Memorias del Instituto de Investigaciones en Ciencias de la Salud
ISSN 1812-9528 versão on-line
SIERRA AMOR, RI. Experiencia de la acreditación de los laboratorios clínicos en México de acuerdo a ISO 15189:2003. Mem. Inst. Investig. Cienc. Salud, dez. 2006, vol.4, no.2, p.55-57. ISSN 1812-9528.
In the area of medical laboratories, the International Standard Organization (ISO) published the ISO15189: 2003 for "Medical Laboratories-Particular requirements for quality and competence". This standard considers that the medical laboratory not only performs assays but also provides medical information based in the analytical interpretation of results supported by medical knowledge. At the same time, it states that the medical laboratory not only has to have quality in the measurements but also in the global service offered to patients. It also considers the specific needs of the medical environment such as turn around time and emergency services, focusing the attention in the needs of the patient and in the contribution of the medical laboratory to patient care without underestimating the accuracy of the measurements. The ISO 15189 uses common terms in the medical area and emphasizes the importance of pre-and post-examination procedures. Finally, it also includes ethical aspects and laboratory results information systems.
Palavras-chave: Accreditation; ISO 15189; quality control.
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