Certification / Accreditation

ISO 15189 Medical laboratories and point-of-care testing

ISO 15189 is the international standard for medical laboratories, covering quality and competence in testing human samples for diagnosis, monitoring and treatment. It applies to laboratories of any size and discipline, including point-of-care testing, and shares a structure closely aligned with ISO 17025.

At its core, it’s about patient welfare throughout: informed consent, disclosure of incidents that could affect patient care, and continuity of records if a laboratory closes, merges or is acquired. The current 2022 edition absorbed the previous separate point-of-care testing standard, ISO 22870, which is now withdrawn.

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Who it’s for and what’s involved

Relevant if you are:

A medical laboratory of any discipline

Running point-of-care testing near or at the patient

Establishing a new diagnostic service

Maintaining accreditation through growth or change

Achieving certification involves:

Demonstrating quality and competence across pre, examination and post-examination processes

Appointing a competent laboratory director

Embedding risk management for patient care

Passing a UKAS assessment

How Q! supports certification

Patient welfare at the centre

Patient welfare and risk management sit at the centre of this standard in a way that distinguishes it from more generic management system standards. We work with laboratory directors and personnel to make sure the system reflects that, not just the paperwork. If you are also considering ISO 17025 or ISO 9001, we identify where an integrated system makes sense.

Running point-of-care testing? It’s now covered in the same standard.

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Mini FAQs

ISO 22870, the previous separate standard for point-of-care testing, was withdrawn and absorbed into ISO 15189 in the 2022 edition. Most laboratories already running point-of-care testing will have completed this transition.

The management system requirements were moved to the end of the document to align with ISO 17025:2017’s format, and risk management was given greater prominence throughout. There is no further revision in progress.

ISO 17025 covers testing and calibration laboratories generally; ISO 15189 adapts similar principles specifically for clinical and diagnostic settings, with a much stronger focus on patient welfare and consent.

Often, yes, since patient safety expectations don’t scale down with the size of the laboratory. A smaller service with a well-built, proportionate system can be just as credible to UKAS as a larger one, and accreditation is frequently what allows smaller providers to compete for contracts at all.