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ISSN 0185-6014 (Print)
Órgano oficial de difusión de la Federación Mexicana de Patología Clínica, AC y de la Asociación Latinoamericana de Patología Clínica/Medicina de Laboratorio

2015, Number 1

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Rev Mex Patol Clin Med Lab 2015; 62 (1)

Assessment of three guidelines for the implementation of the quality management system

Zamora-Palma A

Language: Spanish
References: 22
Page: 11-15
PDF size: 244.35 Kb.


ABSTRACT

The aim of this paper is to present an analysis of the structure of quality management systems based on elementary concepts and the standards currently used as the basis for achieving continuous improvement of laboratories. At the same time, the commonalities between the ISO 9001, the ISO 15189 and the requirements of the Latin American guidelines for improving the quality, bioethics and medical relevance of laboratories are compared. The results of the accreditation survey of 28 laboratories accredited by the standard ISO 15189 in Mexico show that we are seeking recognition by a standard not suited to the economic and legislative reality of most Latin American countries, without the expeditious support of the national accreditation entity and facing high costs for a process that will yield, if accomplished, only medium benefits.


REFERENCES

  1. http://ilac.org/

  2. ISO 9000:2008 Requisitos generales del Sistema de Gestión de Calidad.

  3. Diccionario de la Real Academia de la Lengua española. www.rae.es.

  4. ISO/IEC 17025:2000 Requisitos generales para la competencia de los laboratorios de ensayo y de calibración.

  5. NMX-EC-15189-IMNC-2012, Laboratorio clínico, competencia y acreditación

  6. Terrés SAM et al. Guía Latinoamericana para la Mejora de la Calidad, Bioética y Relevancia Médica de los Laboratorios (PROMECAL). Rev Latinoam Patol Clin Med Lab. 2013; 60 (3): 141-165.

  7. International Laboratory Accreditation Cooperation. http://ilac.org/

  8. Sociedade Brasileira de Patología Clínica. www.sbpc.org.br

  9. SBAC - Sociedade Brasileira de Análises Clínicas. www.sbac.org.br/

  10. College of American Pathologists. www.cap.org

  11. The American Association for Laboratory Accreditation (A2LA). https://www.a2la.org.

  12. Entidad Mexicana de Acreditación AC. www.ema.org.mx

  13. ECA -- Ente Costarricense de Acreditación. www.eca.or.cr/

  14. Entidad Nacional de Acreditación (ENAC). www.enac.es/

  15. Organismo Uruguayo de Acreditación. www.organismouruguayodeacreditacion.org/

  16. Organismo Argentino de Acreditación (OAA). www.oaa.org.ar

  17. Servicio de Acreditación Ecuatoriano |. www.acreditacion.gob.ec/

  18. DAkkS. www.dakks.de/

  19. Cofrac - Comité français d’accréditation. www.cofrac.fr/

  20. The United Kingdom Accreditation Service. www.ukas.com/

  21. DANAK - Den danske akkrediteringsfond. www.danak.org/

  22. Croatian Accreditation Agency. www.akreditacija.hr/EN




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