Updated edition of ISO medical lab standard published

Published: 6-Feb-2013
Regulatory Microbiology Medical Devices Pharmaceutical

Large number of UK medical labs are expected to migrate to new standard by 2018, says UKAS


ISO 15189:2012 - the updated (third) edition of standard the “Medical laboratories – Requirements for quality and competence” has been published and cancels the second edition.

Intended to improve the quality and reliability of medical laboratories, the standard was first published in 2003, and the latest update has been eagerly anticipated by the medical industry after input from organisations including the Association of British Healthcare Industries (ABHI) and the British In Vitro Diagnostics Association (BIVDA).

It is expected that up to 1,000 UK medical laboratories could adopt the standard, particularly in light of the United Kingdom Accreditation Service (UKAS) announcing a migration of all medical lab accreditation to ISO 15189:2012.

Lorraine Turner, UKAS’ Business Development Director, said: “ISO 15189 covers the essential elements for medical laboratories to demonstrate the quality and competence of their services, as well as to consistently deliver technically valid tests. The standard, which has been developed with strong involvement from the medical, scientific and clinical community, is for use by medical laboratories in developing their management systems and maintaining their competence; it is also used by accreditation bodies as criteria to confirm the competence of these laboratories through accreditation.“

ISO 15189:2012 is closely aligned to the requirements for testing and calibration laboratories ISO/IEC 17025 and the widely respected quality management standard ISO 9001. This makes it an attractive option for medical laboratories operating in the fields of clinical chemistry, microbiology, biochemistry and other areas of pathology as well as those bodies involved in their assessment.

Shirley Bailey-Wood, BSI’s Director of Publishing, said: “The optimal performance of medical laboratories is absolutely critical and the industry has eagerly awaited this standard to provide the very latest guidance available. The announcement from UKAS that it will be migrating its accreditation to ISO 15189:2012 underlines their confidence in this standard and serves as a call to the medical industry to promptly adopt this best practice framework.“

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