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

Insights

Healthcare’s digital transformation: Telemedicine, data protection and cybersecurity

Health is what we all have in common. When it’s protected, it empowers people to prosper; but when it’s neglected, it can have devastating consequences, not just for individuals but for entire communities.

An easy guide to understanding healthcare data analytics

In this brave new world, virtually every person generates data. Like many industries, the healthcare sector is increasingly moving towards data as the foundation of its decision making.

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.

Top standards

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

Part 1: General requirements

Standard
ISO 13485:2016
Medical devices
Quality management systems

Requirements for regulatory purposes