Comparison of ISO 13485, FDA and JGMP

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S

starbuck1

#33
Hello,

This is a bit of an older post, but I am trying to track down the original compiler of this 21 CFR 820-ISO 13485 table (NOT the one with the jGMP addition)...is it Ed Kimmelman? It seems that everyone is using what I can only figure is the original Kimmelman chart as a base and adding other regulations onto it (such as jGMP, etc). This is all fine and good, except there are a few errors in the original chart that keep perpetuating, and it is really easy to tell who just copied and pasted the original. (It's also driving me bonkers, hence my need to post about it.)

It would really help to cite the original chart if you've made additions for your own purposes. That way we can more easily trace back where the errors came from.

Thanks!
 

Marcelo

Inactive Registered Visitor
#34
Hello,

This is a bit of an older post, but I am trying to track down the original compiler of this 21 CFR 820-ISO 13485 table (NOT the one with the jGMP addition)...is it Ed Kimmelman? It seems that everyone is using what I can only figure is the original Kimmelman chart as a base and adding other regulations onto it (such as jGMP, etc). This is all fine and good, except there are a few errors in the original chart that keep perpetuating, and it is really easy to tell who just copied and pasted the original. (It's also driving me bonkers, hence my need to post about it.)

It would really help to cite the original chart if you've made additions for your own purposes. That way we can more easily trace back where the errors came from.

Thanks!
Hello, and welcome to the Cove!

I?m not sure where it came from (it?s been a lot of years now) but I "think" that i comes from the original Ed Kimmelman comparison chart.

Please note, even if that?s the case, people creating those are in principle trying to help "freely" (and people reading those should be aware that it may not be correct), and it may be inpractical to expect that they would really be that much worried about traceability (althought I agree with the comment in principle).
 

Marcelo

Inactive Registered Visitor
#35
Oh, and anyone can obviously help even more by correcting the existing ones and sharing it here (although with the proximity of the revision I?m not sure it would be thattttt helpful at this time - well, I think it can always be to at least some people, anyway) :p
 
Last edited:
S

starbuck1

#36
Thanks! I totally agree with sharing edits to help others, I'm in no way saying no to that. :) I have an auditor's eye, and I just wanted to mention it for future reference. :)
 
S

starbuck1

#37
Related to this point, does anyone know when the revision will come out? I know they said 2014, but has anyone heard exactly when?
 
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