ISO 15189 - Medical laboratories
The medical laboratory standard. Stipulates the operational quality and compliance benchmarks required by the modern laboratory.
Toolkit
Navigate the clauses and actions required for ISO 15189
Quick reference guide
Quick start guide
Quick reference guide
Regulatory udpates
Recent amendments
ISO 15189:2012 will be going through a revision in the next couple of years. This will bring it into line with the updated structure of ISO standards such as ISO 9001:2015. In Scotland, ISO 15189: 2012 is mandatory for all medical laboratories.
Additional reading