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ISO TS 16949 Clause 7.6.3.2 - Requirements for External Laboratories

qusys

Trusted Information Resource
#1
Is this requirement referred to only the gauge/tools that are mentioned in control plan?
I mean if an organization uses some tools ( such as caliper, multimeter etc...) that are not inserted in the control plan , is an ISO TS organization obliged to send out to ISO 17025 accredited external labs in the case it does not have any internal lab for calibration and it wants to have them calibrated anyway?:bigwave:
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: ISO TS 16949 Clause 7.6.3.2 - Requirements for External Labs

If I was looking at this circumstance I would expect the tools are used in a process that is not listed in the certification scope.

The requirement is not to send to a 17025 accredited lab, but to use a lab with a defined scope that includes the capability to perform the required test or calibration, and is either 17025 accredited or is acceptable to the customer without 17025 accreditation. In other words, using non-accredited labs is permitted so long as the customer approves. It follows that some record of the approval should be available.
 

qusys

Trusted Information Resource
#3
Re: ISO TS 16949 Clause 7.6.3.2 - Requirements for External Labs

If I was looking at this circumstance I would expect the tools are used in a process that is not listed in the certification scope.

The requirement is not to send to a 17025 accredited lab, but to use a lab with a defined scope that includes the capability to perform the required test or calibration, and is either 17025 accredited or is acceptable to the customer without 17025 accreditation. In other words, using non-accredited labs is permitted so long as the customer approves. It follows that some record of the approval should be available.
So, the fact that they are not mentioned in the control plan is not influent ?
Is a waiver of the customer enough or is it need an assessment of second part on not accredited ISO 17025 labs?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Re: ISO TS 16949 Clause 7.6.3.2 - Requirements for External Labs

The reason I made reference to certification scope is an expectation that AIAG and the automotive customers it serves is trying to avoid dual management systems in the same organization: one for automotive, the other for non-automotive.

But I need to point out that I am operating with a limited set of information. I have done a Google search for AIAG guidance on specifics like this one, and found nothing I can feel sure gives you the certainty you are asking for. Until I finish AIAG's course and exam and qualified for CB Lead Auditor under the the TS 16949 standard my insights are limited to that of internal auditor.

I would love to see what responses others offer. :cfingers:
 

Howard Atkins

Forum Administrator
Staff member
Admin
#5
Re: ISO TS 16949 Clause 7.6.3.2 - Requirements for External Labs

The control plan requirement only applies to MSA clause 7.6.1

If you use an external lab for inspection, test or calibration services , this includes functional and material tests not only calibration it must be an accredited laboratory of approval from the customer.
If for example you outsource a salt test then this must be in a ISO 17025 which has in its scope- or at a lab approved by your customer in advance,
You need always to request the scope of any lab that you use to ensure that the test that the work that you order is within its scope
 

morteza

Trusted Information Resource
#6
Re: ISO TS 16949 Clause 7.6.3.2 - Requirements for External Labs

Hi qusys,
Clause 7.6.3.2 also applies for calibration of any gauge used for providing valid results (see 7.6), whether the gauge included in CP (such as a gauge used for checking the part by operator) or not (such as a micrometer which is used by a product auditor).
So, the organization shall use a lab which has been accredited to ISO/IEC 17025 or approved by customer.
 

qusys

Trusted Information Resource
#7
Re: ISO TS 16949 Clause 7.6.3.2 - Requirements for External Labs

Hi qusys,
Clause 7.6.3.2 also applies for calibration of any gauge used for providing valid results (see 7.6), whether the gauge included in CP (such as a gauge used for checking the part by operator) or not (such as a micrometer which is used by a product auditor).
So, the organization shall use a lab which has been accredited to ISO/IEC 17025 or approved by customer.
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?:bigwave:
 

qusys

Trusted Information Resource
#8
Re: ISO TS 16949 Clause 7.6.3.2 - Requirements for External Labs

The reason I made reference to certification scope is an expectation that AIAG and the automotive customers it serves is trying to avoid dual management systems in the same organization: one for automotive, the other for non-automotive.

But I need to point out that I am operating with a limited set of information. I have done a Google search for AIAG guidance on specifics like this one, and found nothing I can feel sure gives you the certainty you are asking for. Until I finish AIAG's course and exam and qualified for CB Lead Auditor under the the TS 16949 standard my insights are limited to that of internal auditor.

I would love to see what responses others offer. :cfingers:
The clause of ISO TS is very controversial, expecially in the case the calibration is only assured by the manufacturer of the gauge. :bigwave:
 

morteza

Trusted Information Resource
#9
Re: ISO TS 16949 Clause 7.6.3.2 - Requirements for External Labs

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?:bigwave:
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.
 
V

vanputten

#10
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.
 
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