Question on Documented Calibration versus ISO 17025 Accredited Calibration

[duff999]

I've been tasked with choosing an option for a certain type of calibration for our lab.

Documented Calibration - service includes standard calibration and documented verification of all data points. A certification data sheet is provide documenting all traceable test equipment and specific data point readings.

Accredited Calibration - calibration with ISO standards (17025) documented verification of all data points and uncertainty data. A full calibration report with the ANAB logo

We are moving toward ISO 13485, wanted to be sure I am working in the right direction. Any advice is appreciated.

 

[Scubabiker03]

We try to use only accredited calibrations but not everything is accredited so sometimes we use non-accredited Cal house to perform certain calibrations. Accreditation is not a requirement but make audits so much easier.

 

[Thee Bouyyy]

As @Scubabiker03 mentioned, not all calibration labs are accredited, so we calibrate our equipment from both accredited and non-accredited calibration labs.

Both have been addressed in our SOP. We are ensuring that non-accredited calibration labs provide us with the traceability certificate that is obligated to be issued by an accredited lab.