When I visit R&D center,I found some software.this was used for verification of Design. This program is used for analysis of Base Foundation strength. Should this be calibrated or not.If so,where can I find the ISO clouse? I think this should be calibrated. But there is no detail description in ISO 9001.Only described for product related.

I would think the software would come 'certified'. Since software is fixed (except the case of revision) I would think there is nothing to calibrate.

See 4.11.1 first paragraph.

"The supplier shall ... control, calibrate, and maintain inspection, measuring and test equipment (including test software)..."

I had to address this for my Coordinate Measuring Machine to prove that the mathematical algorithms were correct. I just called the manufacturer and this is apparently standard practice.

I also noticed the the QS9000 PDF files available on http://Elsmar.com/pdf_files/ had a good section on Design (EOP-04-01, Sec 4 "Design Aids and Methods" which says:
"Computer software used for carrying out calculations and other design activities is qualified and approved". It goes on to say the various funky ways of qualifying and approving -- including getting a certificate from the s/w manufacturer.

Doug

Whoa! I blew right past that. Thanks. I have an ISO audit coming up mid-Dec.