Governance & Document Control for Laboratory Accreditation [LAB-01-EN]

Governance & Document Control for Laboratory Accreditation [LAB-01-EN]

Laboratory accreditation failures are rarely attributable to technical deficiencies alone; surveys conducted under ISO 15189:2022 and Joint Commission International (JCI) standards consistently identify inadequate governance structures and disorganized documentation systems as leading causes of non-conformance findings. In Georgia and across the South Caucasus, the accelerating integration of laboratories into national quality assurance frameworks — including alignment with European Union Good Laboratory Practice directives under the EU–Georgia Association Agreement — has created an urgent demand for quality professionals who can construct and sustain compliant management systems. Poorly controlled documents, undefined roles of authority, and missing version-control trails do not merely jeopardize accreditation status; they introduce patient safety risks by allowing outdated procedures to reach the bench. Mastering the governance and document control requirements embedded in international standards is, therefore, both a regulatory obligation and a direct clinical quality imperative.

This course is grounded in the requirements of ISO 15189:2022, ISO/IEC 17025:2017, and the WHO Laboratory Quality Management System (LQMS) framework, cross-referenced with JCI Laboratory Services Standards to ensure applicability across a range of accreditation pathways. Instruction follows a competency-based methodology: each conceptual module is paired with annotated document templates, real-world non-conformance case analyses, and structured reflection exercises that translate regulatory language into operational practice. Participants engage with authentic Georgian laboratory scenarios — including common documentation gaps identified during Accreditation Service Georgia (ASG) surveys — ensuring that learning is immediately transferable to local institutional contexts.

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

• Distinguish the governance requirements stipulated in ISO 15189:2022 Clause 5 from those in earlier editions, identifying specific structural changes that affect laboratory management responsibilities.
• Design a compliant document hierarchy — encompassing quality manuals, standard operating procedures, work instructions, and records — that satisfies the traceability and accessibility requirements of international accreditation bodies.
• Implement a document life-cycle control system, including version numbering conventions, review schedules, approval authorities, and obsolescence protocols, using tools appropriate for both paper-based and electronic quality management systems.
• Construct an internal audit checklist targeting document control and governance clauses, capable of identifying non-conformances before an external accreditation survey.
• Apply root-cause analysis methods — specifically fishbone and five-why techniques — to documented governance failures, producing corrective action plans that meet ISO 15189 non-conformance management requirements.
• Evaluate an existing laboratory quality management system against a defined evidence matrix, producing a structured gap analysis report with prioritized remediation actions tied to specific standard clauses.

Who Should Attend

This course is designed for laboratory quality managers, accreditation coordinators, and senior medical laboratory scientists who hold or share responsibility for quality system maintenance in clinical, public health, or reference laboratory settings. It is equally valuable for laboratory directors and pathologists assuming governance oversight roles, as well as hospital quality officers who interface with laboratory accreditation processes within multi-departmental healthcare organizations. Professionals at mid-to-senior career stages preparing for an initial ISO 15189 accreditation survey, a surveillance visit, or a system re-design will derive the most direct benefit.

Course Structure

The course is delivered entirely online through GMJ Academy’s asynchronous learning environment, comprising six structured modules with an estimated total study time of eight to ten hours; learners complete a scenario-based summative assessment requiring a minimum score of 75% to qualify for a certificate of completion. Successful participants receive documentation suitable for submission toward Continuing Professional Development (CPD) portfolios recognized under Georgian Medical Chamber requirements.