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26th June 2007, 10:47 AM
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Inactive Registered Visitor
Registration Date: May 2007
Location: SOUTH FLORIDA
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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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Thank You to TJG954 for your informative Post and/or Attachment!
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26th June 2007, 10:58 AM
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Re: ISO 13485 - List of required / needed procedures and records attached
Quote:
In Reply to Parent Post by TJG954
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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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!  
__________________
Gidget Stough, ASQ CQA
"It's easier to do a job right than to explain why you didn't." - Martin Van Buren
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Thank You to GStough for your informative Post and/or Attachment!
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24th February 2012, 01:51 PM
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Re: ISO 13485 - List of required / needed procedures and records attached
Thank you this is very helpful! Acchi Larka
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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.
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24th February 2012, 03:23 PM
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Re: ISO 13485 - List of required / needed procedures and records attached
Quote:
In Reply to Parent Post by cartman1417
Thank you ISO MAN. This is quite useful for ISO newbies like me.
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ISO Man has not checked in here since 5th December 2010.
I hope he'll get your thanks when he returns.. 
Stijloor, Forum Moderator.
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24th February 2012, 05:53 PM
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Re: ISO 13485 - List of required / needed procedures and records attached
Quote:
In Reply to Parent Post by Stijloor
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
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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
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9th July 2012, 07:02 AM
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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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