ISO 9001 - 8.4.1 Evaluate All Suppliers?

Dan M

Involved In Discussions
#1
Hi, my interpretation of 8.4.1 was that it is required for "products and services from external providers are intended for incorporation into the organization’s own products and services." So therefore we control and evaluate our raw material suppliers. Received an external audit minor NC for not evaluating other types of suppliers (lab supplies, contractors performing maintenance, etc.). Is this right?
 
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RoxaneB

Super Moderator
Super Moderator
#3
Like @Jim Wynne , I'm curious about the exact wording of the finding.

Based on what you have provided, there is no requirement to my knowledge that requires you to evaluate all suppliers, however, nothing was said if you use other external organizations where their absence (or failure to perform) could adversely impact your organization's ability to meet customer requirements.

Example : I have a background in steel-making. Our raw material suppliers were critical as were some suppliers of components key to our process (i.e., $$$ items with long lead time where if we ran out, we'd be in trouble in meeting delivery dates). We sub-contracted out some maintenance functions - their failure to complete their tasks on time and properly could impact our ability to meet customer requirements, so they were on our list. The labs were key suppliers because they calibrated our equipment that allowed us to say our steel met the desired properties. Our delivery companies were on the list because they could impact if product arrived on time and in spect.

8.4.1 allows your organization to determine the controls to be applied to suppliers. - without knowing the exact wording of the finding, I'm leaning towards it being more about having an expanded and robust supplier evaluation program for critical suppliers.
 

BradM

Staff member
Admin
#4
I agree with Howard Johnson and Samuel Johnson (sorry... Blazing saddles reference).

Look at it this way.... I needed some hardware to repair a door to a lab. Does Home Depot need to be evaluated?
Toilet paper provider? Company that repairs and fills the copier up with paper?

Maintenance... a company is called to repair a non-validated oven. A verification performance check/ calibration is performed pre and post of the repair. Do they need to be on the list? One can go insane (and waste sooo much resources) evaluating each and every vendor. It needs to be based on some level of criticality. But all this may be academic depending on the actual observation.
 

Randy

Super Moderator
#5
Pretty dicey, what if the supplier is Uline, Grainger or even eBay? Kinda tough to do them. Could be done, but kinda tough.
 

gpainter

Quite Involved in Discussions
#6
Depends what your procedures say. When I was in ISO QMS. We said all new suppliers will be evaluated and that key suppliers would be on a yearly evaluation based on our criterion. Suppliers that had no direct impact on quality did not need evaluation. Never had an issue. Sounds more like an OFI to me. Did they find anything in your CARS that may have lead them to this?
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#8
We classify our suppliers as either distributors or subcontractors. Distributors don't need an initial evaluation, but we do add them to the approved supplier list and monitor their order accuracy and delivery performance. Subcontractors go through an initial evaluation, the team decides if further evaluation is needed for any reason, and then they get put on our approved supplier list and we monitor their quality and delivery performance.
 

Mark Meer

Trusted Information Resource
#9
Work backwards: What is the impact of a potential non-conformance of the product/service? If it is significant, then it'd be prudent for the supplier to be subjected to some sort of evaluation.

Think of it this way: if your next-door neighbour offered to perform calibrations or maintenance, I'd presume that your system has some sort of evaluation to demonstrate they are actually qualified (capable of reliably meeting your requirements), before accepting them as suppliers, no?
 

Ninja

Looking for Reality
Trusted Information Resource
#10
FWIW, we did them all...ish...but stated that "non-key" suppliers such as Home Depot, Uline, etc. were considered passable by the fact that we chose to buy from them and would be reevaluated if a problem arose.
Non-key suppliers were 'evaluated' per shipment according to receiving protocols (did they ship what we ordered?)...other suppliers, including materials going into product, were evaluated 'periodically'.

Our approved supplier list did not list OfficeMax...but did reference "other miscellaneous and dunnage suppliers per ##-####" (doc number).

Never had a finding on that.
 
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