Diseño de un manual de calidad en base a la norma ISO 15189:2012 para el Laboratorio Clínico del Hospital Básico Pelileo

Abstract

The research project designs a quality manual based on ISO 15189:2012 for the Pelileo Basic Hospital clinical laboratory. The study is quantitative and qualitative; the application of the Ecuadorian Accreditation Service (EAS) checklist and the review of existing documentation in the laboratory were carried out in the qualitative part. The quantitative component was tabulating the data obtained from the list to determine compliance and non-compliance with the initial and final situation of the clinical laboratory. As a result of the first assessment, 53% of non-compliance obtains in the management requirements, which are: advisory service, resolution of claims, dealing with non-conformities, corrective and preventive actions, and concerning the quality management system, in the technicians, 50% of non-compliance was obtained in parameters such as facilities, equipment, reagents, quality assurance, and analytical processes resulting in an average of 51% non-compliance, with the presence of these non-conformities, the quality manual was prepared with the corresponding procedures and records according to the requirements requested by ISO 15189: 2012. With the documentation reviewed and approved in the final evaluation, 80% compliance obtains in the management requirements, and the technicians 84%, resulting in an average of 82% compliance. Based on the quality manual, it recommends implementing a Quality Management System, carrying out a training program for clinical laboratory personnel on quality issues, and managing the necessary economic resources for infrastructure, equipment, and reagents, which help the continuous improvement of the laboratory and provide a quality service to patients