Scope Definition - Scope of ISO 9001 Registration

[harry]

You was the one who stated I don't agree that we are splitting hairs. As I said already, it is totally acceptable for an organization to limit the scope of certification. Obviously, the certificate has to be truthful to what exactly is being certified. In the OP's case, if they exclude the product development processes from the QMS and go for certification, an educated customer should ask: Why is design not covered under the certification? This organization is design responsible, after all. Irrespective if the organization considers the Design function a "supplier", even outsourced processes are responsibility of the organization.

Remember, as well, that ISO 9001 4.2.2 requires the quality manual to identify and justify exclusions and references section 1.2. ANAB accredited CB's are MANDATED to ensure that scopes of certification and quality manual exclusions are appropriately documented.

Just like in the old days of ISO 9001 and 9002, when CB's would certify design-responsible organizations to 9002, games are still being played today. And the only way to put an end to this is NOT more policing by accreditation bodies, but better educated users of management system certificates. Knowledgeable customers that would keep their suppliers and suppliers CB's accountable to the spirit of the accredited certification process.

I have to take my hat off for Sidney. I've noticed that he can see things further and at the 'users' point rather than trying to interpret the standard like a 'lawyer' and way away from market or business practices.

From my perspective as a user, I've learned the hard way about the importance of a strong design and development process (many loosely termed as R&D).

Whether you design your own products or sourced parts to incorporate into your products, Quality starts from D&D - no two ways about it. Profitability too and I remember the 1-10-100 rule too well. A defect that costs $1 to rectify at the design stage will cost $10 to rectify if detected at the production stage and it will burn a $100 hole in your pocket if you allow it to get out of your factory. This is not a myth but truth that I had seen many times.

If I need to choose between certification for design & development alone or the usual manufacturing without D&D, I will choose the former.

Ideally, it should be the complete process starting from D&D.

 

[Marc]

The key is the elimination of "weasel words". Years ago many places that were service companies got by with design 'exclusions'. Today they can't claim that exclusion. In a way, with respect to design, the definition has changed. As Sidney says, remember ISO 9002 and ISO 9003? R&D is wedded to D&D.