Validation of test methods

This article examines the process of validation of test methods in testing laboratories and its difference from the verification process. The article describes the stages of validation, accepted standards and methods for evaluating the metrological characteristics of measurement methods. The main purpose of validation of test methods is to ensure the accuracy, reliability and repeatability of test results. Validation is necessary not only in testing, but also in calibration laboratories. This work also reviews the main stages of validation of methods. Validation is a test conducted in accordance with the methodology and a conclusion on whether the conditions are met. The procedure for validating the methodology in the laboratory is based primarily on the GOST R ISO 17025 standard, an international standard that allows you to maintain the performance of tests even according to international standards for appropriate test facilities. Validation is also the main criterion for accreditation for laboratories, when implementing the method, appropriate records are made, a protocol is drawn up, which is evidence of the implementation of the method. There are a number of problems associated with conducting validation in the laboratory and maintaining this process in the management system. As part of this work, the main problems and the causes of their occurrence will be considered.