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ISO 17025

ISO 17025 is the international standard for calibrations. The general requirement to issue ISO 17025 certificates are:

  • The company must have anΒ ISO 9001 certified quality management system, meaning all processes must be documented.
  • The laboratory as such must be mapped and accredited by local authorities (e.g. Switzerland: SAS/SCS, USA: NIST, Germany: DaaKs, UK: UKAS)
  • The calibration method used, including measurement uncertainties, must be documented and accredited by the local authorities.

ISO17025 requires:

  1. Two issuing people giving their approval
  2. The entire process is not just GAMP5 validated but also approved by the accreditation body.

Auditors often prefer ISO 17025 to factory calibrations, since it is a known industry standard set by an official regulatory instance.