Jim, this is an excellent subject. While I'm very `meticulous' when
it comes to documentation, I have not studied the ISO900x standards in
detail. I'm looking forward to this topic.

   - Tom

At 09:23 AM 3/3/98 -0000, you wrote:
>I have a topic here that should be of interest to anyone doing code
>development.  If you are not familiar with this already, chances are you
>will be in the near future.
>
>ISO900
>
>For software developers, yes firmware as well. BTW if you are developing a
>product that will need FDA approval, the FDA is now starting to take a
>closer look at firmware.
>
>What does this all mean, document, document, document.
>
>How many of you have in place, have created, or plan on creating a
>'Procedure detailing the process for firmware development'?
>
>I am hoping we can share some details of plans already created that work.
>
>I work for a company that designs medical equipment, these devices require
>both FDA and ISO documentation.  I am now starting a plan to create firmware
>procedures.  Part of my plan is to look at existing procedures for guidance.
>To begin with I found a book called "Software Quality", ISBN 0-201-63198-9
>that has plenty of good information on providing a skeletal outlook.  I have
>an idea of what the procedures need, but I would like to hear from others on
>what they think or have experienced.
>
>Here are the ISO Standards that I believe pertain to software/firmware
>development.
>ISO9001      Quality Systems
>ISO9000-3  Guidelines for the Application
>ISO9004-2  Quality Management
>ISO9004-4  Quality Management and Quality System Elements
>
>If this seems like a dry and overwhelming topic, that is probably because it
>is.  But unfortunately that does not detract from its importance.
>
>Take care  -Jim
>
>