HOW TO AVOID PUTANICS DURING THE QUALITY OF TEST RESULTS AND EVALUATION OF THE CONFORMITY OF TEST METHODS WHEN PERFORMING THE REQUIREMENTS OF ISO/IEC 17025: 2017 STANDARD IN ACCREDITED LABORATORY

Abstract

This article objectively analyzes the problems that arise in the process of the activity of a modern accredited laboratory when implementing the requirements of ISO / IEC 17025: 2017 in terms of ensuring the quality of test results and validating test methods. The characteristic features of these elements of the control system are considered, their main differences, as well as errors, are most often encountered when applying these quality tools in practice. The need for a clear delineation of concepts and criteria for evaluation in the implementation of paragraphs 7.2, 7.6 and 7.7 of ISO/IEC 17025:2017 is described. Among the most influential components that make it possible to achieve this goal, it is possible to rightfully consider such quality management tools as an assessment of the suitability of test methods and the quality assurance of test results. To help specialists of the laboratory practical materials are given - examples of specific requirements of international and European legislative documents, comparative tables, samples of internal documents of the laboratory, etc. It should also be noted that it is necessary to distinguish the criteria for the effectiveness of the method from the tools by which these criteria are established and verified. So, the methods should be effective, their characteristics - relevant, and the test results - guaranteed accurate and reliable.

A quality assurance plan can not be universal, because the same test quality and control tools can not be applied to all test methods. What is suitable for chromatography does not apply to atomic absorption, and that which is suitable for radiological methods is excluded for methods, say, immunoassay. For example, for a radiological test, the "return" tool will not be used, and such tool as "additive test" can not be used for physico-chemical methods such as acidity, mass fraction of protein and fat.