Definition and Analysis of the Main Requirements for Laboratory Competence

Abstract

The work is devoted to the study of the actual issue of technical regulation and metrology — determination of criteria of competence of laboratories.
 The results of the worldwide accreditation work are subjective in nature and therefore require continuous improvement in the assessment methods used to determine the compliance of laboratories with standard competency requirements.
 The analysis of the main elements of the management system, which, in accordance with the Paretto principle, mainly form the competence of laboratories in its accreditation in the national body was held.
 For the first time, the authors, with the involvement of all stakeholders, have analyzed and identified major competency requirements for laboratories across a wide range of DSTU ISO / IEC 17025: 2017 requirements.
 Also, for the first time, the technology of peer review was applied to the analysis of the criteria of competence of laboratories.
 The recommendations of ILAC, EA and EUROLAB international organizations for the criteria of competence of laboratories are analyzed in detail. Particular attention is given to the introduction of specific requirements for staff competence and accreditation criteria, which are in one way or another related to the competence of the laboratory staff.
 It has been established experimentally (by the method of expert evaluation) that such elements of the management system as risk management, personnel management, internal audit, intralaboratory control and interlaboratory comparisons are considered today to be the most important in confirming the competence of a laboratory.