Quality Management System for Private Clinical Laboratories of Venezuela under the International Standard ISO 15189:2012

Sistema de Gestión de la Calidad para Laboratorios Clínicos Privados de Venezuela bajo la Norma Internacional ISO 15189:2012

Abstract

Nowadays, quality is a fundamental element in the management of companies, it is therefore an important task to maintain and evaluate the degree of quality they have achieved. The objective of the research is “To propose a Quality Management System model in private clinical laboratories in Venezuela under the International Standard ISO 15189:2012.” It is important to highlight that in September 2013 an update to standard 15189:2013 was published – for laboratories. In Europe, the update of their practices was requested according to this new update, effective on March 1, 2016. To achieve this objective, a field investigation and projective research modality will be carried out. It will have the following development phases: know the private clinical laboratories certified under the ISO 9001:2008 standard; determine the level of quality maturity in certified laboratories through Annex “A” of the International Standard ISO 9004:2009, compare the management maturity of certified and non-certified private clinical laboratories and finally design the management model of the quality for private clinical laboratories. Information collection will be done through a questionnaire, structured interviews and direct observation. With the completion of the work, the aim is to guide clinical laboratories that a quality management system provides a guide for the systematic and continuous improvement of the overall performance of the organization, with additional options of achieving certification or accreditation, increasing its impact on the management of all processes and increasing the degree of satisfaction of the expectations of customers and other interested parties.