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ISO/IEC 17025 – GENERAL REQUIREMENTS FOR THE COMPETENCES OF TESTING AND CALIBRATION LABORATORIES

The new ISO 17025:2018 standard renews the previous revision – dated 2005 – defining the requirements for laboratories that intend to get accreditation for testing and calibration.

The structure of the standard is different from the other standards for management systems; it is indeed focused on the elements (resources, process) which must characterize a laboratory.

As for the management system – unlike the previous version that took over the requirements of ISO 9001 – the new ISO 17025 standards proposes 2 options:

– Option A: including basic management elements

  • Option B: adopting the ISO 9001 model

This choice of the regulator is intended to favor small laboratories, which often complain they have no resources to implement a complete management system.

It should also be emphasized that the HLS model of ISO 9001 guarantees the laboratory a more adequate and effective management system.

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The aspects of competence include, for all laboratories:

in-depth knowledge of measurement techniques and the technologies that characterize them

– the mastery of the analytical methodologies that allow to determine the measurement uncertainty

For the testing laboratories, the competence necessarily extends also to the materials and products object of the tests.

In Europe, Regulation 768/2008 establishes the reference framework for all those who exercise a third party role; this means that the accredition body for the laboratories is defined by national regulations.