ISO 15189

What is ISO/IEC 15189 Clinical Test Lab Accreditation?

ISO 15189 Medical Laboratories — Particular requirements for quality and competenceis a ‘variant’ standard derived from ISO/IEC 17025 with specific focus on clinical laboratories. The standard covers an ‘end-to-end’ approach to the application of quality assurance methodologies in a clinical environment. This ranges from definition of services offered through to collection of patient samples, sample transport, storage, transportation and test and includes the reporting, interpretation and delivery of test results. The standard also focuses on management responsibilities as well as supporting processes such as facilities, calibration, method validation, training etc

The first version was published in 2003, revised in 2007 and the third edition of the standard was published in 2012. In the UK, the role of clinical laboratory accreditation was previously undertaken by CPA (Clinical Laboratory Accreditation). In 2009 CPA became part of UKAS (the United Kingdom Accreditation Service) and since the latter part of 2013 laboratories have been assessed against the criteria of ISO 15189 instead of the former CPA requirements.