Diseño de un Sistema de Gestión de la Calidad para la Dirección de Diagnóstico Microbiológico del Centro Nacional de Investigaciones Científicas.

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Bibliographic Details
Title:	Diseño de un Sistema de Gestión de la Calidad para la Dirección de Diagnóstico Microbiológico del Centro Nacional de Investigaciones Científicas.
Alternate Title:	Design of the Quality Management System for the Microbiological Diagnosis Division of the National Centre for Scientific Research.
Authors:	Prieto, Yeniseis Odelín¹ yeni.odelin@cnic.edu.cu, Maletá, Yuleiquis Mediacejas¹, Ruíz, Yaridza Díaz¹
Source:	Revista CENIC Ciencias Biológicas. 2009, Vol. 40 Issue 4, Special section p1-12. 12p. 5 Diagrams.
Subjects:	Pharmaceutical industry, Pharmaceutical industry management, Competition (Psychology), ISO 9000 Series Standards, Current good manufacturing practices, Quality control
Abstract (English):	The development of the Medical-Pharmaceutical Industry has given rise to the need for a Quality Management System (QMS) able to guarantee a better control of the achievement of the Good Practice of Production, and at the same time, reach a higher level of organization and efficiency as a base for client satisfaction and the organization's competitiveness. Based on the aforementioned, the QMS, of the Microbiological Diagnosis Management Office of the National Centre for Scientific Research (CNIC), was designed in this research work. In order to attain this purpose, a diagnosis, which permitted to characterize the real situation of the Management Office regarding the quality, was made releasing non-fulfillment of the norms established by NC ISO 9001:2008 and NC ISO 13485:2005. As part of the design of the QMS, we determined the needs and expectations of the clients and other interested parties; we also identified the processes and the responsibilities required to accomplish the quality objectives. Furthermore, we prepared the documents of the QMS needed to meet the identified requirements, so the changes made could be rigorously controlled, with a view to keeping the essential security characteristics and the efficiency of the products developed and offered by the Management Office. As a fundamental result of the work done, we managed to design the QMS of the Management Office under the most recent international trends in quality management and the ones applicable in the medical equipments sector. [ABSTRACT FROM AUTHOR]
Abstract (Spanish):	El desarrollo de la Industria Médico Farmacéutica ha demandado la necesidad de crear Sistemas de Gestión de la Calidad (SGC) que permitan un mejor control del cumplimiento de las Buenas Prácticas de Producción y, a su vez, lograr un nivel superior de organización y eficiencia como fundamento para la satisfacción de los clientes y para la competitividad de la organización. Teniendo en cuenta este propósito, en el presente trabajo de investigación se diseñó el SGC de la Dirección de Diagnóstico Microbiológico del Centro Nacional de Investigaciones Científicas (CNIC). Con vista a alcanzar este objetivo, se realizó un diagnóstico que permitió caracterizar la situación real de la Dirección respecto a la calidad, dando a conocer incumplimientos de lo establecido en las normas NC ISO 9001:2008 y NC ISO 13485:2005. Como parte del diseño del SGC se determinaron las necesidades y expectativas de los clientes y de otras partes interesadas, se identificaron los procesos y las responsabilidades necesarias para el logro de los objetivos de la calidad y se elaboraron los documentos del SGC necesarios para cumplir los requisitos identificados, de manera que los cambios que se generen puedan ser rigurosamente controlados, con vistas a mantener las características esenciales de seguridad y eficacia de los productos que desarrolla y oferta la Dirección. Como resultado fundamental del trabajo realizado se logró diseñar el SGC de la Dirección bajo las tendencias internacionales más actuales de la gestión de la calidad y las aplicables en el sector de los equipos médicos. [ABSTRACT FROM AUTHOR]
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Database:	MedicLatina

Description
Abstract:	The development of the Medical-Pharmaceutical Industry has given rise to the need for a Quality Management System (QMS) able to guarantee a better control of the achievement of the Good Practice of Production, and at the same time, reach a higher level of organization and efficiency as a base for client satisfaction and the organization's competitiveness. Based on the aforementioned, the QMS, of the Microbiological Diagnosis Management Office of the National Centre for Scientific Research (CNIC), was designed in this research work. In order to attain this purpose, a diagnosis, which permitted to characterize the real situation of the Management Office regarding the quality, was made releasing non-fulfillment of the norms established by NC ISO 9001:2008 and NC ISO 13485:2005. As part of the design of the QMS, we determined the needs and expectations of the clients and other interested parties; we also identified the processes and the responsibilities required to accomplish the quality objectives. Furthermore, we prepared the documents of the QMS needed to meet the identified requirements, so the changes made could be rigorously controlled, with a view to keeping the essential security characteristics and the efficiency of the products developed and offered by the Management Office. As a fundamental result of the work done, we managed to design the QMS of the Management Office under the most recent international trends in quality management and the ones applicable in the medical equipments sector. [ABSTRACT FROM AUTHOR]
ISSN:	02535688