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Hi, one of our suppliers performs calibrations on all of their measuring devices, however, they do not specify any tolerance requirements. In one case, they calibrated a temperature controller and the "as-found" temperature was 20% off from the setpoint. It was adjusted back to the set point but there was no impact assessment or out-of-tolerance evaluation done since it was not even considered out-of-tolerance!
Is it a requirement of the standard (ISO13485) that tolerances be defined? If so, under what clause would it fall?
Thanks for your help!
Is it a requirement of the standard (ISO13485) that tolerances be defined? If so, under what clause would it fall?
Thanks for your help!