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Gap Analysis of ISO 9001 to ISO 13485


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consultants and consulting, gap analysis, implementing iso 13485, iso 13485 - medical device qms
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  Post Number #1  
Old 17th June 2014, 05:04 PM
QA Bee

 
 
Total Posts: 8
Please Help! Gap Analysis of ISO 9001 to ISO 13485

Hi Everyone,
I hope I am posting this in the correct forum.

We are small IVD company looking at upgrading our QMS to ISO 13485 this year. Our current QMS is compliant w/ ISO 9001:2008.

We would like someone to do Gap Analysis for us and determine the changes and what needs to be change and assist with implementation of ISO 13485.
Can anyone make a recommendation on an individual or company in the Western part of the US? We are looking for some assistance pretty soon if someone is able to give some reference.


Thank you So much for help in advance.

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  Post Number #2  
Old 17th June 2014, 05:14 PM
Ronen E

 
 
Total Posts: 3,225
Re: Gap Analysis of ISO 9001 to ISO 13485

http://elsmar.com/Forums/member.php?u=12959
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  Post Number #3  
Old 17th June 2014, 05:20 PM
Marc's Avatar
Marc

 
 
Total Posts: 25,680
Re: Gap Analysis of ISO 9001 to ISO 13485

Thread moved to the ISO 10019 - Consultants and Consulting forum.
  Post Number #4  
Old 6th January 2015, 08:13 PM
QA Bee

 
 
Total Posts: 8
Re: Gap Analysis of ISO 9001 to ISO 13485

Still looking for Consultants or Consulting Firm in Bay Area, CA.
  Post Number #5  
Old 7th January 2015, 02:43 PM
Mark Meer

 
 
Total Posts: 598
Re: Gap Analysis of ISO 9001 to ISO 13485

haha, just finished posting in this thread on the same topic.

My suggestion (if you haven't done so already) is to purchase a copy of ISO 13485, and take a look at Annex B. It is a really comprehensive table that describes exactly what the differences are, clause by clause, between 9001 and 13485.
Thanks to Mark Meer for your informative Post and/or Attachment!
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