Dear colleagues in the Quality field.
I saw this site which I think that is very very interesting and helpfull for all of us.
I work for a company which apply for registering ISO 9001-2000 and API Q1, in the same time.
The problem we have is that our company doesn't has a design department and it's very difficult having one.
As for the ISO we have the possibility to apply exclusions (and to obtain the certification on different modules), I read on the API Q1 standard that design is absolute necessarily. Is it possible to subcontract another company for making the design process for us? Is this considered as we can control the design process as the API requires?
Does anyone knows details about this matter?

Any idea is welcome!

Thank you in advance!

Virgil

Hi Virgil, I think that I can help. You think that you have problems, we have a tri-scope ISO9002:1994, API Q1 and QS9000! You have hit on a real problematic area with Q1 though. In my humble opinion the authors of Q1 did not really understand ISO 4.2 Quality Planning. We manufacture oil and gas pipe 5L and 5CT so I can only discuss from this angle. First you must CLEARLY scope 4.4 design for API only in your quality manual. Since the API specifictions really already denote the product design, we documented and mapped how we controlled the steel grade development, our process development (4.2.3), design verification on trial material (i.e. testing lab), design validation on full production material, documented reviews along the way and finally how chemisty or process changes are controlled. You do these thing anyway I'm sure but if you flowchart it as a "design" process you will be okay. If you need more help with this or want to discuss Q1 contact me at nmasterman@hotmail.com I hope this helps. Good Luck