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.
