Calibration Certification Qualification vs. Verification by Uncertified Staff

We recently underwent an ISO 13485 inspection. Some of our instruments are calibrated in-house by our production staff according to the manufacturer’s instructions. The auditor mentioned that this should not be called calibration because the production staff are not certified. This should rather be called qualification or verification.
I feel that if they are doing calibration we should call it calibration.

Would appreciate any comments.
Thanks

Re: Calibration Certification

Gazielmd said:

We recently underwent an ISO 13485 inspection. Some of our instruments are calibrated in-house by our production staff according to the manufacturer’s instructions. The auditor mentioned that this should not be called calibration because the production staff are not certified. This should rather be called qualification or verification.
I feel that if they are doing calibration we should call it calibration.
Would appreciate any comments.
Thanks

Click to expand...

Gazielmd,

Are your in house calibrations traceable to national measurement standards? If not what standard is used and is this standard accepted by your industry and by your customers?

Do you have evidence of competence (against the abilities, skills and knowledge you have specified sufficient to do the job) to calibrate these instruments?

Or did the production staff just follow the manufacturer's instruction (that possibly misuses the term calibration) to verify the calibration status of the instruments against a standard that is calibrated?

Your auditor may be trying to help you by not claiming a verification as a calibration.

Did you also call an audit an "ISO 13485 inspection"?

John

Thanks for your answer John.
The audit was a format external audit by the National Standards Institute.
However you have given me a lot of "food for thought" and I will need to check more thoroughly what is being done.
Thank you.
Mandy

Thread moved to obtain more visibility from Metrology professionals.

Gazielmd, calibration has specific requirements to be met.

First is traceability. The measurements must be traceable through an unbroken chain of comparisons, through National or international standards, to SI Units. There are some measurements not traceable to SI, and those are addressed by traceability to National or international standards.

Second is uncertainty. Each step in the traceability chain must have stated uncertainties. The uncertainties must include both Type A (aka Random) and Type B (aka Systemic), and are typically expressed at approximately the 95% confidence level.

Absent either of those two, it is not calibration.

Now, for the certification of your personnel, the obvious question is whether Israel has such a certification. If not, ASQ administers the Certified Calibration Technician (CCT) program. CCT is international and developed by metrology professionals. However, if Israel has such a program it may be a requirement to use that. You will have to check the regulations, or have the assessor show you.

Absent such requirements in a regulatory manner, simply stating it is not calibration because personnel are not certified may be difficult to support.

Beyond what I have typed here, I agree with John.

Hope this helps.

Excellent answers. I'd add that, even if you changed the terminology from calibration, to verification, any auditor who comes in and makes such a statement - and possibly writes a non-conformity - is incorrect! I'd encourage you to feedback to NSI the results of your investigation to ensure that this particular auditor is advised NOT to make the same mistake in the future!

Reminds me of all the times the AS9100 auditor would come to the lab and they would say, "but we're not a lab, we're a facility . . . ."