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API Q1 7.4.1.2 Supplier Selection Supplemental

J

Jac3LLC

#1
Two questions.

Im getting hung up on 7.4-1-2 (d).
"Verification by the organization the the supplier's QMS conforms to an internationally recognized QMS standard / Technical specification."

We do business with several mom and pop machine shops that do their own inspection and provide First Article evidence with everything they produce.
We subsequently inspect their products at Receiving Inspection.
I dont think its likely that any of these businesses have any intention of ever becoming ISO registered.
Does the standard explicitly mean that they must be ANSI or ISO registed?

Second question.
How do we handle purchasing through a distributor that isnt registered, but all of the products they sell are produced by ISO registered manufacturers?

Thanks
 
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#2
Two questions.

Im getting hung up on 7.4-1-2 (d).
"Verification by the organization the the supplier's QMS conforms to an internationally recognized QMS standard / Technical specification."

We do business with several mom and pop machine shops that do their own inspection and provide First Article evidence with everything they produce.
We subsequently inspect their products at Receiving Inspection.
I dont think its likely that any of these businesses have any intention of ever becoming ISO registered.
Does the standard explicitly mean that they must be ANSI or ISO registed?

Second question.
How do we handle purchasing through a distributor that isnt registered, but all of the products they sell are produced by ISO registered manufacturers?

Thanks
The paragraph reads:
Criteria for the selection, evaluation and re-evaluation of suppliers shall include one or more of the following:
a) inspection of supplier's final product by the organization at supplier's facility;
b) inspection of supplier's final product by the organization upon delivery;
c) surveillance of supplier's conformance to the organization's purchasing requirements;
d) verification by the organization that the supplier's quality management system conforms to an internationally recognized quality management system standard/technical specification.
Please pay close attention to the words "one or more". So, if you perform a receiving inspection of the shipped product, you comply with b) above and would satisfy the minimum requirements of the paragraph in question. Also, according to d) you could do your own assessment of the supplier's QMS against a standard and not necessarily require the small supplier to be certified.
 
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