Las normas ISO sobre sanidad mejoran la seguridad de los pacientes, ayudan a agilizar las cadenas de suministro y fomentan la innovación en las soluciones de sanidad digital y sanidad sostenible.

Perspectivas

Gestión sanitaria: Aportar calidad al sector sanitario
ISO 7101, la primera norma mundial sobre la gestión de la calidad en las organizaciones sanitarias, proporciona una orientación muy necesaria para un sector en rápida evolución.

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Gloved hands of a hospital emergency doctor placing a swab into a tube after testing.

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Medical laboratory testing

How can we trust the results?

Top standards

Norma
ISO 14644-12:2018
Cleanrooms and associated controlled environments
Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration
Norma
ISO 15189:2022
Medical laboratories
Requirements for quality and competence
Norma
IEC 62304:2006
Medical device software
Software life cycle processes
Norma
ISO 14644-1:2015
Cleanrooms and associated controlled environments
Part 1: Classification of air cleanliness by particle concentration
Norma
ISO 15223-1:2021
Medical devices
Symbols to be used with information to be supplied by the manufacturer

Part 1: General requirements

Norma
ISO 13485:2016
Medical devices
Quality management systems

Requirements for regulatory purposes