We recently received out ISOTECH TTI-10 back from the cal house and it was "received OOC' we opened a CAPA. This device is a temperature measuring device. We ran some internal tests. We set it against an oven we have that was calibrated last month. It should be noted that my companies sole product is a temperature measuring patch that is verified and validated.
For the test we put the over to 30'C and placed the TTI-10 and 20 of our own devices in the oven. The result was that all of our patches agreed with the oven but the TTI-10 was 0.400'C over the set point.
I havean ISO 13485 audit next week. We have sent the TTI-10 to ISOTECH with our complaint for them to review this issue.
How should I defend this to the auditor that I believe the calibration house was wrong?
TLDR: We sent a device out for cal and the cal house said it was received OOC. We sell validated devices that also do the same thing the tool does and it disagrees.
For the test we put the over to 30'C and placed the TTI-10 and 20 of our own devices in the oven. The result was that all of our patches agreed with the oven but the TTI-10 was 0.400'C over the set point.
I havean ISO 13485 audit next week. We have sent the TTI-10 to ISOTECH with our complaint for them to review this issue.
How should I defend this to the auditor that I believe the calibration house was wrong?
TLDR: We sent a device out for cal and the cal house said it was received OOC. We sell validated devices that also do the same thing the tool does and it disagrees.