971

Last edited by Marcelo Antunes; 17th January 2013 at 07:06 PM.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
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