Applicability of 7.3 Design to Assembly Operations

[florin pirvulescu]

to be or not to be design and development

I'm QM at a small company dealing with electronics and automation. Including asambling of computers. We face a question regarding applying the requirement 7.3 Design and develpoment in assembling the computers. In our opinion we don't need to consider a design for every assembled central unit, as we just put together parts and components resulting a sistem already designed by brand names in the world. A design project would mean records for every stage that ISO 9001 requires. We try to keep things as simple as possible. Of course we have a design procedure for cases when we consider or our client ask for (eg. IT & C networks).
All that worry is against the requirement of Certification Body which has a different oppinion.
What do you think Q-falks? Is it or isn't necesary? And why?

 

[Marc]

I'm QM at a small company dealing with electronics and automation. Including asambling of computers. We face a question regarding applying the requirement 7.3 Design and develpoment in assembling the computers. In our opinion we don't need to consider a design for every assembled central unit, as we just put together parts and components resulting a sistem already designed by brand names in the world. A design project would mean records for every stage that ISO 9001 requires. We try to keep things as simple as possible. Of course we have a design procedure for cases when we consider or our client ask for (eg. IT & C networks).
All that worry is against the requirement of Certification Body which has a different oppinion.
What do you think Q-falks? Is it or isn't necesary? And why?

I assume you buy components and sub-assemblies (LRUs) and put together a 'box'. Design is probably applicable to you only in the sense of how you design your assembly processes (7.1). Traditionally process design was not considered Design in the traditional sense / use.

How do you determine customer requirements and the degree to which they go? Does your customer define the enclosure? The basic frame compenents and sub-assemblies attach to?

It sounds to me like 7.3 would not be applicable.

 

[florin pirvulescu]

It sounds to me like 7.3 would not be applicable.

It sounds to the same. We have to persuade our certification body. If we don't succede, we will have a QMS for auditors not for us. But I guess we will be neither the first nor the last in that situation. A situation in which the spirit of ISO dies little by little.
Thank you for you quick reply.
Florin Pirvulescu