GMP CFR 820 - ISO 13485 comparison

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.

bjmay said:

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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Can anybody help?

Stijloor.

This must be the post you are looking for. And this is the thread: ISO 13485 vs. GMP - Is there a difference between ISO 13485 and GMP?

Here's a few different versions:

View attachment 820ISO13485-ComparisonMatrix[1].pdf

View attachment AuditChecklist13485_21cfr820[1].doc

View attachment Correspondence between ISO 13485, FDA 820 and JGMP.doc

View attachment fda13485guidebook.pdf

Doug,

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

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

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.

bjmay said:

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.

Click to expand...

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

howste said:

Do you have Adobe Acrobat Reader installed? If not, you might have problems.

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The free Foxit Reader is recommended as an alternative to the bloated and slow Adobe reader.

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.

Doug Tropf said:

Here's a few different versions:

View attachment 10784

View attachment 10785

View attachment 10786

View attachment 10787

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thank you so much, I am looking for this.