El manual de verificación de estándares en calidad en salud pública para laboratorios de alimentos y medicamentos (versión borrador), Comprenden aquellos aspectos administrativos y de gestión que hacen referencia al funcionamiento y los procesos que garantizan la realización de todas las actividades correspondientes al quehacer de los laboratorios, con eficiencia, calidad y oportunidad.
Incluye requisitos como:
1. El laboratorio cuenta con certificación o acreditación de su sistema de gestión de calidad (BPL/ISO17025) (si contesta si continúe con la pregunta 1,10 y sume el puntaje correspondiente a la calificación final de este criterio).
2. El Laboratorio establece e implementa un Sistema de Gestión de Calidad (SGC) buscando garantizar que los procesos y procedimientos que se realizan cumplan las normas, logren los objetivos, y satisfagan cabalmente las expectativas de los beneficiarios del servicio, de acuerdo a su competencia.
3. El laboratorio tiene definido dentro en el sistema de gestión de calidad un plan de auditorías internas, con periodicidad mínima anual para sus procesos.
4. El laboratorio gestiona la dotación de equipos, reactivos, estándares e insumos suficientes para realizar las actividades requeridas en la correcta ejecución de los ensayos y/o calibraciones, en cada área.
El manual aborda aspectos de organización y gestión, talento humano, infraestructura y dotación, sistema de comunicación y registro, referencia y contrarreferencia, bioseguridad y manejo de residuos y procesos prioritarios.
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Manual de verificación estándares de calidad de alimentos y medicamentos
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