In November 2017, the International Organization for Standardization (ISO) published the revised ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories. The standard specifies the general requirements for the competence, impartiality and consistent operations of laboratories.

ISO/IEC 17025 is useful for any organization that performs testing, calibration or sampling and wants to provide reliable results. This includes all types of laboratories, whether they are owned and operated by government, industry or, in fact, any other organization.

What are the main changes in the ISO/IEC 17025:2017 version?

  • The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing.
  • The terminology has been updated.
  • The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies).
  • The standard has now a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.
  • A new chapter introduces the concept of risk-based thinking.

At its General Assembly meeting held in November 2016, EA adopted the ILAC (International Laboratory Accreditation Cooperation) resolution of a three-years transition period from the date of the publication of the new ISO/IEC 17025.

At the end of the transition period, the accreditation of a laboratory to ISO/IEC 17025:2005 shall not be recognised under the EA Multilateral Agreement. It means that all accreditations of laboratories must be based after November 2020 on the ISO/IEC 17025:2017 version.

EA adopted the ILAC decision to extend the transition period from 30 November 2020 to 1 June 2021 in order to ensure that all laboratories are able to be transitioned under the restrictions imposed as a result of the global COVID-19 pandemic.

The extended transition period has been also adopted by the European Commission and published in the Official Journal of the EU (OJEU). It was very important for EA National Accreditation Bodies, because according to Regulation (EC) No 765/2008, accreditation shall be based on a harmonized standard. In case that the extended transition period would not be published in the OJEU, all accreditations according to the EN ISO/IEC 17025:2005 version would have been revoked after December 2020.

The transition to EN ISO/IEC 17025:2017 has been followed by the EA Multilateral Agreement Council (MAC). By the end of the transition period, end of June 2021, the MAC could confirm that almost all accreditations of laboratories have been successfully transitioned to the new version of the international standard. Only very few laboratories were not able to demonstrate compliance with the EN ISO/IEC 17025:2017 requirements. The accreditations of these laboratories have been suspended or withdrawn by their National Accreditation Bodies.

That means in practice that more than 3.200 calibration laboratories and 18.500 testing laboratories in Europe have demonstrated during the assessments by the National Accreditation Bodies that they are now meeting all the requirements of EN ISO/IEC 17025:2017.

This is a great success and it demonstrates the continued competence of the accredited laboratories in Europe.

You find additional information about:
ISO/IEC 17025:2017 on the ISO website https://www.iso.org/standard/66912.html,
the MAC and the Multilateral Agreement in the EA MLA report https://european-accreditation.org/wp-content/uploads/2021/04/EA-MLA-report-2020.pdf.