Professional Profile

Name: Malkhaz Babuashvili
Specialization: Medical Laboratory Quality Management Expert | ISO 15189:2022 Consultant | Trainer & Speaker

Medical laboratory quality management specialist with a strong practical focus on ISO 15189:2022 implementation, accreditation readiness, and laboratory quality system development.

Brings over 20+ years of experience across:

  • Biomedical engineering
  • Laboratory quality management
  • Academic teaching
  • Technical services
  • Laboratory systems support

 

Expert in transforming standards and guidelines into:

  • Policies and SOPs
  • Registers and documentation systems
  • Training materials and audit tools
  • Implementation roadmaps and improvement plans

Strong clinical orientation across:

  • Preanalytical, Analytical, Postanalytical phases
  • Risk-based management
  • Method verification & validation
  • Measurement uncertainty
  • Quality control & EQA interpretation
  • Laboratory information systems
  • Management review and continual improvement

Author of a laboratory quality management book and active trainer, lecturer, and conference speaker.

Key Competencies

  • ISO 15189:2022 implementation & gap analysis
  • Internal audit planning, execution, reporting
  • SOPs, policies, forms & registers development
  • Document control & records management
  • Risk & opportunity management
  • Preanalytical quality & phlebotomy systems
  • Method verification & validation
  • Measurement uncertainty & traceability
  • Internal quality control & EQA/PT review
  • Quality indicators & root cause analysis
  • LIS management & data integrity
  • Training, mentoring & technical education

Professional Experience

PROFESSIONAL EXPERIENCE

Medical Laboratory Quality Management Consultant  |  Independent practice / laboratory quality projects  |  [Years]

  • Supports medical laboratories with accreditation readiness, quality management system design, and structured alignment to ISO 15189:2022 requirements.
  • Develops and improves laboratory documentation packages, including policies, standard operating procedures, forms, records, evidence maps, and implementation roadmaps.
  • Performs critical review of laboratory processes across preanalytical, analytical, and postanalytical phases with emphasis on patient safety, compliance, traceability, and measurable improvement.

Trainer, Lecturer, and Conference Speaker  |  Professional education in laboratory medicine and quality management 

  • Designs and delivers lectures, workshops, and presentation materials on ISO 15189:2022, laboratory quality management, safety, method performance, audit readiness, and clinically meaningful use of laboratory results.
  • Transforms complex standard clauses and CLSI guidance into practical training content for laboratory directors, quality managers, analysts, phlebotomy personnel, and multidisciplinary audiences.
  • Develops interactive case-based learning, quizzes, visual teaching materials, and implementation-focused guidance for real laboratory settings.

Consulting Affiliation / Professional Brand  |  Med Tech Inspect LLC  

  • Provides expert laboratory quality support, document-system development, internal audit preparation, and tailored technical mentoring for laboratory organizations.
  • Contributes to professional materials and project work focused on laboratory governance, competence, safety, quality indicators, and sustainable management-system implementation.

SELECTED PROJECTS AND DELIVERABLES

  • Preparation of comprehensive laboratory SOP and policy suites covering document control, risk management, phlebotomy, sample management, internal quality control, information management, downtime, management review, improvement, and purchasing controls.
  • Development of clause-based internal audit guides, evidence request lists, gap analysis reports, and corrective-action frameworks for external audit preparedness.
  • Creation of detailed training modules and presentations on method verification and validation, measurement uncertainty, quality indicators, reference intervals, laboratory safety, and infrastructure requirements.
  • Cross-mapping of ISO 15189:2022 requirements with CLSI quality management guidance to support practical implementation in small and medium-sized medical laboratories.

STANDARDS AND GUIDANCE APPLIED

ISO 15189:2022, ISO 15190:2020, ISO 22367:2020, ISO/TS 20914, ISO 9001:2015, ISO/IEC 27001:2022 Annex A, and CLSI guidance including QMS01, QMS02, QMS06, QMS12, QMS15 QMS16, QMS17, QMS21, QMS22, QMS23, GP17, GP05, M29, AUTO08-A, C24, and relevant EP-series documents for method performance, verification, and analytical quality.

SELECTED TEACHING AND SPEAKING THEMES

  • Modern approaches to laboratory quality management and their clinical significance
  • ISO 15189:2022 as a practical framework for laboratory competence and patient safety
  • Risk-based management of preanalytical, analytical, and postanalytical processes
  • Method verification, method validation, and measurement uncertainty in daily laboratory practice
  • Internal quality control, external quality assessment, and interpretation of performance signals
  • Laboratory safety, infrastructure, and staff competence within a management-system approach

LANGUAGES

  • Georgian — Native or bilingual proficiency
  • English — Professional working proficiency
  • Russion-Fluent

PROFESSIONAL STRENGTHS

  • Ability to convert complex standards into practical, audit-ready documentation and workflows
  • Strong analytical thinking with focus on patient safety, evidence, and sustainable improvement
  • Clear communication style suited to consultancy, teaching, technical writing, and conference delivery
  • Balanced approach combining compliance, clinical relevance, and real-world laboratory practicality

 

LANGUAGES AND ADDITIONAL INFORMATION

  • Languages: Georgian, English, Russian.
  • Digital skills: MS Office, PowerPoint, Outlook, presentations, internet tools.
  • Driver’s license: Category B.
  • Date of birth: 02 September 1980.