Patient safety
Risks across the testing process identified and controlled.
Accreditation readiness
ISO 15189 Medical Laboratories
Current edition: ISO 15189:2022
The international standard for quality and competence in medical laboratories. It focuses on patient care: from the request and sample, through examination, to the result the clinician acts on. We prepare medical laboratories for accreditation.
2022Only valid edition
The 2012 edition is no longer accepted
The transition to ISO 15189:2022 ended in December 2025. The 2022 edition strengthens risk management focused on patients, aligns structure with ISO/IEC 17025, and brings point-of-care testing requirements, previously in ISO 22870, into the standard.
What the standard covers
Requirements, clause by clause
ISO 15189:2022 follows the structure of ISO/IEC 17025, with requirements across the full examination process.
4
General requirements
Impartiality, confidentiality, requirements regarding patients.
5
Structural and governance
Legal entity, laboratory director, scope, risk management.
6
Resource requirements
Personnel, facilities, equipment, calibration and traceability, reagents and consumables, agreements.
7
Process requirements
Pre-examination, examination and post-examination processes, validity of results, reporting, POCT.
8
Management system
Option A requirements, or Option B in line with ISO 9001.
Risk management throughout focuses on harm to patients, not only on the laboratory's operations.
Why organisations implement it
What accreditation delivers
Clinical confidence
Clinicians and health systems trust accredited results.
Regulatory recognition
Accreditation is required or expected by many health authorities and payers.
Consistent POCT
Point-of-care testing brought under the same control.
Fewer errors
Pre-examination controls reduce sample and identification errors.
International acceptance
Recognition through the Global ACI mutual recognition arrangement.
How we work
Path to accreditation
One AEC methodology from first assessment to accreditation, delivered by registered lead auditors.
- AssessGap assessment against ISO 15189:2022 and accreditation body requirements
- DesignProcedures, impartiality risk assessment, competence and method records
- ImplementProcesses run on real work, records generated
- TrainStaff trained, competence assessed and authorised
- VerifyInternal audit, management review, mock assessment
- Accredit & sustainSupport through the assessment and surveillance
Full build
We design the management system and technical records from the start.
Typically 9 to 12 monthsAccreditation readiness
We close gaps in existing processes before you apply.
Typically 6 to 9 monthsTransition or scope extension
We prepare transitions to new editions, or new methods and sites for your scope.
Typically 2 to 6 months
Who decides
Accreditation by your national accreditation body
Medical laboratories are accredited by national accreditation bodies such as UKAS, DAkkS or PNAC. Accreditation under the Global ACI mutual recognition arrangement is recognised internationally. AEC prepares your organisation for the assessment; the accreditation decision is theirs.
Independent
We prepare you for the accreditation body your customers and regulators recognise.
Assessment-ready
Mock assessment and closed findings before the accreditation visit.
No guarantees
We prepare you thoroughly and never promise an outcome only an accreditation body can decide.
Where it applies
ISO 15189 by industry
Healthcare · hospital and reference laboratories
Government · public health laboratories
Education · university teaching laboratories
Related standards
Questions
ISO 15189 FAQ
Does AEC accredit medical laboratories?
No. Accreditation is granted by national accreditation bodies. AEC prepares your laboratory for that assessment.
We are accredited to ISO 15189:2012. Are we still accredited?
The transition to ISO 15189:2022 ended in December 2025. If your laboratory has not transitioned, contact your accreditation body; we can run a focused gap review against the 2022 edition.
Does ISO 15189 cover point-of-care testing?
Yes. The 2022 edition includes requirements for point-of-care testing that were previously in ISO 22870.
ISO 15189 or ISO/IEC 17025?
Medical laboratories examining human samples for diagnosis use ISO 15189. ISO/IEC 17025 applies to testing and calibration laboratories more generally.
Prepare for ISO 15189 accreditation
Tell us your examinations, sites and current processes. We reply with a proposal covering gap assessment, process design and accreditation readiness.
Accreditation decisions are made by national accreditation bodies. AEC prepares organisations for accreditation and does not guarantee outcomes.