• 作者：Marí ; a Dolores Rojo^a ; ^{md.rojo.sspa@juntadeandalucia.es} ; Juan Manuel Aguiar^b ; Emilia Cercenado^c ; Fernando de Ory^d ; Manuel de la Rosa^a
• 关键词：Calidad ; Laboratorio de microbiolog&iacute ; a cl&iacute ; nica ; Acreditació ; n ; ISO 15189
• 刊名：Enfermedades Infecciosas y Microbiolog铆a Cl铆nica
• 出版年：2010
• 期刊代码：pca153_0213005X
• 类别：med
• 出版时间：November 2010
• 卷：28
• 期：9
• 页码：629-637
• 文件大小：225 K

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 Acreditaci贸n (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.