Gap Analysis Checklist for ISO 13485:2003 2012

D

Dr RA

Can any one share gap analysis for ISO 13485:2003 to ISo 13485:2012 please.

Thanks a lot

RA
 
B

Boingo-boingo

Dr. RA, good news.

As mentioned here, numerous times, there is NO ISO 13485:2012. So, there is no gap, no need for a gap analysis. Nothing to change, zero.
 
D

Dr RA

But my auditor has asked for a gap analysis in the first audit?!!!
 
B

Boingo-boingo

Makes you wonder about your auditor competence and knowledge, doesn't it? :nope:
 
C

c.mitch

Quite Involved in Discussions
Yes there is a gap.
In the previous versions, the annexes ZA, ZB & ZC weren't detailed.
In EN ISO 13485:2012, there is a traceability matrix between the directives and the standard.
This is IHMO were resides the gap analysis.
If you already have the CE mark, though, this should be probably unnecessary since the CE mark means conformity to the EU regulations.
 
Stijloor

Stijloor

Leader
Super Moderator
It's not getting easier in standards land. :(
The proliferation of standards is rampant! :(

Just my :2cents:
 
I

ISO assistance

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.
 
I

ISO assistance

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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