Calibration by manufacturer

[Ron Rompen]

I am sure that this question has been asked (and answered) several times already, but I wasn't able to find anything with my searches. Sooooooo......here we go again.

I have a piece of measuring equipment supplied by Company A. Company A designs and manufactures the equipment, and ALSO designs and manufactures a reference standard to be used when verifying the measuring equipment. We cannot 'calibrate' the equipment, only verify that it is measuring correctly.

We send the reference standard back to Company A on an annual basis for calibration/certification.

Company A is NOT registered/accreddited to ISO 9001, ISO 17025 or (as far as I can determine) any other standard.

As the designer/manufacturer of the equipment and the reference standard, are they acceptable to perform the annual calibration of the reference standard and the measuring equipment? I am sure that this was mentioned in one of the sanctioned interpretations, but I can't seem to find it anywhere.

Anyone have any input on this?

 

[indubioush]

What type of organization do you work for, Ron, and what regulations are applicable to your company?

 

[Ron Rompen]

What type of organization do you work for, Ron, and what regulations are applicable to your company?

We are an automotive manufacturer - TS16949 registered. No 'special' regulations apply in this case.

 

[dwperron]

On their calibration certificates for the reference standard to they claim traceability to NIST or another national lab?
On the certificate for the reference standard what are they using to calibrate it?
Have you asked the OEM if they can supply measurement traceability for the reference standard?

 

[Scanton]

In section 7.1.5.3.2 of IATF 16949 it 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 7.1.5.3.1 have been met.

There is also a note that says: - Note such evidence may be demonstrated by customer assessment, for example or by customer approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 of national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer approved method of assessment.

So it looks like that as long as the suppliers lab meets the intent of ISO/IEC 17025 and the assessment method for assessing this lab is approved by your customer, that should be enough to satisfy this external calibration requirement.

As always if you know different please shoot me down in flames.