Workshop / Short Course 1:
ISO 15189:2022 Updates: International Quality Standards and Laboratory Accreditation
Instructor: Dr. Ismail Bakhsh & Dr. Soha Tashkandi
Duration 3 hours
Audience: All Medical Laboratory Scientists
- ISO 15189:2022 key changes
- Risk management
- Competence requirements
- Internal audits
- Method verification and validation
- Quality indicators
- Laboratory documentation
- Accreditation readiness
- Case studies
ABSTRACT
ISO 15189:2022 — Medical laboratories: Requirements for quality and competence — represents the most significant revision to the international laboratory quality standard in over two decades. Published in December 2022, the updated standard introduces a new eight-clause High Level Structure (HLS) aligned with ISO/IEC 17025:2017, embedding risk-based thinking throughout the Total Testing Process (TTP) and introducing explicit requirements for impartiality, point-of-care testing (POCT), staff authorization, and verification of performance at clinical decision limits.
This 3-hour course equips medical laboratory scientists with the knowledge and practical tools required to understand, implement, and audit the key changes introduced in ISO 15189:2022. Drawing on ISO open-source guidance documents, IFCC quality indicator frameworks, and real-world data from the Arabian Gulf region — with a specific focus on Kuwait's evolving accreditation landscape — participants explore each major change through structured content, clinical scenarios, and interactive multiple-choice challenges. The course concludes with a gap-analysis tool and accreditation readiness checklist for immediate application in the participant's laboratory.
LEARNING OBJECTIVES
- Identify the 7 major structural and content changes in ISO 15189:2022
- Apply risk-based thinking across pre-, analytical, and post-analytical phases
- Design a compliant competence assessment and staff authorization programme
- Plan and conduct a risk-based internal audit per Clause 8.8
- Perform method verification including measurement uncertainty and clinical decision limits
- Select and monitor quality indicators using the IFCC WG-LEPS framework
- Assess laboratory readiness for ISO 15189:2022 accreditation
- Interpret accreditation data from the Arabian Gulf and Kuwait context
COURSE AGENDA
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Time
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Module
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Key Topics
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13:00–13:30
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Module 1: ISO 15189:2022 Key Changes
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8-clause HLS, impartiality, POCT, clinical decision limits, new terminology
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13:30–14:00
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Module 2: Competence & Authorization
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6 assessment methods, authorization process, CPD, competence records
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14:00–14:30
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Module 3: Risk Management
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TTP risk mapping, FMEA, ALARP, pre/analytical/post-analytical risks
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14:30–15:00
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Module 4: Internal Audits
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Risk-based audit planning, evidence gathering, findings, corrective actions
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15:00–15:30
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Module 5: Method Verification & Validation
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Precision, trueness, MU, clinical decision limits, validation planning
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15:30–16:00
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Module 6: QIs, Documentation & Accreditation
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IFCC QIs, document control, Gulf & Kuwait data, gap analysis checklist
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KEYWORDS
ISO 15189:2022 • Laboratory Accreditation • Quality Management • Risk Management • Competence Assessment • Method Verification • Measurement Uncertainty • Internal Audit • POCT • Quality Indicators • Arabian Gulf • Kuwait • GAC • Total Testing Process
