ISO 15189:2022 ლაბორატორიის დირექტორისა და ხარისხის მენეჯერისთვის [L-01]

ISO 15189:2022 ლაბორატორიის დირექტორისა და ხარისხის მენეჯერისთვის [L-01]

Medical laboratory errors account for a disproportionate share of adverse clinical events: WHO estimates that up to 70% of clinical decisions rely on laboratory results, yet pre-analytical, analytical, and post-analytical failures continue to compromise patient safety in settings where quality systems remain immature. ISO 15189:2022 — the internationally recognised standard for medical laboratory quality and competence — provides the normative framework to systematically eliminate these failures, but its effective implementation requires leadership that understands both its architecture and its operational demands. In Georgia and across the South Caucasus, where accreditation programmes aligned with international benchmarks are expanding under national healthcare reform agendas, the ability of laboratory directors and quality managers to translate this standard into auditable practice has become a professional necessity, not an optional credential.

This course is grounded directly in the normative requirements of ISO 15189:2022, interpreted alongside the WHO Laboratory Quality Management System (LQMS) framework and Joint Commission International (JCI) laboratory accreditation criteria. Content is delivered through structured didactic modules reinforced by document analysis exercises and scenario-based decision tasks drawn from real accreditation cycles, enabling participants to move from conceptual understanding to applied competency within a single, cohesive learning experience.

By the end of this course, participants will be able to:

• Distinguish the structural differences between ISO 15189:2022 and its 2012 predecessor, identifying the specific clauses that impose new obligations on laboratory leadership and quality personnel.
• Analyse the defined responsibilities of the laboratory director and quality manager under Clause 5 and Clause 6 of ISO 15189:2022, mapping each role to concrete operational and governance tasks.
• Construct a compliant document control system — encompassing policies, standard operating procedures, records, and forms — that satisfies the traceability and version-control requirements stipulated in Clause 8.4.
• Apply the standard’s requirements for risk-based thinking (Clause 8.5) to identify and prioritise quality risks within their own laboratory’s pre-analytical, analytical, and post-analytical processes.
• Design an internal audit schedule and corrective-action workflow that fulfils the conformity assessment expectations of accreditation bodies operating under ISO/IEC 17011.
• Evaluate the readiness of a laboratory’s quality management system against ISO 15189:2022 requirements using structured gap-analysis criteria, generating actionable findings suitable for a formal management review.

Who Should Attend

This course is intended for laboratory directors, deputy directors, and quality managers working in hospital-based, reference, or public health laboratories at any stage of the ISO 15189 accreditation journey — from initial gap assessment through to surveillance audit preparation. It is equally relevant to senior medical technologists and laboratory supervisors who bear delegated responsibility for document management or internal quality assurance, and to healthcare administrators overseeing laboratory services within multi-site clinical networks in Georgia or the broader South Caucasus region.

Course Structure

The course is delivered entirely online through the GMJ Academy platform in a self-paced format, requiring an estimated six to eight hours of study time inclusive of video lectures, document analysis exercises, and a summative knowledge assessment; participants who achieve a passing score of 80% or above will receive a GMJ Academy certificate of completion carrying continuing professional development (CPD) credits recognised within Georgia’s ongoing healthcare quality improvement framework.