Matrix for Documented Procedures (US FDA Part 820, ISO 13485 and ISO 9001)

[Tiffany]

Hi mates,

Is there any matrix developed for the documented procedures as required by the US FDA Part 820, ISO 13485:2003 and ISO 9001:2008?

Thanks )

TIff ....oo0oo....

[bio_subbu]

In Reply to Parent Post by Tiffany

Hi mates,

Is there any matrix developed for the documented procedures as required by the US FDA Part 820, ISO 13485:2003 and ISO 9001:2008?

Thanks )

TIff ....oo0oo....

Refer the Existing thread "Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets" post #30.

[regqual]

Hi Tiffany,

I am seeking the same/similar matrix: FDA 21CFR Part 820 vs. ISO 9001:2008 vs ISO 13485:2003 - GMP would be a plus. Did you find one? As someone else mentioned, I don't want to reinvent if it exists. Your assistance is appreciated.

[QA-Man]

Here's one I posted some time ago. Still good.