What is ISO 17025?

ISO 17025 is a sector scheme of ISO 9001. (See What is ISO 9001?) ISO 17025 applies to organizations providing calibration or measurement/testing services. ISO 17025 contains a set of particular requirements specific to the metrology industry that were added to ISO 9001. Roughly, it’s ISO 9001 for metrology organizations and their suppliers. Although ISO 17025 does not include every requirement of ISO 9001, all of them are represented somehow. These are augmented in ISO 17025 with separate technical requirements (see below).

Beyond the basic requirements of ISO 9001, ISO 17025 requires organizations to have additional or enhanced controls over various facets of testing and calibration activities and their management, including:

• Enhanced requirements for organizational responsibilities and authorities to be defined,
• Specific requirements applying to subcontracted testing or calibration and customer notification/authorization thereof,
• Specific technical records are required of ISO 17025. Records of original measurements/observations must be maintained,
• An entire section of ISO 17025 is dedicated to technical requirements:
  • Personnel must be trained and refresher trained in their methods
  • Environmental accommodations must be made to ensure validity of testing/calibrations being performed
  • Enhanced controls are required of test/calibration methods:
    • The selection of methods must be appropriate to the test/calibration sought,
    • Internal/non-standard methods must be clearly stated and observed to ensure consistency and reliability,
    • Methods must be validated to ensure the tests/calibrations being performed produce reliable results,
    • Measurement uncertainty must be evaluated to ensure validity of test/calibration results, and
    • Added controls are in place surrounding data handling and transfer.
  • ISO 17025 contains enhanced requirements pertaining to the qualification and use of equipment used in testing/calibration. Where ISO 9001 requires use of “suitable equipment,” ISO 17025 contains more stringent requirements for the qualification and use of process equipment.
  • Although IS0 9001 contains requirements for measurement traceability, these requirements are expanded upon in ISO 17025.
  • Specific requirements pertaining to the conduct of calibration and testing apply:
    • Calibration and testing activities must be demonstrably performed in accordance with established methods
    • When reference standards and materials are used, they must be appropriately controlled to ensure validity of results,
    • Sampling must be controlled to ensure sampling plans provide appropriate assurance of conformity to requirements,
    • Provisions are in place to review results, assuring their quality, and
    • Requirements pertain to the reporting of results, ensuring reports provide consistent information, including test reports and calibration certificates themselves, as well as any amendments.

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