ISO standards on healthcare enhance patient safety, help streamline supply chains, and foster innovation in digital health and sustainable healthcare solutions.


Healthcare management: Delivering quality to the health industry
ISO 7101, the world’s first-ever standard on managing quality in healthcare organizations, provides much needed guidance for a rapidly evolving sector.

How AI drives innovation in healthcare

Renowned industry expert sheds light on the many opportunities and challenges associated with AI for health. 

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

By Clare Naden on

Medical laboratory testing

How can we trust the results?

Top standards

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

Part 1: General requirements

ISO 13485:2016
Medical devices
Quality management systems

Requirements for regulatory purposes