From the 2012 to the 2022 edition: what changed and what your lab must comply with
What ISO 15189 is
ISO 15189 is the international standard specifying quality and competence requirements for medical laboratories. It combines quality management system elements and technical requirements applicable to clinical testing routines in a single document.
According to the International Organization for Standardization (ISO), the standard applies to laboratories developing their management systems and assessing their own competence, and also to users, regulatory authorities and accreditation bodies recognizing that competence.
ISO 15189 does not assess documents alone. It assesses whether the laboratory is technically capable of producing reliable results, consistently, for each test within its declared scope.
ISO 15189:2012 vs ISO 15189:2022: what changed
ISO 15189:2012 was the third edition and served as the accreditation reference for a decade. In December 2022 ISO published the fourth edition, ISO 15189:2022, which cancels and replaces the 2012 edition and also replaces ISO 22870:2016.
The main structural and technical changes are:
- Alignment with ISO/IEC 17025:2017 — management requirements moved to the end of the document, following the parent standard's structure.
- POCT incorporated — point-of-care testing requirements, previously in ISO 22870, are now within scope.
- Risk management — the standard requires planned actions to address risks and opportunities for improvement.
- Documentation flexibility — a quality manual is no longer mandatory as a single document.
- Annex C — provides a clause-by-clause comparison between the 2012 and 2022 editions.
In practice, laboratories still working under the 2012 edition must revisit risk analysis processes, laboratory director responsibilities and POCT control.
Transitioning from ISO 15189:2012 to ISO 15189:2022
Publication of the fourth edition opened a three-year transition period. According to the International Accreditation Service (IAS), at the end of that period the 2012 edition ceases to exist as an accreditation reference, and all accredited laboratories must adapt to the new requirements.
Laboratories seeking new accreditation should work directly from the 2022 edition. Keeping documentation that references only ISO 15189:2012 is now an audit nonconformity risk.
Structure of the standard
ISO 15189:2022 is organized into eight sections. The first three cover scope, normative references and definitions. The remaining sections hold the auditable requirements:
- Section 4 — General requirements: impartiality, confidentiality, patient rights, safety and well-being.
- Section 5 — Structural and governance requirements: legal accountability, laboratory direction, objectives and policies.
- Section 6 — Resource requirements: personnel, facilities, equipment, reagents, consumables and externally provided services.
- Section 7 — Process requirements: pre-examination, examination and post-examination phases, including POCT.
- Section 8 — Management system requirements: documentation, internal audits, corrective actions and management review.
Equipment, calibration and metrological traceability
Section 6 is where the standard touches laboratory infrastructure directly. Equipment used in tests under the accredited scope must be calibrated, periodically verified and carry documented metrological traceability.
This includes purified water systems, incubators, autoclaves, baths, centrifuges, biosafety cabinets and analytical instruments. Each requires calibration records, acceptance criteria and maintenance evidence.
Traceability gaps are among the most recurrent nonconformities in clinical laboratory audits. Holding a certificate is not enough: the laboratory must show the certificate covers the equipment's actual working range.
Qualification of critical systems
Purified water systems, controlled environments and critical equipment require documented qualification (IQ/OQ/PQ) and continuous monitoring. By reinforcing risk-based thinking, ISO 15189:2022 raises the expectation that the laboratory demonstrates control over the variables that can affect a result, not merely formal compliance.
For operations covering metrology, calibration and equipment qualification, this is the link between the standard on paper and daily laboratory practice.
ISO 15189 or ISO/IEC 17025: which applies
ISO/IEC 17025 covers testing and calibration laboratories generally. ISO 15189 is specific to medical laboratories and adds patient-related requirements: consent, confidentiality, clinical information and result interpretation.
A clinical laboratory that also provides calibration services may need both accreditations, with distinct scopes.
Benefits of accreditation
- Formal recognition of technical competence by an accreditation body.
- Fewer errors in pre-examination and post-examination phases.
- Full documentary traceability of results and equipment.
- Acceptance of results across health networks and multicentre studies.
- Structured basis for continuous improvement and risk management.
Together, these gains translate into less analytical rework and greater clinical confidence in the issued report.