SISTEMA DE GESTIÓN DE LA CALIDAD PARA LABORATORIOS CLÍNICOS PRIVADOS DE VENEZUELA BAJO LA NORMA INTERNACIONAL ISO 15189:2012
Authors: Luz M. Carrero-Gomez , Desireé Vázquez
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Nowadays, Quality is a key aspect in Companies Management; therefore, it is important to maintain and assess the level of quality achieved. This research aims to "Propose a Quality Management System Model for private medical laboratories in Venezuela, according to the ISO 15189: 2012". It is important to note that an update of the standard 15189: 2013 for laboratories was published in September 2013. In Europe, it was requested to update practices according to this new update, in force since March 1, 2016. In order to fulfill this objective, a field research and projective research modality will be carried out , consisting of the following stages of development: To identify private medical laboratories certified under the ISO 9001: 2008 ; to determine the level of quality maturity in certified laboratories through Annex "A" according to the ISO 9004: 2009, to compare the management maturity of certified and non-certified private medical laboratories, and finally, to design the Quality Management Model for private medical laboratories. Data will be collected through questionnaire, structured interviews, and direct observation. The work is aimed at guiding medical laboratories to a Quality Management System which provides a guide for consistent and continuous improvement of the organization overall performance, with additional options to achieve certification or accreditation, thus increasing its impact over management of all the processes, and enhancing the level of satisfaction of customers and stakeholders’ expectations.