Hi!

A building construction organization just purchases Design and Development, even though they make a nice follow up of this process made by a supplier.

They even have an internal QMS Procedure about this item. Of course this procedure just explains the way they control their design supplier.
In fact they don’t make any design activities, they just purchase them...

Can they be registered ISO 9001:2000, without excluding requirement 7.3?
In advance I leave here already my opinion – NO!
Any different opinion?

Thanks
AV

Can they be registered ISO 9001:2000, without excluding requirement 7.3? Antonio, I think you meant to ask: Can they be registered to ISO 9001:2000, CLAIMING exclusion to 7.3? "without excluding" means that they take no exception to the requirement.

The answer is very simple. As long as the CB they contract with know what they are doing, they would not accept the exclusion.

Just because an organization outsources a process, it does not mean that they can exclude it from their QMS. Outsourcing is no justifiable basis for exclusion. It is still incumbent on the organization to demonstrate how the outsourced process satisfies the applicable requirements of the standard.

Sidney,

First of all, thanks for you kind explanation.
Perhaps I didn’t explain the correct situation.

This organization wants to get registered considering they have Design & development, even though they just outsource those activities.
In fact what they have are just the outputs of a Design Process made by other organization.
They even have that organization in their suppliers list.

In my opinion for this organization to claim having a design process according to ISO 9001:2000, they should have to do a lot more than just inspect the incoming output of others Design process.
Of course I could see it other way. If the Design Planning (7.3.1) is done is a way in which is referred the current situation of a complete outsourced but controlled design process, I think it will be possible to consider registration with 7.3 included.

AV :)

To answer this question, one needs to have an understanding of 'industry practices'. In Malaysia, we follow the British Practice where both the architectural and engineering designs need to be certified by registered professionals in the respective field. These professionals can be in-house or contracted but the individuals who signed on the approved plans will be ultimately responsible for their designs.

Based on the above, it makes no difference whether the designs are done in-house or by third parties. The contractor who purchase the design from others or do it in-house would have given their inputs for design, verify that the design meets their requirements and finally approved and accept the design. The technical part including verification and validation of design is the responsibility of the respective architect and engineer (whether in house or outsourced). If the contractor himself is a qualified engineer or architect and he signs on these drawings, he do so in his capacity as a registered professional and not as the contractor.

Apart from these, such contractors have additional responsibilities from the supervision and implementation point of view. My answer is they are different from the ordinary 'build only' contractor and therefore qualify to include D&D in their scope of certification.

Incidentally, all contractors are responsible for the design of temporary works which they often subcontract to specialized companies (scaffold, shoring, underground works, etc). In fact I find it unacceptable for contractors to claim they don't do design work.

In my opinion for this organization to claim having a design process according to ISO 9001:2000, they should have to do a lot more than just inspect the incoming output of others Design process.I agree that they need to do more than simply "inspect" the design package, but be aware that many organizations that outsource 108%:tg: of their manufacturing processes are ISO 9001 certified and the fact that all of the production is done elsewhere is not transparent to the user of the certificate. Until the IAF enforces a rule that requires the identification of the outsourced processes in the certificate, transparency of issues such as this will be questionable.