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Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
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ISO 13485 Revision - User Requirements Survey for ISO 13485 revision


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iso 13485 - medical device qms, iso 14969 (medical devices - application of iso 13485)
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  Post Number #1  
Old 27th May 2011, 04:03 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,544
Look! ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

As i mentioned some time ago, it was decided to revise ISO 13485.

The below information was distributed to members of ISO TC 210 WG 1:

"Below is a link to a survey that is to be completed by existing users and/or potential users of ISO 13485 2003 and users of other Medical Device Quality Management Systems. The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003 requirements standard and the ISO/TR 14969:2004 guidance document.

Please complete the following survey by 31 August 2011:

ISO TC210 WG 1 ISO 13485 Revision User Requirements Survey

Please feel free to forward the survey to any medical device firms, government agencies, competent authorities, registrars, industrial organizations and consultants that are appropriate. The survey should take approximately 30 minutes to complete and the deadline is 31 August 2011."
Thank You to Marcelo Antunes for your informative Post and/or Attachment!

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  Post Number #2  
Old 4th November 2011, 12:57 PM
JohnM's Avatar
JohnM

 
 
Total Posts: 25
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Has this August 31st deadline been extended? I thought it had.
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  Post Number #3  
Old 4th November 2011, 10:31 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,544
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Not really extended...but it's been reopened until january 2012 - on this link: http://www.zoomerang.com/Survey/WEB22CB9ZPRRSP

Last edited by howste; 6th November 2011 at 11:10 AM. Reason: Fixed web link.
  Post Number #4  
Old 21st June 2012, 09:04 AM
Asiah

 
 
Total Posts: 7
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Hi!
Thanks for sharing. I tried clicking on the link but
the survey is closed.

Newbie,
Asiah
  Post Number #5  
Old 21st June 2012, 09:05 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,544
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Quote:
Hi!
Thanks for sharing. I tried clicking on the link but
the survey is closed.

Newbie,
Asiah
Hello, Asiah, the survey closed on January 2012.
  Post Number #6  
Old 21st June 2012, 09:08 AM
Asiah

 
 
Total Posts: 7
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Yess.. did not read the text carefully.
How about the ISO 9000:2005 when is the next
upgrade? Any info.

Thanks
  Post Number #7  
Old 21st June 2012, 09:20 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,544
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Quote:
Yess.. did not read the text carefully.
How about the ISO 9000:2005 when is the next
upgrade? Any info.
There's a discussion thread on the revision of ISO 9001 here: http://elsmar.com/Forums/showthread.php?t=30496
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #8  
Old 21st June 2012, 10:23 AM
Asiah

 
 
Total Posts: 7
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Thanks..
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