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GMJ Academy

Internal Audit — Planning, Performing, Reporting [T-03-EN]

Context and interested parties determine the scope of your QMS. Apply PESTLE and SWOT analysis, map your stakeholders, and define ... Show more
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Understanding ISO 9001 in a Clinic

Internal Audit — Planning, Performing, Reporting [T-03-EN]

Internal audit is the primary mechanism by which a quality management system (QMS) generates evidence of its own effectiveness — yet in healthcare settings across the South Caucasus and beyond, audit programmes routinely exist as administrative formalities rather than genuine instruments of improvement. The Joint Commission International (JCI) and ISO 9001:2015 both identify systematic internal auditing as a core requirement for sustained certification and organisational learning, and WHO’s Global Patient Safety Action Plan 2021–2030 explicitly links structured audit cycles to measurable reductions in adverse events. When internal audits are superficial or inconsistently executed, organisations lose the feedback loop that allows them to detect process drift before it reaches the patient. This course addresses that gap directly, equipping participants with the technical and analytical competencies to run a complete, defensible audit cycle from first principles.

The course is grounded in ISO 19011:2018 — the international guidelines for auditing management systems — and aligned with ISO 9001:2015 requirements for planning, conducting, and documenting internal audits. Instructional content draws on auditor competency frameworks published by the International Register of Certificated Auditors (IRCA) and incorporates illustrative cases from Georgian and regional healthcare accreditation experience to contextualise abstract standard requirements. Participants learn through structured worked examples, annotated document templates, and scenario-based audit simulations that mirror the conditions of a real third-party certification visit.

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

  • Construct a risk-based annual audit programme that prioritises processes according to their patient safety significance and alignment with ISO 9001:2015 Clause 9.2 requirements.
  • Design an audit plan and checklist for a specific departmental process, translating standard clauses into verifiable, context-specific audit criteria.
  • Apply objective evidence-gathering techniques — including document review, staff interview, and direct observation — to distinguish conformity from nonconformity with documented requirements.
  • Analyse audit findings to distinguish between isolated defects and systemic nonconformities, correctly classifying each as a major nonconformity, minor nonconformity, or opportunity for improvement per ISO 19011 definitions.
  • Construct a complete audit report that meets ISO 9001:2015 and certification body expectations, including a clear statement of scope, criteria, findings, and conclusions presented in language accessible to senior management.
  • Evaluate corrective action plans submitted in response to audit findings, verifying that root cause analysis is adequate and that proposed actions address systemic rather than symptomatic causes.

Who Should Attend

This course is designed for quality managers, QMS coordinators, and designated internal auditors working in hospitals, polyclinics, diagnostic centres, and primary care networks — particularly those preparing for initial ISO 9001 certification or periodic surveillance audits. It is equally relevant to clinical department heads and senior nurses who hold functional responsibility for process documentation and improvement cycles within their units. Professionals at early-to-mid career stage who have completed foundational QMS awareness training will derive the greatest benefit, though no formal auditor qualification is required for enrolment.

Course Structure

The course is delivered fully online through the GMJ Academy platform and requires approximately six to eight hours of self-paced study, comprising video instruction, annotated reference documents, and three scenario-based assessments that simulate real audit conditions. Participants who achieve a passing score of 80% or above on the final assessment receive a GMJ Academy certificate of completion carrying CPD credit recognised under Georgian continuing medical education requirements.

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