QS-9000 Internal Laboratory Requirements - Guide 17025 certified or equivalent

P
#1
Hello,
I am an internal auditor and I have been tasked with bringing our labs on site up to speed to the QS-9000 requirements. The internal qualifications are not a problem, the problems lie in accreditation of labs we use in addition to our own. If any one could help answer the following questions or direct me to where I could find additional information I would be very grateful.
If I have this correct, QS-9000 requires that all external labs used for analysis and calibration must be Guide 17025 certified or equivalent.
What other National Equivalents?
What can a company do if the external labs they are currently using are not 17025 certified and:
Is the only lab that can perform the required analysis
Is the closest lab to the company and provides the best turnaround time to meet internal/external customer needs
Is the most cost effective choice for the company
What is the protocol for non-certified labs?
Can we perform an audit on their quality systems and approve them for use?
If so, is there a guideline/checklist that we can use that will satisfied QS9000 requirements?
Can we request our customers to waive the accreditation requirement?
Does this include everything sent outside the company or can we define what is required to be sent to accredited labs?
 
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D

Dan Larsen

#2
To answer your questions…

Guide 25 or national equivalent: If you're in the states, an equivalent would be ANSI Z 540. But be cautious. I think most accreditation bodies accredit to the ISO Guide or standard (17025).

If they aren't accredited: Find one that is. Most registrars are writing the use of a non-accredited lab as a major.

If it's the only lab that can perform the test: This is a tough one. I think I'd be prepared to provide documentation to support my search for an accredited lab. You might be able to fight it.

Is the closest lab/best turnaround lab: Too bad. If the lab you're using is not accredited and others are, I think you're stuck.

Is the most cost effective choice: See above.

Can you perform an audit: I don't think so, unless you've been certified as an "OEM customer approved second party".

Is there a checklist: Yes there is…see the A2LA website. It's readily available, but based on the answer for the last concern, I think its academic.

Requesting a waiver: This is probably your best bet. Customer requirements always override the standard. Make sure it's written evidence and clearly states that you don't have to comply to the specific sections in the standard.

Does this include everything: I'd say yes, unless you have an explicit wavier from the customer.

These are my opinions based on what I'm hearing in the industry. Good luck to you.
 
D

Dan Larsen

#3
On a side note here...

Does anyone know if the AIAG has been pushed on a restraint of trade issue? PAS raises an interesting point. If I have a supplier that is providing quality service on a timely basis (and I can prove it!) at a lower cost than the supplier the standard says I have to use, red flags start coming up in my mind. This is especially true if my customer is demanding I control (even reduce) my price to them (therefore, reduce my cost to provide the service).

Comments?
 
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