ISO 15189 requirements explained: video brief

Five clauses built around the patient sample

ISO 15189:2022 is organised in five requirement clauses, 4 to 8, in the same pattern as ISO/IEC 17025:2017 rather than the harmonised structure of the management system standards. Clauses 4 to 7 cover the laboratory, its resources and the path of a sample from request to report, and clause 8 covers the management system that supports them. Annex A adds the requirements for point-of-care testing. This short film walks through that structure.

Clause 4 covers impartiality, confidentiality and requirements regarding patients: their information, consent, safety, welfare and access to the service. In practice that means an impartiality assessment covering ownership, commercial pressure and referral arrangements, confidentiality undertakings for staff, students and contractors, and arrangements for patient information, consent and complaints. Clause 5 sets the structural and governance requirements, including a legal entity and a laboratory director with defined responsibilities.

Resources, process and the management system

Clause 6 covers the resources the laboratory needs: competent personnel, facilities and environmental conditions, equipment, calibration and metrological traceability, reagents and consumables, and externally provided products and services. Clause 7 follows the sample through the pre-examination, examination and post-examination processes, including method verification and validation, measurement uncertainty, reference intervals, ensuring the validity of results, reporting and the handling of complaints and nonconforming work.

Clause 8 sets the management system requirements, and Annexes B and C compare the standard with ISO 9001:2015 and with the 2012 edition. The standard applies to medical laboratories of every size and discipline, from clinical chemistry and haematology to microbiology, histopathology and molecular diagnostics. Accreditation is granted by an accreditation body for a defined scope of examinations and maintained through surveillance and reassessment; the 2022 edition replaced ISO 15189:2012 and ISO 22870:2016.

A health authority licence or an ISO 9001 certificate does not satisfy ISO 15189: the standard adds the technical requirements, from the laboratory director and competence per examination to method verification, measurement uncertainty, reference intervals, internal quality control and external quality assessment. Pre-examination arrangements stay the laboratory's responsibility even when the wards collect the samples, and assessors follow a sample from collection to report.