Calibration question

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#1
We use a local ISO 17025 calibration company. One of our items is a calibrated hot bath and sensor. We sent it to this company but they botched the calibration job and it was not providing accurate numbers compared to several other calibrated items.

During a management meeting, we decided to send the item to the OEM for repair and testing, which they did and returned the item in proper working condition. The issue we might find is that although the OEM is on our ASL, they do not have ISO 17025 certification. Is that an issue?
 
Last edited:
Elsmar Forum Sponsor
#2
It is only an issue if
(A) your quality system requires that calibration suppliers have a ISO 17025 certification
or
(B) The OEM is only listed as an equipment provider and not a calibration provider on the ASL.
or
(C) Your particular medical device has a standard document stating that calibration providers must have ISO 17025 certification.
 

Funboi

Posts Moderated
#3
Guys, for clarity, is the first lab claiming certification or accreditation - big difference, which could be why they screwed up!

One thing all Quality Systems need is a deviation process which allows you to deal with such situations…
 
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