Hi,

Boy am I frustrated! I have a lot of experience in the Q&R field, but am currently in a small company and need to develop an ISO 9001, ISO 13485 & FDA QSR compliant quality system. Since I'm not a big fan of typing and I have some serious resource constraits, I'm looking for available tools that I can purchase to use as a framework for defining the quality system of this business. The reason that I am frustrated is that I just purchased software from a company that said they had a quality system that would be simple and small and meet our needs perfectly. When I looked at it, the quality manual alone was 122 pages (and this was just ISO 9001 & QSR, I was going to add the delta for 13485).

Does anyone have a suggestion as to where I can purchase software that I can use that is small, simple and ensures that the regulations requirements are coverred. At this point, I'm considering writing the whole thing, but hope that I won't need to.

Any help would be appreciated. Thanks. :bonk:

Hi,

Boy am I frustrated! I have a lot of experience in the Q&R field, but am currently in a small company and need to develop an ISO 9001, ISO 13485 & FDA QSR compliant quality system. Since I'm not a big fan of typing and I have some serious resource constraits, I'm looking for available tools that I can purchase to use as a framework for defining the quality system of this business. The reason that I am frustrated is that I just purchased software from a company that said they had a quality system that would be simple and small and meet our needs perfectly. When I looked at it, the quality manual alone was 122 pages (and this was just ISO 9001 & QSR, I was going to add the delta for 13485).

Does anyone have a suggestion as to where I can purchase software that I can use that is small, simple and ensures that the regulations requirements are coverred. At this point, I'm considering writing the whole thing, but hope that I won't need to.

Any help would be appreciated. Thanks. :bonk:
Hi QT:
I don't know what experience you have with the FDA QSR but you might want to write your procedures around the FDA Requirements and your Quality Manual organized around 13485. They are pretty much "harmonized". I did this and provided a cross reference to the QSR in the Quality Manual.

You may find this thread helpful:
http://elsmar.com/Forums/showthread.php?t=6160&page=2&pp=15
as well as some others in the Cove. Try doing a search.

This web page may also help:
http://www.clinivation.com/pages/resources/downloads.htm

Post any other specific questions. I don't think you will be happy with anything that's "canned" and you will still need to work on it. BTW, did you get your money back?

No, I didn't get my money back. This URL that you pointed me to has some templates that it says are available for use and then in the legal section it talks (as I would expect) that the information is copyright protected. Do you know if these are available for use, free of charge? It doesn't feel right. If it looks too good to be true, it probably is.

No, I didn't get my money back. This URL that you pointed me to has some templates that it says are available for use and then in the legal section it talks (as I would expect) that the information is copyright protected. Do you know if these are available for use, free of charge? It doesn't feel right. If it looks too good to be true, it probably is.
I wouldn't think you could use anything without modification. I just thought the templates would give you some insight as to the requirements and as a starting point for your procedures. Why not call them to discuss the limits of the use of the templates. After all they are available for download and are in MSWORD. Of course be prepared for a sales pitch. I would think the templates could be used for the purpose of developing procedures. But since I'm not a lawyer, I don't know what is covered by their copyright.

Here's a cross-reference that I put together that maps FDA QSRs alongside ISO 13485:2003 and ISO 9001:1994. Hope this helps. It is not copyrighted. Looking at the dates, you're probably well past this now.
I'm now where you were.
Has anyone flowcharted the four main processes of 13485 showing their interconnections? Ditto not wanting to recreate the wheel... Oh, the 4 processes I'm referring to are: QMS, Managment Responsibility, Product Realization and Measurement, analysis and improvement.

Thanks. :)