GMP CFR 820 - ISO 13485 comparison

B

bjmay

#1
I'm in the process of validating our Quality System for compliance with GMP CFR 820. I'm looking for a comparison chart of ISO13485 and the GMP document. Any assistance would be appreciated. I did notice a site member "howste" referenced one for download but I was unable to access it.
 
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Stijloor

Staff member
Super Moderator
#2
I'm in the process of validating our Quality System for compliance with GMP CFR 820. I'm looking for a comparison chart of ISO13485 and the GMP document. Any assistance would be appreciated. I did notice a site member "howste" referenced one for download but I was unable to access it.
Can anybody help?

Stijloor.
 
B

bjmay

#5
Doug,

Thanks - these will save me from many sleepless nights. Wish I had found this site / forum sooner!:biglaugh:

FYI - unable to open "Correspondence between 13483, GMP, 820" appears to be corrupted or I'm not smart enough to figure out how to open it!!

Your help is "Greatly appreciated.

Betty
 
M

MDQSA

#6
You can purchase the following document from BSI for about $80:
"Comparison Matrix: ISO 13485:2003 and Medical Device Regulations"
It includes 21CFR 820, SOR/98-282 (Canadian), 93/42/EEC (European) and JPAL (Japan).
There are a few errors, but it certainly helps to not re-invent the wheel. :2cents:
 

howste

Thaumaturge
Super Moderator
#7
I'm in the process of validating our Quality System for compliance with GMP CFR 820. I'm looking for a comparison chart of ISO13485 and the GMP document. Any assistance would be appreciated. I did notice a site member "howste" referenced one for download but I was unable to access it.
Do you have Adobe Acrobat Reader installed? If not, you might have problems. I've posted a couple of versions of the comparison....

Here's the PDF version: 820 - ISO 13485-2003 Comparison Matrix.pdf

Here's the MS Word version: 820 - ISO 13485-2003 Comparison Matrix.doc
 
B

bjmay

#9
Thanks everyone, I was able to obtain some very useful materials that will make the transistion easier. Good to know that there is a "Team" of Quality personnel lending a hand / sharing knowledge to ensure success for all of us.

I'll will update you once the process is completed and we accomplish a successful FDA manufacturing inspection.


:thanx:
 
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