Charles Wathen
Involved - Posts
I work for a company that has it's own internal calibration lab. We calibrate about 88% of the in house equipment, with the rest going out to calibration vendors.
During an external audit, the auditor asked if we are accredited to ISO17025. Our answer was no we are not. Here is what we submitted to the auditor:
I'm not really excited about the verbiage that we used, as we are being audited against ISO13485:2003. It was my recollection that internal labs within a company do not have to be accredited to 17025. As another colleague point out, "ISO17205 is applicable to calibration vendors performing tests and/or calibrations". This may lead auditors to ask if each and every external vendor is accredited.
During an external audit, the auditor asked if we are accredited to ISO17025. Our answer was no we are not. Here is what we submitted to the auditor:
Is our in-house cal lab accredited to ISO17025?
Answer: No.
Rationale: ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It is applicable to calibration vendor performing tests and/or calibrations. AV quality system is certified to ISO 13485. The ISO 17025 accreditation is not required.
I'm not really excited about the verbiage that we used, as we are being audited against ISO13485:2003. It was my recollection that internal labs within a company do not have to be accredited to 17025. As another colleague point out, "ISO17205 is applicable to calibration vendors performing tests and/or calibrations". This may lead auditors to ask if each and every external vendor is accredited.