title: [Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].
abstract: The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory.
authors: Programa de Control de Calidad Externo SEIMC. r.guna@terra.es
authors: M del Remedio
authors: Mdel R
authors: Guna Serrano
authors: M Dolores
authors: MD
authors: Ocete Mochón
authors: M José
authors: MJ
authors: Lahiguera
authors: M Carmen
authors: MC
authors: Bresó
authors: Concepción
authors: C
authors: Gimeno Cardona
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D009161:Mycobacterium; D013030:Spain