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Procedure for implementing the system of quality management in the testing laboratory of the Center for Genetic Engineering and Biotechnology in Sancti Spiritus.

By Lídice Peraza Cruz, Vladimir Leal Gómez and Yeleiny Machín León

Abstract

Implementation of Quality Management System in testing laboratories offers the possibility of its accreditation and a frame for cooperation with other organizations, supporting information and experience exchange, as well as standards and procedures harmonization. To improve the performance of the Center for Genetic Engineering and Biotechnology of Sancti Spíritus testing laboratory, assuring technically valid data and results which promote technical competence and credibility of in vitro diagnostics and biological reagents products, a procedure was designed to implement a Quality Management System. This procedure applies Deming´s Quality Cycle and considers all relevant requirements in NC ISO/IEC 17025:2006 “General requirements for the competence of testing and calibration laboratories” and Regulation No. 20 2004 “Good Manufacturing Practices for in vitro Diagnostics” of Center for State Control of Drugs, Equipment and Medical Devices. We recommend an auto evaluation method, designed by authors, to verify quality management system accomplishment

Topics: LABORATORIO DE ENSAYOS, SISTEMA DE GESTIÓN DE LA CALIDAD, General Works, A
Publisher: Centro de Información y Gestión Tecnológica Sancti Spíritus
Year: 2014
OAI identifier: oai:doaj.org/article:e8e30b0f0b564202ad1b698bab6143d9
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