ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 5: Structural and governance requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 5.2.3: Delegation of duties
What does 5.2.3 require?
Particular duties or responsibilities may be delegated by the laboratory director to staff who are qualified and competent, and any delegation shall be documented; overall responsibility for running the laboratory still stays with the director.
This control maps to 4 controls across 3 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
1413-1451 The technical consultant (moderate complexity) or technical supervisor (high complexity, by specialty) provides accessible technical and scientific oversight: method selection, verification of procedures and performance characteristics, PT enrolment and participation, the quality control program and performance parameters, resolution of technical problems and remedial action, no reporting until corrected, training needs and in-service education, competency evaluation using the six required methods, and documented performance evaluation semiannually in the first year then annually or on method change; in cytology the technical supervisor also sets and reassesses workload limits, performs the section 493.1274 reviews, ensures individual PT participation and records their own screening volumes
1463-1471 For high complexity testing the general supervisor is accessible to testing personnel whenever testing is performed, provides day-to-day supervision, is onsite to directly supervise individuals qualified under the high school route, monitors analyses and examinations for acceptable analytic performance and may carry delegated remedial action, result release, orientation and competency duties; the cytology general supervisor is accessible for technical problems and documents slide interpretations, slide counts across all employers and hours per 24-hour period
18(4)-(6) Supervise pathology testing only within the designated person's scope of practice and delegate section 18 responsibilities only as the Supervision Requirements (Eighth Edition 2025) allow, with the scope-of-practice limit relaxed only for a category S laboratory testing in a workforce-shortage discipline
1.03 Delegations: operate an authorisation process that delegates responsibility for aspects of the practice only to workforce members with the qualifications and skills for the task who work within their scope of practice