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  • 1.  ISO 17025 Calibration

    Posted 08/26/22 08:27 AM

    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?

  • 2.  RE: ISO 17025 Calibration

    Posted 09/03/22 03:30 PM

    @Jason Weaver

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