This course contains the use of artificial intelligence.

Master ISO 15189:2022 Medical Laboratory Accreditation with Clause-by-Clause Auditing, Practical Case Studies, Nonconformities, AI-Assisted Auditing Tools & Lead Auditor Exam Preparation

This ISO 15189:2022 Lead Auditor Certification Course is an advanced, accreditation-focused training program designed to develop competent Lead Auditors for Medical Laboratories in accordance with the latest requirements of ISO 15189:2022, published by the International Organization for Standardization.

The course delivers a clause-by-clause interpretation of ISO 15189:2022, covering management requirements, technical requirements, and the full accreditation lifecycle—from application to surveillance and reassessment. It integrates real-world audit scenarios, nonconformity analysis, and hands-on audit simulations across clinical chemistry, hematology, microbiology, and pathology laboratories.

A key strength of this program is the practical integration of Artificial Intelligence (AI) in laboratory quality management and auditing. Learners will explore how AI tools can support:

• Risk-based audit planning

• Trend analysis of QC and EQA data

• Identification of systemic nonconformities

• Data integrity and LIS oversight

• Decision-making during audits

Risk-based audit planning

Trend analysis of QC and EQA data

Identification of systemic nonconformities

Data integrity and LIS oversight

Decision-making during audits

By the end of the course, participants will be fully prepared to plan, lead, conduct, report, and close ISO 15189 audits, and confidently pursue Lead Auditor certification pathways (IRCA / Exemplar Global aligned knowledge).

This course is developed and delivered by ISO Xpert, a professional training and consulting platform dedicated to ISO standards, accreditation, auditing excellence, and capacity building. ISO Xpert combines deep subject-matter expertise with practical industry experience and modern learning approaches—including AI-enabled tools—to empower professionals worldwide to achieve compliance, competence, and continuous improvement with confidence.