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Producing IATF 16949 compliant calibration certificates

M

mlee97

#1
Dear Experts,

My company produces fine electronic torque wrenches where we produce a calibration certification based on testing at the assembly line. We hire a nationally recognized, 17025 certified, gage calibration company to supply, maintain, and calibrate the line gages. We sell to the automotive assembly industry who has started questioning our certs. They have discovered that our laboratory is not 17025 certified and this is causing us lots of grief, however, I contend that our laboratory has nothing to do with the calibration certification as they never touch or make decisions on those gages. That is out-sourced to the accredited lab. Sadly our certificate does not explain this relationship that our calibration certification relies on the external lab's accreditation and traceability path.

I need to correct this. How do I wordsmith this to pass an auditors eye? What is the explicit requirement for the certification in IATF 16949?
 
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Sebastian

Trusted Information Resource
#2
I am not an expert, but I know what I am talking about.
I understand your customers are IATF 16949 certified, your external/commercial laboratory is 17025 certified while your internal laboratory is not. But ... who are you? I mean certified management system. Do you have any?
 

Eddie74

Starting to get Involved
#3
The in house gage calibration certification issued to your customer should reference the calibration certification number that is issued by the 17025 accredited lab. The 17025 lab certification should be readily available for review by the customer. This will provide the traceable certification route necessary to a NIST traceable master.
My opinion.
 
M

mlee97

#5
That sounds good. So you think if I can get the external lab to set up the machines to provide their Certification numbers we could get by?
I don't have a copy of the IATF anymore. What applies here?
 
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Eddie74

Starting to get Involved
#6
? The lab should be supplying some form of calibration certification for each "machine". Each machine should have a Serial Number. The lab certification number and the "machine" serial number should cross reference each on the lab certification report. If not, there is no traceability of calibration by a 17025 accredited lab.
Also the QMS procedures should define this process.
 

Sebastian

Trusted Information Resource
#7
What is a scope of your certification and why 17025 is referred here? You are manufacturer and element of product you supply are documents which are evidence of meeting requirements stated in customer's order.
17025 can be applicable to suppliers of calibration, measurement, test services and you are not one of them. What is a point? Order states you are supplier of periodical calibration services?
 
M

mlee97

#8
? The lab should be supplying some form of calibration certification for each "machine". Each machine should have a Serial Number. The lab certification number and the "machine" serial number should cross reference each on the lab certification report. If not, there is no traceability of calibration by a 17025 accredited lab.
Also the QMS procedures should define this process.
Yes, the Machine Serial numbers and Cal dates should be already one the cert. (I actually haven't seen one yet. I need to get out on the floor and get one I guess.)

Yes our QMS document should define the process, I need to check and review it as well. But I'll likely have to change it to address this issue.
 

Golfman25

Trusted Information Resource
#9
You are going to have a real problem here. In general outside calibration labs must be 17025 certified -- so most customer are looking for the cert with that designation to file away and "show the auditor" when it comes up. Simple.

Your customers can have their own independent calibration done.

The second option is it allows an exception if the external lab is acceptable to the customer. So your customer's customer would have to sign off. Probably more likely to get an act thru Congress. :)

Your "out" is in the second part of 7.1.5.3.2 which says: "Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met." 7.1.5.3.1 is the requirements for internal labs -- scope and such. You'll need to figure out how to get yourself into that exception. Good luck.
 
M

mlee97

#10
You are going to have a real problem here. In general outside calibration labs must be 17025 certified -- so most customer are looking for the cert with that designation to file away and "show the auditor" when it comes up. Simple.

..

Your "out" is in the second part of 7.1.5.3.2 which says: "Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met." 7.1.5.3.1 is the requirements for internal labs -- scope and such. You'll need to figure out how to get yourself into that exception. Good luck.
The outside calibrator is the manufacturer of the test unit and they are certified to the 17025 lab standard. Their software actually produces page two and three of the certificate package, but page one, the actual cert, needs to be dressed up to Name the calibration lab and place the serials and cal data as I see it.

But other than that we should be OK, right?
 
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