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.
 

Marc

Fully vaccinated are you?
Staff member
Admin
#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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