01
Learning Objectives
Acquire skills to conduct audits in medical laboratories according to ISO 15189; understand related standards and guidelines; develop critical analysis and non-conformity identification abilities.
FINAL EXAM ONLY
ISO15189_LA
Auditor/Lead Auditor ISO 15189 (Medical laboratories)
The "Auditor/Lead Auditor ISO 15189 (Medical laboratories)" course is designed to train professionals in performing internal and external audits in compliance with the ISO 15189 standard, specific to medical laboratories. Participants will gain in-depth skills in interpreting and applying quality management and technical competence requirements within diagnostic laboratory settings. Knowledge areas include specimen pathway analysis, risk management, biosafety, data integrity, and accreditation compliance procedures. The course also equips learners with practical tools to plan, conduct, and report audits, emphasizing ISO 19011 guidelines for effective audit processes. Intended for current or aspiring auditors and quality managers in clinical laboratories, the program explores realistic case studies and critical scenarios to prepare attendees for certification. The 60-minute duration offers a focused and efficient learning experience, concluding with an assessment featuring questions based on real professional situations. Passing the final exam ensures robust theoretical knowledge essential for supporting compliance and continuous improvement in healthcare diagnostic facilities.
Exam duration60 min
Pass mark70%
Available questions200
CIWZ PROFESSIONAL ASSESSMENT
High-integrity learning environment
The pathway is designed for managers, executives, function owners, auditors and professionals. Lessons use validated minimum study time and a contextual tutor; assessments use server-side random selection of questions and answers, session-continuity controls, camera and local audio-activity monitoring during protected tests.
Traceability and reliability: integrity events are logged for authorized review; automated signals do not determine the result on their own.
OFFICIAL PATHWAY INFORMATION
Course technical sheet
Purpose, references, delivery method, commercial terms and certificate value, presented clearly and transparently.
02
Competencies Obtained
Audit planning and execution; interpretation of ISO 15189; evaluation of specimen pathways; risk and biosafety management; verification of IT procedures and documentation.
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Target Audience
Healthcare and diagnostic professionals, auditors, quality managers, laboratory technicians, and staff involved in medical laboratory certification.
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Prerequisites
Basic knowledge of laboratory processes and quality management standards; recommended work experience in healthcare settings.
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Course Content
- Introduction to ISO 15189 and ISO 19011
- Structure and requirements of ISO 15189
- Audit planning and conducting
- Specimen handling and risk management
- Biosafety and process validation
- Documentation, reporting, and data integrity
- Non-conformity assessment and management
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Teaching Methodology
Theoretical lessons combined with case studies, real scenario analyses, practical exercises, and audit simulations.
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Assessment Method
Final exam with multiple-choice questions based on practical scenarios; minimum passing score 70%.
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Duration
60 minutes.
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Certification
Certificate of attendance upon passing the exam.
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Expected Outcomes
Ability to perform ISO 15189-compliant audits; identify critical issues in specimen pathways and laboratory management; implement effective corrective actions.