2006, Number 2
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ABSTRACTBackground: Clinical Laboratories certification with ISO 15189:2003 Standard, requires the participation and approval of every performed analytical test with External Quality Evaluation Schemes that have been previously recognized by the fulfillment with ILAC G13:2000: Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes. Goal: To review the antecedents, foundations, structure and implications of both standards in order to orient the Clinical Laboratory Professionals in their decision making for the certification process. Method: This is a revision work that was developed during the second semester of year 2005, when we led ourselves to review, to study and to discuss basic the bibliographical information of three documents. Results: Internal Quality Control Programs are essential to achieve precision. Nevertheless it is necessary to complement them with the proficiency programs that are carried out through the External Quality Evaluation Schemes, which represent an additional tool to demonstrate accuracy and in consequence to demonstrate comparability not only between participant clinical laboratories, but also between the available diagnosis systems including analyzers, calibrators, reagents, etc. According to ILAC-G13:2000, External Quality Evaluation Schemes are programs that have been established by an independent, competent organism, with described procedures and free of conflictive interest, that organizes, develops and controls all the processes according to the established guidelines. The fulfillment of ILAC G13:2000, includes the fulfillment of Quality System equivalent to accomplishing the requirements of ISO 9001: 1994, ISO 43-1: 1997, and ISO/IEC 17025:2000. Discussion: As mentioned, ILAC G13:2000 Guidelines, includes the fulfillment of three International Standards in detail, including every issue on planning, organization, development and control of structures, processes and results. Proficiency Testing Suppliers must fulfill every item in order to receive the official recognition to manage External Quality Evaluation Schemes and to generate reliable and opportune results, and to be globally acceptable to evaluate the analytical quality of the laboratories that are working toward ISO 15189:2003 Certification.
ISO/TC 212/WG. Manejo de Calidad en el Laboratorio Médico. Estándar 15189. Diciembre 1998. Organización Internacional de Estandarización.
ILAC G13:2000: Requisitos para la Competencia de Proveedores de Programas para Practicar Ensayos de Aptitud. Comité Internacional Para la Acreditación de los Laboratorios Clínicos.
Secretaría de Salud. Norma Oficial Mexicana NOM-166-SSA1-1997, Para la Organización y Funcionamiento de los Laboratorios Clínicos. Enero-13-2000.