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

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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.