La norma UNE 13485 de gestión de la calidad en productos sanitarios es de aplicación en organizaciones que participan en la vida de un producto sanitario desde el diseño y desarrollo pasando por el almacenamiento, distribución, instalación, asistencia técnica, desinstalación o eliminación, así como el servicio técnico necesario para su gestión.

Beneficios

  • Documentación de los procesos. Establece las bases en la gestión de calidad y hace partícipe a la empresa en el proceso de mejora continua.
  • Adecuación a requisitos legales.
  • Proporcionar herramientas contrastadas de gestión; indicadores, medición de la satisfacción del clientes, definición y revisión de procesos, análisis de riesgos, …
  • Mejora la imagen de empresa.
  • Integración con otros certificados. Es integrable con otros protocolos y sistemas de gestión, especialmente ISO 9001, ISO 14001 e ISO 45001.

Herramientas

  • Diagnóstico de situación
  • Reingeniería de procesos
  • KPi´s de gestión
  • Mediciones del nivel de satisfacción

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