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iso 13485 - medical device qms, required procedures
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  #17  
Old 26th June 2007, 10:47 AM
TJG954 - 2009 TJG954 - 2009 is offline
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Re: ISO 13485 - List of required / needed procedures and records attached

My company is FDA regulated and we're not ISO, so I tried to do a comparison list. I thought it might help those that are in the same boat (plugging leaks) as me.

Suggestions are always welcomed.
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File Type: xls Comparison ISO-CFR820.xls (23.5 KB, 663 views)
Thank You to TJG954 - 2009 for your informative Post and/or Attachment!

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Old 26th June 2007, 10:58 AM
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Re: ISO 13485 - List of required / needed procedures and records attached

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In Reply to Parent Post by TJG954 View Post

My company is FDA regulated and we're not ISO, so I tried to do a comparison list. I thought it might help those that are in the same boat (plugging leaks) as me.

Suggestions are always welcomed.
Looks good, Ted!

A couple of years ago I developed a similar matrix to help me understand our processes as they relate to ISO 9001:2000, 13485:2003 and FDA's CFR 820 QSR. I think I like yours better!
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File Type: xls QSR ISO 9001-13485 Matrix.xls (249.5 KB, 802 views)

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  #19  
Old 24th February 2012, 01:51 PM
Acchi Larka Acchi Larka is offline
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Re: ISO 13485 - List of required / needed procedures and records attached

Thank you this is very helpful! Acchi Larka
  #20  
Old 24th February 2012, 03:16 PM
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Re: ISO 13485 - List of required / needed procedures and records attached

Thank you ISO MAN. This is quite useful for ISO newbies like me.
  #21  
Old 24th February 2012, 03:23 PM
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Re: ISO 13485 - List of required / needed procedures and records attached

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Thank you ISO MAN. This is quite useful for ISO newbies like me.
ISO Man has not checked in here since 5th December 2010.

I hope he'll get your thanks when he returns..

Stijloor, Forum Moderator.
  #22  
Old 24th February 2012, 05:53 PM
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Re: ISO 13485 - List of required / needed procedures and records attached

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In Reply to Parent Post by Stijloor View Post

ISO Man has not checked in here since 5th December 2010.

I hope he'll get your thanks when he returns..

Stijloor, Forum Moderator.

......i missed that part :P
  #23  
Old 13th June 2012, 07:50 AM
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Re: ISO 13485 - List of required / needed procedures and records attached

Thanks for the great, 1 stop review of the requirements
MantleMickey
  #24  
Old 9th July 2012, 07:02 AM
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BIG Smile Re: ISO 13485 - List of required / needed procedures and records attached

Thank you ISO MAN! What a great list ..Sweet and simple...
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