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New IATF Sanctioned Interpretations April 2021

#1
How to understand note in new IATF Sanctioned Interpretations #10:
Note: integrated self-calibration of measurement equipment, including use of proprietary software, does not meet the requirements of calibration

We have some specific devices and only manufacturer can make calibration. No exteral laboratory can do it.
 
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Ashland78

Starting to get Involved
#2
As long as your customer is aware that you are self calibrating (using ISO 17025 compliant procedure) or using OEM...You will be ok.

When we have no other choice but OEM we show evidence that we tried 3 accredited calibration providers, we save that evidence in gage file. This has worked for many years as we have evidence.
 

Miner

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Admin
#3
I don't think the intent of this note was written to preclude the use of the OEM to calibrate the machine. I have seen machines that purport to automatically calibrate themselves, usually through the software. However, this is problematic for several reasons: 1) the standard used is either not traceable, or is never verified once the machine has been purchased; 2) self calibration only addresses one subsystem within the machine and does not address the entire measurement system; 3) it is usually not conducted under controlled conditions. There are probably other reasons, but these are the ones that I have seen in practice.
 

Sebastian

Trusted Information Resource
#4
Inspection machine can have "button", which when pressed initiate procedure of self-calibration and after display says "Ok", "Calibrated", "Start measurement". No, there is required calibration procedure, traceable calibration standard, report with measurement reading achieved during calibration, etc.

You can still use equipment manufacturer calibration services, but first you have to evaluate (audit) them to check whether they meet requirements of requirement of 7.1.5.3.1 intended for internal laboratories.
Do they know these requirements?
Who in your company is competent to evaluate them?
Do they agree to be evaluated?

Now, you can't simply send and e-mail to your customer, stating that there is some equipment and asking whether he agrees, that it is calibrated by it's manufacturer.
 
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#5
Inspection machine can have "button", which when pressed initiate procedure of self-calibration and after display says "Ok", "Calibrated", "Start measurement". No, there is required calibration procedure, traceable calibration standard, report with measurement reading achieved during calibration, etc.

You can still use equipment manufacturer calibration services, but first you have to evaluate (audit) them to check whether they meet requirements of requirement of 7.1.5.3.1 intended for internal laboratories.
Do they know these requirements?
Who in your company is competent to evaluate them?
Do they agree to be evaluated?

Now, you can't simply send and e-mail to your customer, stating that there is some equipment and asking whether he agrees, that it is calibrated by it's manufacturer.

Thank you , now it's clear for me
 
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