7.3 Design and development - Implementing ISO 9001 in the chemicals industry

I am looking for help or sources of information on implementing ISO 9001 in the chemicals industry. So far our manufacturing units are registered to ISO 9002, we are now looking to register our R&D centre, which will mean we must cover the Design and development section for the first time. Can any one provide some pointers how this can be done in this sector?

[Greg Mack]

Hi Nicola,

Why don't you just document what they do in the R&D Team and then see where you do not meet the intent of the Standard. Then it will be easier to see where you need to improve your processes based on 9001.

[HFowler]

I came from a metalworking background into an electronics and computer software environment. Our company has been doing business for over (20) years, but I am implementing their first documented quality management system.

I am looking for some sample "Design Review" forms that would be specific to the development of software and electronics. I am having difficulty explaining how to document Design and Development Reviews, Verification, Validation and Control of Changes. I think we need some standardization rather than each engineering group doing their own thing.

Any help is greatly appreciated.

Hank Fowler

[E Wall]

Just wanted to bump this up.

Hank, sorry I don't have an answer for you but will give it some thought and let you know what I come up with.

[HFowler]

Thanks Eileen, I really could use some good information in this area.

Are you still enjoying snow? We have 4-6 inches, but it was as hard as ice at 18 degrees this morning.