Jon M
16th February 2006, 05:28 PM
I am putting together an overview on ISO 13485:2003 for my company and am looking for the answer to this simple question that I am sure has been rehashed on this site in the past. Help is appreciated!
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View Full Version : Why ISO 13485 not ISO 9001 for medical devices? Al Rosen 16th February 2006, 05:39 PM I am putting together an overview on ISO 13485:2003 for my company and am looking for the answer to this simple question that I am sure has been rehashed on this site in the past. Help is appreciated!ISO 13485 has additional regulatory requirements for Medical Devices that ISO 9001 does not. For example, ISO 13485 requires more documented procedures than ISO 9001 and customer focus of ISO 9001 is satisfaction while iSO 13485 stresses customer requirements. You can find the comparison and reasons in appendix B of ISO 13485. Al Rosen 17th February 2006, 12:20 PM Jon, Aaron Lupo has a very nice power point presention posted here (http://elsmar.com/Forums/showpost.php?p=41110&postcount=2) that you will want to look at. Jon M 17th February 2006, 04:43 PM Wow, this presentation answers my question exactly! Thanks Al. Aaron Lupo 18th February 2006, 11:04 AM Jon, Aaron Lupo has a very nice power point presention posted here (http://elsmar.com/Forums/showpost.php?p=41110&postcount=2) that you will want to look at. Yes that presentation is pretty old at this point, I have not gone back and updated it. km214 26th September 2006, 01:15 PM Aaron, This ppt although old is still very helpful to those of us who are implementing ISO 13485. My company is restarting and I am in on the ground floor to establish quality systems. Prior to the restart the documentation was basic to say the least. The main headquarters for the company never implemented ISO 13485 and had failed the last customer audit. There was never an emphasis on QS or documentation. I am starting with again very basic documentation much of it is not specific to actual practice. It looks as if whoever had set the "system" up in the past had generated "ideal documents but over did things and the customer audit caught the lack of "real" implementation of the doc control system. I appreciate this ppt..it will help.. If you have more info that may assist me in my QS establishment, I would really appreciate it. I will watch this thread Thank You km214 29th November 2006, 05:14 PM Hello, Funny this question found me during my search. I was asked this question by our German QA consultant for our newest product in clinical trials. He ha never received the answer before meeting me, but it was indeed the correct answer. The key difference between 13485 and 9001 is that 9001 requires customer satisfaction monitoring and measurement, in 13485, as the products are medical devices that have already gone through rigorous clinical trials and has been proven to perform to requirements, this standard addresses customer feedback (IE: complaints product recalls etc..) I hope this helps |
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