ISO 9001, FDA QSR GMP Matrix

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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 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. IP: Logged
ISO GUY Forum Contributor Posts: 81 From:Rochester, NY Registered: Jan 2000	posted 19 March 2001 02:21 PM I would also be interested in a copy. IP: Logged
romelnar Forum Contributor Posts: 15 From:alabang, philippines Registered: Mar 2001	posted 19 March 2001 09:19 PM hey guys! may i just know whats FDA, QSR and GMP stand for. thanks. IP: Logged
Marc Smith Cheech Wizard Posts: 4119 From:West Chester, OH, USA Registered:	posted 20 March 2001 05:53 AM 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).] IP: Logged
dWizard Forum Contributor Posts: 20 From:Normandy, TN 37360 Registered: Mar 2001	posted 23 March 2001 08:05 AM 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. IP: Logged
Marc Smith Cheech Wizard Posts: 4119 From:West Chester, OH, USA Registered:	posted 23 March 2001 08:49 AM It's posted. IP: Logged
kaliweb Lurker (<10 Posts) Posts: 7 From:Kansas City, KS, USA Registered: Mar 2001	posted 23 March 2001 09:53 AM Where is it posted? IP: Logged
Marc Smith Cheech Wizard Posts: 4119 From:West Chester, OH, USA Registered:	posted 23 March 2001 10:07 AM Look for isovsqsrvsiso2000.doc in the pdf_files directory. IP: Logged
ISO GUY Forum Contributor Posts: 81 From:Rochester, NY Registered: Jan 2000	posted 23 March 2001 12:42 PM 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. IP: Logged

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