September 20, 2019
The intergovernmental standard GOST ISO/IEC 17025–2019 General requirements for the competence of testing and calibration laboratories entered into force September 1, 2019. It was prepared by the Republican Unitary Enterprise “Belarusian State Centre for Accreditation” based on the translation of the English version of the standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories into the Russian language and adopted by the EURO-ASIAN COUNCIL for standardization, metrology and certification.
The new intergovernmental standard replaced GOST ISO/IEC 17025-2009. The document entered into force as the national standard September 1, 2019. The relevant decision was made by the Federal Agency on Technical Regulating and Metrology (Rosstandard) July 15, 2019.
Due to the absence of a transition period for the intergovernmental standard GOST ISO/IEC 17025-2019, Russian laboratories seek an answer to the following questions: How to reorganize their activity fast? How will the assessments be made? How to confirm laboratories’ compliance with the new standard’s requirements? Let us try to understand.
It is important to underline that already in 2017 the Federal Service for Accreditation informed about the forthcoming transition to a new version of ISO/IEC 17025. RusAccreditation official website provided a link to the International Organization for Standardization website where one could study in detail the materials on the transition to the new standard and purchase the original English version of it.
Preparation and registration of the official translation into the Russian language of the international standard ISO/IEC 17025:2017 was performed by the Technical Committee for Standardization “Conformity Assessment” (TC 079) as part of implementing the National Standardization Program for 2018. Since July 2018 the official Russian version of the new standard has also become available on the Federal State Unitary Enterprise “Standardinform” website. Therefore, the changes were not a surprise for testing and calibration laboratories.
The Order of RusAccreditation No. 144, issued on August 9, 2019, approved the Transition plan for the members of the national accreditation system to the application of the international standard ISO/IEC 17025:2017. Information was published on the RusAccreditation official website the same day.
It is worth mentioning that those laboratories which studied the new version of the international standard that is the basis for GOST and prepared for the transition beforehand do not face any difficulties now. Representatives of such laboratories shared their experience with colleagues at the last meeting of RusAccreditation Public Council Committee on issues of testing laboratories (centers) activity.
What is most important to take into consideration is the mandatory application of the standard by accredited laboratories starting from the date when the changes to the accreditation criteria and the list of standards come into force, meeting the requirements of which ensures compliance with the accreditation criteria. This also extends to public services that had been registered before the mentioned changes came into force and that did not undergo an on-site assessment.
The changes to the accreditation criteria have been adopted, therefore, laboratories that are not to date ready to operate in compliance with the new requirements have to implement the transition plan
Laboratories that await (before changes to accreditation criteria come into force) on-site assessment can make a choice regarding the compliance with the requirements of which standard they prefer to be assessed for: GOST ISO/IEC 17025-2009 or GOST ISO/IEC 17025-2019. Not forgetting, at the same time, about the mandatory requirements of the existing accreditation criteria.
Laboratories shall inform RusAccreditation and the lead assessor about the choice they make. The notification shall be prepared in an arbitrary form and signed by the head of a legal entity, or a person acting on behalf of the head of a legal entity, or an individual entrepreneur.
What laboratories need to do in the near future
Perform a self-assessment if it has not been done yet.
Complete a self-assessment form for the compliance with GOST ISO/IEC 17025-2019, in other words to assess which changes are to be introduced in management system documentation in order to comply with the requirements of the new standard.
Update management system documentation.
Conduct an internal audit on implementing the updated requirements.
Elaborate a plan of action intended for capacity building of staff.
As part of the confirmed transition plan there is free access to the online training course of the Asia Pacific Accreditation Cooperation on the introduced changes to the standard ISO/IEC 17025 at the national accreditation system unified educational platform. The course is revised by the National Institute for Accreditation of RusAccreditation specialists and consists of APAC video lectures, presentations and documents on the application of the international standard ISO/IEC 17025 translated into Russian.
Realization of this project has become possible after RusAccreditation became a signatory to the Asia Pacific Accreditation Cooperation Mutual Recognition Arrangement (APLAC MRA) in 2017 and a member of APAC after the merger of APLAC and PAC on January 1, 2019.
In addition, since August 19, 2019, the National Institute for Accreditation of RusAccreditation has been implementing an updated educational project for applicants, accreditation bodies, experts and assessors regarding topical issues in the transition to the new version of the standard ISO/IEC 17025, key changes and its practical application.
The educational project elaborates on the changes introduced to the document: terms and definitions, general and specific requirements, as regards impartiality, confidentiality, structure of a testing and calibration laboratory, resources, processes, and management system.
Special attention is paid to the risk-oriented approach to laboratories’ activity, metrological traceability. Tasks for self-training are also provided.
Attendant control system with an individual QR-code has also been introduced, as well as mandatory final testing, in order to assess to what extent the materials are brought to the interested parties and specialists who are planning to improve their competence, and whether they are fully understood. It is important for the listeners to receive reliable information.
As Josh Billings, the 19th century American literator, said, “You’d better not know so much, than to know so many things that ain’t so.”