ISO 9001, FDA QSR GMP Cross Reference Matrix

K

kaliweb

#1
ISO 9001, FDA QSR GMP Matrix

Hello, I am new to ISO.

Does anyone out there have a matrix that shows the ISO 9001 2000, ISO 9001 1994, FDA QSR, FDA GMP requirements and how they relate to each other.

I am seeking some kind of way to compare each requirement in these standards.

We are trying to get ISO 9001 2000 and FDA QSR GMP certified.

Email me. Thanks.
 
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Marc

Fully vaccinated are you?
Leader
#4
We're all interested but no one has one! Oh, well!

GMP = Good manufacturing Practices
FDA = Food and Drug Administration
QSR = Quality Systems Requirements (?)

[This message has been edited by Marc Smith (edited 23 March 2001).]
 
D

Don Winton

#5
This is what I have.

In Word 2000 Format:

In the left hand column is the QSR requirements, listed in order;
The next column lists the applicable ISO 9001:1994 description;
The next column lists the applicable ISO 9001:1994 requirements;
The next column lists the applicable ISO 9001:2000 requirements;
The next column lists the applicable ISO 9001:2000 description.

The QSR versus ISO stuff I did; the ISO:1994 versus ISO9001:2000 is from Annex B of ISO 9001:2000.

I will send Marc a copy and he can post it.

Regards,

dWizard

------------------
I was better but I got over it.
 
A

Aaron Lupo

#9
This is a handy little matrix. I was wondering if anyone out there has a file that compares the requirements of ISO to the QSR? I know they are similar but there are some differnces. If nobody has one I will try and put one toghther.
 
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