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  ISO 9001/4:2000
  ISO 9001, FDA QSR GMP Matrix

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Author Topic:   ISO 9001, FDA QSR GMP Matrix
kaliweb
Lurker (<10 Posts)

Posts: 7
From:Kansas City, KS, USA
Registered: Mar 2001

posted 09 March 2001 12:37 PM     Click Here to See the Profile for kaliweb   Click Here to Email kaliweb     Edit/Delete Message   Reply w/Quote
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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ISO GUY
Forum Contributor

Posts: 81
From:Rochester, NY
Registered: Jan 2000

posted 19 March 2001 02:21 PM     Click Here to See the Profile for ISO GUY   Click Here to Email ISO GUY     Edit/Delete Message   Reply w/Quote
I would also be interested in a copy.

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romelnar
Forum Contributor

Posts: 15
From:alabang, philippines
Registered: Mar 2001

posted 19 March 2001 09:19 PM     Click Here to See the Profile for romelnar   Click Here to Email romelnar     Edit/Delete Message   Reply w/Quote
hey guys! may i just know whats FDA, QSR and GMP stand for. thanks.

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 20 March 2001 05:53 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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).]

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dWizard
Forum Contributor

Posts: 20
From:Normandy, TN 37360
Registered: Mar 2001

posted 23 March 2001 08:05 AM     Click Here to See the Profile for dWizard   Click Here to Email dWizard     Edit/Delete Message   Reply w/Quote
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.

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
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posted 23 March 2001 08:49 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
It's posted.

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kaliweb
Lurker (<10 Posts)

Posts: 7
From:Kansas City, KS, USA
Registered: Mar 2001

posted 23 March 2001 09:53 AM     Click Here to See the Profile for kaliweb   Click Here to Email kaliweb     Edit/Delete Message   Reply w/Quote
Where is it posted?

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 23 March 2001 10:07 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Look for isovsqsrvsiso2000.doc in the pdf_files directory.

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ISO GUY
Forum Contributor

Posts: 81
From:Rochester, NY
Registered: Jan 2000

posted 23 March 2001 12:42 PM     Click Here to See the Profile for ISO GUY   Click Here to Email ISO GUY     Edit/Delete Message   Reply w/Quote
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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