Recommendations for Test Lab Regarding Transition to New Requirements GOST ISO/IEC 17025–2019

Abstract

Since September 1, 2019, GOST ISO/IEC 17025–2019 has been enacted as a national standard in the Russian Federation. The novel standard imposes a number of fundamentally new requirements for testing laboratories (hereinafter referred to as the IL or laboratory), and also supplements and specifies the requirements previously regulated by GOST ISO/IEC 17025–2009. In this regard, in order to transfer laboratories to the new requirements, the FSA issued an order in August 2019 listing the mandatory activities that IL must fulfill to bring their activities in line with the new requirements. However, a transition period desired for matching these requirements is absent on a practical level for a number of the laboratories. The purpose of the article is to facilitate a gentle, efficient and pain-free move from the requirements of GOST ISO/IEC 17025–2009 to the new requirements of GOST ISO/IEC 17025–2019, including compliance with new changes in accreditation criteria. We carried out a comparative analysis of the requirements of the new and previous versions of the standard and marked each new and significant item to which the laboratory should pay attention first of all. The new standard focuses on the application of the process approach, risk and opportunity management, as well as on implementation of the policy of impartiality, independence, minimization of competitive interests and confidentiality. The article describes the planning, implementation and monitoring of each event or phase of the transition of testing laboratories to new requirements. Moreover, the recommendations on the structure of the «Quality Manual» and self-assessment on the compliance of IL activities and QMS with the new requirements, including the use of statistical methods for substantiation of the correctness of the assessment are given as an example of the implementation of IL capabilities.