ISO 15189:2022

ISO 15189:2012 Medical laboratories

Laboratories are responsible for delivering an average of 300,000 tests every working day in support of the nation’s health services. From blood tests to biopsies covering diagnosis or the ability to monitor treatment progress, medical labs provide the vital test results that inform treatment decisions and health outcomes.

ISO 15189 accreditation underpins confidence in the quality of medical laboratories through a process that verifies their integrity, impartiality and competence. Assessments under UKAS accreditation ensure labs meet the relevant requirements including the operation of a quality management system and the ability to demonstrate that specific activities are performed within the criteria set out in the relevant standard.

Medical laboratories can be accredited to ISO 15189, Medical laboratories – Particular requirements for quality and competence, to demonstrate the quality and reliability of their services.

ISO 15189 was developed with the participation of the medical, scientific, and clinical community, and it contains requirements for diagnostic labs to demonstrate competence to deliver timely, accurate, and reliable results.

Based on ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, and ISO 9001, Quality management systems – Requirements, ISO 15189 includes five additional criteria for medical laboratories

Providing advice on the type of sample and testing that may be required.

Interacting with clinical staff with the laboratory responsible for the quality of service to clinicians referring patient samples for testing.

Providing opinions on results of testing relative to diagnosis and patient care.

Collecting samples or providing information on collection procedures, sample containers, and sample volumes.

Ethical practice.

Why is ISO 15189 Important?

Competence in any field is crucial, but it’s even more pertinent in the medical sphere where the patient’s system is compromised by disease or injury.
ISO 15189 is a mark of confidence awarded to medical laboratories – an accreditation that proves you are dedicated to delivering a proficient and quality service across all aspects of your operation.

With 300,000 tests performed every working day of the year and around 95% of clinical pathways relying on patients having access to pathology services, it’s clear that medical laboratories sit at the heart of a fully-functional modern society. Becoming ISO 15189 accredited will verify three key components of a laboratory: your integrity, impartiality and capabilities. Here’s a little bit more about this crucial ISO standard.

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