RESUMO
La norma UNE-EN-ISO 15189:2007. Laboratorios clínicos. Requisitos particulares para la calidad y la competencia especifica los requisitos de gestión y los requisitos técnicos que deben cumplir los laboratorios de microbiología clínica que quieran alcanzar un máximo de calidad en la realización de análisis microbiológicos. Con la implantación de esta norma se puede conseguir la acreditación o el reconocimiento formal por una entidad autorizada de la aptitud del laboratorio para realizar un ensayo o un conjunto de ensayos. En España la entidad evaluadora es la Entidad Nacional de Acreditación.Resumen El objetivo de esta revisión es acercar los requisitos de la norma UNE-EN-ISO 15189:2007 a los laboratorios de microbiología, con un enfoque práctico y orientado a los estudios de bacteriología y serología. Se definen brevemente los alcances y se especifican los requisitos que ha de cumplir el análisis microbiológico, el control de la documentación, el aseguramiento de la calidad, el control de los equipos, la gestión del personal, los sistemas de información, suministros y otros servicios externos y, por último, se indican los sistemas de evaluación para monitorizar la mejora continua de los procesos y del servicio prestado por el laboratorio (AU)
The UNE-EN-ISO 15189:2007 standard specifies the management and technical requirements that clinical microbiology laboratories must meet to achieve optimal quality when performing microbiological analyses. With implementation of this standard, a laboratory can receive the accreditation and formal recognition of an authorized body, certifying that it is apt for performing an assay or group of assays. In Spain, laboratories that apply these standards can be accredited by the Entidad Nacional de Acreditación (ENAC, Spanish accreditation body).AbstractThe purpose of this review is to familiarize clinical microbiology laboratory specialists with the UNE-EN-ISO 15189:2007 standard through a practical approach focussed on bacteriology and serology studies. We briefly define the scope and specify the requisites required for managing the quality of the procedures and processes involved in performing tests on human specimens, for document control, and for management of instruments and equipment, personnel, information systems, supply systems, and external services. Lastly, evaluation approaches are indicated to achieve continuing improvement of the processes carried out and the services the laboratory provides (AU)
Assuntos
Humanos , Técnicas de Laboratório Clínico/normas , Ensaio de Proficiência Laboratorial , Técnicas Microbiológicas/normas , Laboratórios/normas , Controle de Qualidade , Gestão da Qualidade TotalRESUMO
The UNE-EN-ISO 15189:2007 standard specifies the management and technical requirements that clinical microbiology laboratories must meet to achieve optimal quality when performing microbiological analyses. With implementation of this standard, a laboratory can receive the accreditation and formal recognition of an authorized body, certifying that it is apt for performing an assay or group of assays. In Spain, laboratories that apply these standards can be accredited by the Entidad Nacional de Acreditación (ENAC, Spanish accreditation body). The purpose of this review is to familiarize clinical microbiology laboratory specialists with the UNE-EN-ISO 15189:2007 standard through a practical approach focussed on bacteriology and serology studies. We briefly define the scope and specify the requisites required for managing the quality of the procedures and processes involved in performing tests on human specimens, for document control, and for management of instruments and equipment, personnel, information systems, supply systems, and external services. Lastly, evaluation approaches are indicated to achieve continuing improvement of the processes carried out and the services the laboratory provides.
