Quality diagnosis based on the Iso15189:2012 standard for a private clinical laboratory

Abstract

ISO 15189:2012 is a standard that has reference to the accreditation of clinical laboratories, and has technical guidelines that have become a fundamental pillar for the proper functioning of these laboratories, the central process of a clinical laboratory consists of three stages: the pre-analytical stage, the analytical stage and, finally, the post-analytical stage. Considering these aspects, the objective is to establish a quality diagnosis based on the IISO 15198:2012 standard for a private laboratory, applying a descriptive, cross-sectional analytical methodology. The application of tools was carried out using a questionnaire acquired from the SAE, with two important indicators, management and technical requirements. Among the results that were obtained in the application of results, we found that the quality management and the technical part have a level of compliance and application of 100%, demonstrating that it has all the guidelines based on the ISO 15189: 2012 Standard. the estimation of the level of compliance with the requirements and technical processes that are applied in the laboratory, it was deduced that the vast majority complies with the regulations, therefore, it is established that the private laboratory works with certified and accredited standards, providing effective results For the users.