შიდა აუდიტი, შეუსაბამობა, CAPA და ხელმძღვანელობის მიმოხილვა [L-03]

შიდა აუდიტი, შეუსაბამობა, CAPA და ხელმძღვანელობის მიმოხილვა [L-03]

Laboratory quality systems do not sustain themselves through accreditation alone — they require continuous, structured self-examination to remain clinically reliable. Across Georgia and the broader South Caucasus region, laboratories pursuing or maintaining ISO 15189 accreditation frequently encounter the same critical gap: the technical capacity to generate data exists, but the institutional competency to evaluate, challenge, and act on that data remains underdeveloped. Undetected nonconformities in pre-analytical, analytical, and post-analytical phases contribute directly to diagnostic error, and the WHO estimates that up to 70 percent of clinical decisions depend on laboratory results, making measurement failures a patient safety issue of the first order. This course addresses that gap by equipping laboratory professionals with the disciplined frameworks that transform internal audit from a compliance exercise into a genuine instrument of quality improvement.

The course is grounded in the normative requirements of ISO 15189:2022 — the international standard for medical laboratory quality and competence — and draws on implementation guidance from the WHO Laboratory Quality Stepwise Implementation (LQSI) framework, CLSI EP23-A risk management guidance, and documented evidence on the effectiveness of corrective and preventive action (CAPA) systems in reducing repeat nonconformities in accredited laboratory environments. Instruction proceeds through case-anchored learning: participants work through realistic audit scenarios, real nonconformity reports, and Levey-Jennings chart datasets drawn from clinical chemistry and haematology contexts, building analytical habits rather than memorising procedural checklists. Assessment is criterion-referenced against the competencies that ISO 15189 and national accreditation bodies, including GEAC, identify as mandatory for laboratory quality managers.

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

• Distinguish between first-party internal audits, second-party supplier audits, and third-party accreditation assessments, and correctly assign audit scope and audit team independence for each scenario.
• Construct a structured internal audit plan that aligns indicator selection with the specific risk profile of pre-analytical, analytical, and post-analytical laboratory processes as defined under ISO 15189:2022 clauses 8.7 and 8.8.
• Interpret Levey-Jennings charts using Westgard multi-rule criteria to differentiate random error from systematic bias, and determine the appropriate corrective response for each pattern observed.
• Implement a documented CAPA workflow — from nonconformity identification and root-cause analysis through corrective action, effectiveness verification, and formal closure — that satisfies ISO 15189 clause 8.7 requirements.
• Evaluate the adequacy of quality indicator data across defined collection cycles, applying statistical thresholds to determine when a trend constitutes a signal requiring escalation versus normal process variation.
• Design a management review agenda that systematically integrates audit findings, nonconformity trends, external quality assessment outcomes, and resource adequacy assessments into actionable decisions, fulfilling the governance obligations specified in ISO 15189:2022 clause 8.9.

Who Should Attend

This course is designed for laboratory quality managers, senior medical laboratory scientists, and clinical laboratory directors working in hospital, reference, or public health laboratory settings who hold direct responsibility for quality system documentation and accreditation readiness. It is equally relevant to pathologists and laboratory physicians in Georgia and neighbouring countries who participate in management review processes or oversee institutional accreditation programmes. Mid-career professionals preparing for GEAC accreditation assessments or ISO 15189 surveillance audits will derive the most immediate practical benefit.

Course Structure

The course is delivered entirely online through the GMJ Academy learning environment, comprising approximately five to six hours of structured study across video-based instruction, interactive case analyses, and a graded competency assessment requiring a minimum score of 75 percent for successful completion. Participants who meet the assessment threshold are eligible to receive a GMJ Academy certificate of completion carrying continuing professional development credit in accordance with the Georgian Medical Council CME recognition framework.