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Gap Analysis Checklist for ISO 13485:2003 2012 - Page 2


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  Post Number #9  
Old 14th November 2012, 04:12 PM
ISO assistance

 
 
Total Posts: 2
Re: Gap Analysis Checklist for ISO 13485:2003 2012

DR RA,

Were you able to locate a Gap Analysis Checklist for ISO 13485:2003 2012; I am looking for the same thing and have not had any luck thus far.

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  Post Number #10  
Old 14th November 2012, 04:14 PM
ISO assistance

 
 
Total Posts: 2
Re: Gap Analysis Checklist for ISO 13485:2003 2012

In search of a GAP analysis for EN ISO 13485:2003-2012. Any assistance would be greatly appreciated.

Thank you in advance.
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  Post Number #11  
Old 14th November 2012, 04:21 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,456
Let Me Help You Re: Gap Analysis Checklist for ISO 13485:2003 2012

Quote:
In Reply to Parent Post by ISO assistance View Post

In search of a GAP analysis for EN ISO 13485:2003-2012. Any assistance would be greatly appreciated.

Thank you in advance.
You can create one easily. Take the standard and write in front of each requirement the words, "Do we do this?"

In a spreadsheet, make a column for each requirement, then one of the answer and any explanation of something done partially, or ineffectively.
  Post Number #12  
Old 15th November 2012, 08:49 AM
Dr RA

 
 
Total Posts: 21
Re: Gap Analysis Checklist for ISO 13485:2003 2012

This is what I have done for the Gap Analysis: Hope u can do similar to this
In March 2012, BS EN ISO 13485:2012 was published, following European publication in February. This version will only be applicable within Europe and is expected to be harmonised by the end of summer 2012. For the rest of the world, ISO13485:2003 will remain the applicable standard.
What is the difference between EN ISO 13485:2012 and ISO 13485:2003?
The only changes to the new 2012 standard are within the forward and Annex Z?s. There has been no change to the Normative Text, i.e. the requirements of the standard remain unchanged from the 2003 version.
The revision to the (informative) Annex Z?s was made to provide greater clarity on the applicability and alignment of clauses of ISO 13485 with the quality systems requirements of each of the three Medical Device Directives (AIMD, MDD and IVD). The new Annex Zs each cover a different Annex (Conformity Assessment Route) within one of the Medical Directives. For example, Annex ZB of BS EN ISO 13485 shows the relationship between the Medical Device Directive 93/42/EEC Annex II, Full Quality Assurance and the clauses of EN ISO 13485.
Quality Management Standards
EN ISO 13485:2012 and ISO13485:2003, are based on the ISO9001:2000 process model approach. These standards provide a good base Quality Management Systems model for compliance with the following:
1. EU CE marking medical device directives
2. Health Canada CMDCAS
3. Taiwan Medical device Regulations
4. Other international regulatory requirements.

As there are no change to the requirements of ISO13485 standard, no amendments are required to QMS.
Thanks to Dr RA for your informative Post and/or Attachment!
  Post Number #13  
Old 17th March 2015, 01:56 PM
MIXOLYDIAN

 
 
Total Posts: 7
Re: gap analysis checklist for ISO 13485:2003 2012

For those of us who sell medical devices to EU, there is an EN ISO 13485:2012 that we must conform to. We are going to be re-certified and were advised by our NB to use the new EN 13485.
No shortcuts here to find a Gap Checklist.
My advice; set the standards, 2003 & 2012, side by side and enjoy the ride (that's what I'm currently doing).
  Post Number #14  
Old 17th March 2015, 06:17 PM
Ronen E

 
 
Total Posts: 2,635
Re: gap analysis checklist for ISO 13485:2003 2012

Quote:
In Reply to Parent Post by MIXOLYDIAN View Post

For those of us who sell medical devices to EU, there is an EN ISO 13485:2012 that we must conform to. We are going to be re-certified and were advised by our NB to use the new EN 13485.
No shortcuts here to find a Gap Checklist.
My advice; set the standards, 2003 & 2012, side by side and enjoy the ride (that's what I'm currently doing).
1. No one has to conform with EN ISO 13485 in order to sell medical devices in the EC. It's just a preferred way. This is true for all harmonized standards.

2. There is no difference in the requirements between ISO 13485:2003 and EN ISO 13485:2012.
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