ISO TS 16949 Clause 7.6.3.2 - Requirements for External Laboratories

[morteza]

In Reply to Parent Post by qusys

Approved by customer, how? With a second part audit or its audit on the the supplier?
In which phase could be the approval or the waiver from the customer could happen?

Hi qusys,
All OEM usually provide a list of approved labs in their website or via a formal letter, for their suppliers.
As mentioned in NOTE 1 under clause 7.6.3.2, approval of labs by customer may be obtained by customer or its representative(s) assessment to check whether the laboratory meets the intent of ISO/IEC 17025 or not.
For calibration, many OEM usually approve labs which have been accredited to ISO/IEC 17025. But for test or inspection, they also introduce labs which only approved by them.
If you use a lab which has not been accredited to ISO/IEC 17025 or has not been approved by customer, you should inform the customer and arrange for lab visit by customer, and , if it is possible, to get a letter of approval from customer.

[vanputten]

My understanding is that 7.6 and its sub-clauses generally apply to "equipment needed to provide evidence of conformity of product to determined requirements." This needed equipment may or may not be listed on a control plan.

The type of evidence needed that the external lab is acceptable to the customer(s) is not specified so it is up to the organization to determine if they have the evidence. Evidence could be written approval from the customer based on the organization's audit of the lab or the customer's audit of the lab. It could be evidence of approval from the customer based on a justification letter sent to the customer. It could be that the lab is listed on a customer's list of approved inspection, measuring or test service providers. I am sure there are other forms of evidence that could be acceptable to show the customer's approval.