What is the real purpose of a Certificate of Conformance "C of C"?

[Jim Wynne]

I have a question on this topic. If an organization is registered to a standard such as ISO 9001:2000 or similar, why on earth would the customer even/want need a CofC? Doesn't the registration trump any CofC? (provided that there are NO special customer requirements.)

Assuming that it's a standard CoC we're talking about, and not a cert of analysis or test (providing actual analysis/test data), so long as there's a purchase order (contract) that specifies the requirements, it doesn't matter whether the supplier is ISO-registered or not; the cert is still worthless.

 

[MIREGMGR]

I have a question on this topic. If an organization is registered to a standard such as ISO 9001:2000 or similar, why on earth would the customer even/want need a CofC? Doesn't the registration trump any CofC? (provided that there are NO special customer requirements.)

From the perspective of a primarily-FDA-regulated medical device maker, as far as I know the FDA's efforts toward harmonization have not progressed to the point where they consider ISO13485 registration of a device maker and 13485 or 9001 registration of one of their suppliers, in the absence of more specific evidence, to establish conformance with 21 CFR 820.50 Purchasing Controls.

Supplier provision of "certs", by itself, isn't sufficient proof of that conformance either, but in my experience it's a substantial step in that direction.

Note that this perspective is in regard to FDA conformance only.

 

[Crusader]

Assuming that it's a standard CoC we're talking about, and not a cert of analysis or test (providing actual analysis/test data), so long as there's a purchase order (contract) that specifies the requirements, it doesn't matter whether the supplier is ISO-registered or not; the cert is still worthless.

Thanks! I tried to explain that to a customer awhile back but they got upset and refused to believe that the CofC was worthless. They insisted that I provide one.

 

[Jim Wynne]

Thanks! I tried to explain that to a customer awhile back but they got upset and refused to believe that the CofC was worthless. They insisted that I provide one.

Well, it's legally worthless. If the customer insists, it has some value to them even if the value is the result of ignorance or delusion. If I refuse to leave my house until the giant ogre is out of sight, it doesn't matter if there's really no ogre--I ain't leaving 'til he's gone.

 

[John Nabors - 2009]

Our two biggest customers (together responsible for about 75% of the product we ship) are very large aerospace contractors. One of them, (whose name I shan't mention because that could come back to haunt me) could require any one of 15 different recipes of sets of certs, sometimes involving literally pounds of paperwork, not only depending on which facility we are shipping to, but even down to different programs within the same building. Is this time intensive? Yesirree, Bob. Maddening at times? Yup. Is the product any better as a result? Nope.

But the customers are always right even when they're wrong.

 

[Crusader]

So why do we spend $$$$$$$ to get registered if the customer doesn't see it as "good enough" /better than any cert?

 

[John Nabors - 2009]

Crusader-

Because the customers are always right even when they are wrong.

 

[bobdoering]

If it wasn't for customers complicating the issue by demanding the death of innocent trees, one could put in the purchase order that simply shipping the product is considered evidence that the product has met all of the requirements. Hmmm....novel idea, huh?

 

[Jim Wynne]

Our two biggest customers (together responsible for about 75% of the product we ship) are very large aerospace contractors. One of them, (whose name I shan't mention because that could come back to haunt me) could require any one of 15 different recipes of sets of certs, sometimes involving literally pounds of paperwork, not only depending on which facility we are shipping to, but even down to different programs within the same building. Is this time intensive? Yesirree, Bob. Maddening at times? Yup. Is the product any better as a result? Nope.

But the customers are always right even when they're wrong.

I think aerospace, medical, and other regulated industries are different from the more mundane types of businesses/customers that require "certs." Part of the reason is government bureaucracy, and another part is (probably) a genuine need for paper trails and details.

 

[bobdoering]

I think aerospace, medical, and other regulated industries are different from the more mundane types of businesses/customers that require "certs." Part of the reason is government bureaucracy, and another part is (probably) a genuine need for paper trails and details.

True - they have always had more of a need for paper trails for the necessity of extracting blame. Earlier aerospace and medical quality systems were based more on that than process control, etc. Evidence, signatures, no white out, etc. - nothing that influences the product itself. The only thing one might say is that the paperwork is a paid part of the product, so it had better be there to get paid. But, there is a level of this that becomes so superficial that there is little to gain from the overhead required to maintain it. But, nobody is going to poke that hornets nest...