Diseño de un sistema de gestión de calidad con base a la Norma ISO 15189:2012 en el laboratorio clínico de la Clínica Nueva

Abstract

The objective of this research was to design a Quality Management System based on the ISO 15189:2012 standard in the clinical laboratory at Nueva Clinica in Riobamba. The research was of a mixed type according to the characteristics of the data. The qualitative part was the application of the Ecuadorian Accreditation Service (EAS) checklist and the documentation review. The quantitative part was the manipulation of the data obtained from the EAS checklist to produce statistical results, both in the initial and final situation of the laboratory. The obtained results in the initial laboratory analysis were 9% compliance, in this way, the documents necessary to comply with the standard requirements were identified and prepared. Having 87% compliance as a result of the final evaluation of the laboratory. From these results they evidenced the need to implement a Quality Management System, to standardize processes and satisfy customer needs. It is recommended to carry out periodic evaluations of the management and technical requirements, to identify non-conformities in time and carry out corrective measures and / or preventive, giving rise to the continuous improvement of the Quality Management System and give rise to a future accreditation of the laboratory, to provide safety in the health of the Ecuadorian people.