Implementación parcial de la norma técnica ISO 15189:2014 como un sistema de gestión de la calidad que se aplicará al Laboratorio Clínico de la Universidad de Cuenca

Abstract

The quality of a Clinical Laboratory be defined as the accuracy, guarantee, reliability of the results reported to patients and it is a public/private space that is intended to provide qualitative, semi-quantitative and quantitative analysis data, to contribute to the prevention, diagnosis and treatment of pathologies, for which the Clinical Laboratory must have a quality management system that gives it the ability to produce technically valid results based on the ISO (International Organization for Standardization) 15189 standard, control over its processes. The purpose of this degree work is to continue the implementation of a Quality Management System based on the Technical Standard ISO 15189:2014 (NT-ISO 15189:2014) for the Clinical Laboratory of the University of Cuenca and demonstrate a quality and guarantee in laboratory activities. At the beginning of this work, an observational diagnosis was made in which we could find the lack of documentation to carry out a quality management system, so we proceeded to make a matrix of macro and micro processes based on the requirements of the ISO Standard. 15189:201 and finally the implementation of these requirements to the Clinical Laboratory of the University of Cuenca was analyzed. In addition, as a result of the implementation of the aforementioned Standard, correctly established procedures were obtained and are applicable to daily activities for the control and continuous improvement of quality management of the Clinical Laboratory of the University of Cuenca.