About the Course
ISO 15189 Lead Auditor Training is designed to empower individuals with the skills and knowledge necessary to lead and conduct successful audits in accordance with the ISO 15189 international standard for medical laboratories. In association with our sister organization, Empowering Assurance Systems (EAS), IAS provides this ISO 15189 Lead Auditor Training for candidates interested in auditing medical laboratory quality management systems.
What the ISO 15189 Lead Auditor Course Covers
The course combines the requirements of ISO 15189:2022 with the auditing discipline of ISO 19011, covering:
- The structure of ISO 15189:2022 — requirements for quality and competence in medical laboratories, aligned with ISO/IEC 17025.
- General requirements — impartiality, confidentiality, and requirements regarding patients.
- Structural and governance requirements — legal entity, the laboratory director, and organizational structure.
- Resource requirements — personnel, facilities and environmental conditions, equipment, equipment calibration and metrological traceability, reagents and consumables, and externally provided products and services.
- Process requirements across the total testing process — pre-examination (request, primary sample collection and handling), examination (selection, verification and validation of methods, measurement uncertainty, ensuring the validity of results), and post-examination (reporting, release and storage of results), plus point-of-care testing (POCT).
- Management system requirements — documentation and records, risk management, improvement, corrective action, internal audit, and management review.
- Audit principles and the full audit lifecycle: planning, conducting, gathering evidence, grading nonconformities, reporting, and follow-up.
Key Benefits
Who Should Attend
This program is tailored for professionals involved in medical laboratory management, quality assurance, and those aspiring to become lead auditors. Whether you are from a diagnostic laboratory, healthcare institution, or regulatory body, the course will provide you with the skills needed to ensure compliance and excellence in your organization.
Training Delivery Methods
Delivered over a 5-day (40-hour) program, with the method of delivery you prefer:
Assessment & Certification
Continuous Assessment: candidates are evaluated throughout the course on attendance, active participation, completion of individual and group exercises, and professional engagement during class discussions.
Final Examination: at the end of the course, participants complete a comprehensive examination; passing demonstrates auditing competence.
Certification: participants who successfully complete the training and pass the examination receive a globally recognised certificate of successful course completion. Candidates who do not meet the threshold will be issued a certificate of attendance.
Enrolment Process
Start your professional journey by contacting us about the ISO 15189 Lead Auditor Training today. Visit our frequently asked questions page!
