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 5.2.2: Laboratory director responsibilities
What does 5.2.2 require?
Putting the management system into effect is the laboratory director's responsibility, which includes applying risk management across every part of the laboratory's work so that the laboratory systematically finds and deals with both the risks to patient care and the chances to improve it. The director's duties and responsibilities shall be documented.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
1407-1445 The laboratory director takes responsibility for overall operation and administration and for compliance, is onsite at least twice a year at least four months apart with documented visits and remains accessible, directs no more than five laboratories, and ensures quality testing across all three phases, a safe physical plant, adequate methods and verification, PT enrolment with timely results and reviewed reports and corrective action plans, quality control and assessment programs, analytical performance levels, documented remedial action with results withheld until the system works, interpretable reports, client consultation, sufficient qualified staff, training and demonstrated competence before testing, competency monitoring policies, an approved procedure manual, and written duties for every consultant, supervisor and testing person