ISO 17025 Calibration

We are a medical device company, certified to ISO 13485, and use multiple pieces of measurement equipment. We are trying to understand what the difference is between ISO 17025 calibration and a normal NIST traceable calibration for hi-pot and ground bond testers; as well as electrical safety testers. Is a ISO 17025 calibration required, or does ISO 17025 just certify the lab performing the calibration? Also, is there a difference between ISO 17025 calibration and standard NIST calibration for simple pieces of equipment like calipers and micrometers?

1 Replies
Duke Okes
257 Posts

@Jason Weaver

ISO 17025 certification applies to the organization, not to a specific device. Traceability to NIST would still be required for specific devices.