MDSAP and Procedure Format

#1
I am currently in the middle of a gap analysis for MDSAP implementation and I am curious as to how I should format my procedures for this.

Am I required to specifically reference the individual country requirements on the procedure in the references section (i.e. TG, RDC, MHLW, and QSR- in addition to 13485)? Or, alternatively, are you just referencing MDSAP guidance doc there?

Or should the individual country requirements have separate sections with in the SOP maybe?

But then again if MDSAP is an audit methodology, maybe you really do have reference each individual country regulation in the reference section...
 
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Ronen E

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#2
I am currently in the middle of a gap analysis for MDSAP implementation and I am curious as to how I should format my procedures for this.

Am I required to specifically reference the individual country requirements on the procedure in the references section (i.e. TG, RDC, MHLW, and QSR- in addition to 13485)? Or, alternatively, are you just referencing MDSAP guidance doc there?

Or should the individual country requirements have separate sections with in the SOP maybe?

But then again if MDSAP is an audit methodology, maybe you really do have reference each individual country regulation in the reference section...
In my understanding the idea behind MDSAP is to consolidate and unify, not just to bunch together numerous items. That means you should address it in a manner as general as practicable. If I was to prepare an SOP for that purpose, I would just include pointers to where specific information can be found, and I'd try to make those pointers not too specific so that they survive over time. Then I would maybe add an appendix or a completely separate supporting document that lists the relevant markets - so that when these change, the main SOP wouldn't have to.

Whoever would be responsible for implementation / compliance would need to look up the markets list and identify the applicable specific requirements with the aid of (hopefully generic) guidance and pointers included in the SOP for that purpose. It's not exactly spoon feeding but people tend to be intelligent sometimes.

I hope I'm getting the message across rather than just confusing...

Cheers,
Ronen.
 
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