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GMJ Academy

Management Review: Inputs, Outputs, and Real Decisions [T-05-EN]

Risk-based thinking replaced preventive action in ISO 9001:2015. Understand the risk register format, risk rating methods, treatment planning, and the ... Show more
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Understanding ISO 9001 in a Clinic

Management Review: Inputs, Outputs, and Real Decisions [T-05-EN]

Management review is the mechanism through which senior leadership translates quality data into binding organisational decisions — yet in a substantial proportion of healthcare facilities across Georgia and the broader South Caucasus region, these sessions produce discussion records rather than traceable corrective commitments. ISO 9001:2015 replaced the earlier concept of preventive action with explicit risk-based thinking, obligating organisations to demonstrate that identified risks are rated, treated, and reassessed systematically before each review cycle closes. When this requirement is poorly understood or inconsistently applied, certification audits expose gaps that reflect not merely procedural non-conformity but structural failures in patient safety governance. The clinical and institutional stakes are significant: unaddressed quality trends in high-volume settings correlate directly with preventable adverse events and regulatory sanctions under Georgian Law on Medical Activity (N405-IIს) and its implementing technical regulations.

This course is grounded in the normative requirements of ISO 9001:2015 Clause 9.3 and the risk management framework of ISO 31000:2018, interpreted through WHO’s Hand for Quality and JCI’s hospital accreditation standards where these intersect with management review obligations. Content is structured around annotated real-world case material drawn from secondary and tertiary care environments, enabling participants to examine how correctly constructed review inputs — audit findings, key performance indicator trend analyses, customer feedback, supplier performance data, and process conformity results — drive outputs that are specific, owned, time-bound, and auditor-ready. Teaching methodology combines structured reading, decision-simulation exercises, and guided self-assessment against a standardised management review checklist calibrated to current third-party certification practice.

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

  • Distinguish between the mandatory inputs prescribed under ISO 9001:2015 Clause 9.3.2 and supplementary inputs that strengthen organisational decision-making in healthcare contexts.
  • Construct a risk register using a validated risk rating matrix — combining likelihood and consequence scales — that satisfies the documentation requirements auditors examine at surveillance and recertification visits.
  • Design a risk treatment plan that specifies control measures, responsible owners, implementation deadlines, and criteria for residual risk acceptability in alignment with ISO 31000:2018.
  • Evaluate residual risk following treatment implementation, applying consistent re-rating methodology to confirm that risk levels have moved within organisationally defined tolerance thresholds.
  • Implement a management review output structure that converts review conclusions into formally recorded, role-assigned improvement actions with verifiable completion criteria.
  • Analyse audit non-conformity trends and quality indicator data to formulate agenda priorities that direct management review toward clinically and operationally significant quality gaps rather than administrative compliance theatre.

Who Should Attend

This course is designed primarily for medical directors, quality and patient safety managers, and chief nursing officers in licensed healthcare facilities — including hospitals, polyclinics, and diagnostic centres — that operate under or are preparing for ISO 9001 certification or JCI accreditation. It is equally relevant to department heads who chair or contribute evidence to periodic management reviews, and to internal auditors responsible for verifying that review records meet third-party certification standards. Professionals at mid-career and senior levels who hold formal accountability for quality management system performance will derive the most direct benefit.

Course Structure

This is a self-paced online course requiring approximately four to five hours of study, delivered through GMJ Academy’s asynchronous learning environment and assessed by a scored knowledge-check examination requiring a minimum pass mark of 75 percent. Participants who successfully complete the course and assessment receive a GMJ Academy certificate of completion carrying continuing professional development credit recognised within the Georgian medical education framework.

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