Actualización y generación de documentación parcial de la Norma Técnica ISO 15189:2014 como Sistema de Gestión de Calidad aplicable al Laboratorio Clínico de la Universidad de Cuenca

Abstract

In recent years, Quality Systems have shown that they generate added value to companies, whether production or services. In addition to this, today the demands of control agencies and competition have pushed companies to demonstrate their competence and the degree of confidence they offer in their services. Thus, the present work proposes a Quality System in the Clinical Laboratory of the University of Cuenca, through the documentary implementation, review and updating of the following points: control of documents and records, laboratory procedures, maintenance and calibration. of equipment, infrastructure maintenance, purchases and inventory control that are requirements established by ISO 15189:2014, a specific standard for clinical laboratories. The work began with the situational diagnosis to determine the level of adherence and compliance with the ISO 15189:2014 Standard, then the macro-processes were identified to finally raise and update the corresponding documentation. A total of 23 documents were raised and updated, of which 0% were initially met for management requirements and 30% for technical requirements, the latter being used daily in the clinical laboratory. Finally, 100% compliance with the aforementioned documentation was given, which allows the Clinical Laboratory of the University of Cuenca; carry out their activities in more controlled work environments, detect errors in a timely manner, eradicate them;

Gabriela Elizabeth Ordóñez Mendieta Página 4 and also lead to a future accreditation to demonstrate that the services offered are of quality.