Experimental Physics and
Industrial Control System

Andrew Johnson <[email protected]> · Fri, 10 Apr 2009 17:05:37 -0500

On Friday 10 April 2009 13:34:19 Emmanuel Mayssat wrote:
>
> I just received an interesting call from a stranger ;-) on this mailing
> list. He asked me about FDA approval and ISO certification when you are
> selling solution that uses EPICS and GPL software.
> I could not properly answer his question...
>
> I believe to be ISO certified, your suppliers NEED to be ISO certified
> as well. But what happens if you use epics or GPL software?
> Can you still be ISO certified?
>
> Any idea who is the best person to ask?

You need to talk to someone who has experience with FDA approval and/or 
ISO-9000 certification, because I don't think anyone in the EPICS community 
can answer that question other than to say we aren't compliant.  The 
development and testing procedures for EPICS Base are almost certainly not 
documented to those standards, and we have no plans to make them comply.

I guess it might be possible to use software that was not developed with 
ISO-9000 procedures within a product that does meet that standard if you 
develop and apply suitable tests to the software before you use it (or to the 
product itself), but you would need to ask an ISO-9000 expert about that 
issue and I am most certainly not one.

Sorry, I don't think anyone here will be able to help much,

- Andrew
-- 
The best FOSS code is written to be read by other humans -- Harold Welte

Experimental Physics and Industrial Control System

Experimental Physics and
Industrial Control System