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ISO 13485:2015 Pre-Release News and Discussion - Page 15


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  Post Number #113  
Old 27th July 2014, 02:03 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,037
Re: ISO 13485:2015 Pre-Release News and Discussion

Quote:
If we want to get the comments, where can I get?
In principle, you can?t. The comments are circulated to WG1 members. However, if you are part of your country NC or mirror WG, you could get the document from them.

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  Post Number #114  
Old 5th August 2014, 12:36 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: ISO 13485:2015 Pre-Release News and Discussion

I?m just changing the year of the title of this thread because, due to the negative vote to the DIS, the revision won?t be published in 2015 anymore.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
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  Post Number #115  
Old 5th August 2014, 11:19 PM
stevenking

 
 
Total Posts: 9
Re: ISO 13485:2015 Pre-Release News and Discussion

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In Reply to Parent Post by Marcelo Antunes View Post

I?m just changing the year of the title of this thread because, due to the negative vote to the DIS, the revision won?t be published in 2015 anymore.
just for the reason, which the structure of ISO 13485:201X is different from that of ISO 9001:2015? or other main rationale?
  Post Number #116  
Old 6th August 2014, 12:33 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,037
Re: ISO 13485:2016 Pre-Release News and Discussion

Quote:
just for the reason, which the structure of ISO 13485:201X is different from that of ISO 9001:2015? or other main rationale?]
They are totally different, ISO 13485 will keep the old 2003 structure, and ISO 9001 changed completely.

Last edited by Stijloor; 6th August 2014 at 12:41 AM. Reason: Fixed quote and typo.
  Post Number #117  
Old 8th August 2014, 01:52 PM
Reg Morrison

 
 
Total Posts: 433
Re: ISO 13485:2015 Pre-Release News and Discussion

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

I?m just changing the year of the title of this thread because, due to the negative vote to the DIS, the revision won?t be published in 2015 anymore.
Marcelo, many thanks for keeping us informed of the progress of the ISO 13485 revision.

It is very interesting (in my opinion) that the ISO TC 210 is taking the revision process very seriously, taking time and even not following the HLS for the ISO 13485 revision.

In contrast, it seems to me that the ISO TC 176 is determined to have the ISO 9001 revision completed by the deadline they self imposed of September 2015.

With all the respect that ISO 13485 deserves, in terms of user-organizations, it pales against the 1.2 million ISO 9001 certified organizations around the World. The greed to start selling millions of ISO 9001 copies ASAP might be impacting the ISO TC 176 risk management process and they might deliver a half-baked document.

I find very telling the difference of approaches between the TC 176 and TC 210 when it comes to their flagship standards revision process.
  Post Number #118  
Old 8th August 2014, 01:59 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,037
Re: ISO 13485:2016 Pre-Release News and Discussion

Quote:
Marcelo, many thanks for keeping us informed of the progress of the ISO 13485 revision.

It is very interesting (in my opinion) that the ISO TC 210 is taking the revision process very seriously, taking time and even not following the HLS for the ISO 13485 revision.

In contrast, it seems to me that the ISO TC 176 is determined to have the ISO 9001 revision completed by the deadline they self imposed of September 2015.

With all the respect that ISO 13485 deserves, in terms of user-organizations, it pales against the 1.2 million ISO 9001 certified organizations around the World. The greed to start selling millions of ISO 9001 copies ASAP might be impacting the ISO TC 176 risk management process and they might deliver a half-baked document.

I find very telling the difference of approaches between the TC 176 and TC 210 when it comes to their flagship standards revision process.
Part of the difference is crucial - ISO 13485 has been created to be used for regulatory purposes and thus need consensus by the regulators that will use it.

Some of the main reasons for the negative vote at the DIS were just this - some disagreements on it?s usefulness in the future by regulators (including it?s use in the MDSAp program).

Hopefully we can solve most or all of the disagreements on September.

Last edited by Marcelo Antunes; 8th August 2014 at 02:33 PM.
  Post Number #119  
Old 13th August 2014, 11:54 AM
MantleMickey

 
 
Total Posts: 35
Re: ISO 13485:2016 Pre-Release News and Discussion

Marcelo, I just wanted to thank you also for keeping us up to date on the

ISO revisions. This site is where I go to see the most current updates.
We all appreciate you and what you do for us. You're the best!
Thanks to MantleMickey for your informative Post and/or Attachment!
  Post Number #120  
Old 13th August 2014, 01:39 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: ISO 13485:2016 Pre-Release News and Discussion

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

...some disagreements on it?s usefulness in the future by regulators (including it?s use in the MDSAp program).
FDA recently called to ask me/my employer to participate in MDSAP (Medical Device Single Audit Pilot Program).

Is anyone else here participating in US FDA MDSAP, or signed up to do so?
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