ISO Training Programs
ISO 15189 Lead Auditor Training
Course Overview
ISO 15189 Lead Auditor Training equips professionals with the knowledge and practical skills required to plan, conduct, report, and follow up first-, second-, and third-party audits of Medical Laboratory Quality Management Systems in accordance with ISO 15189:2022 and ISO 19011 guidelines.
Hawksberg International provides professional ISO 15189 Lead Auditor Training delivered by experienced industry experts. The course combines instructor-led sessions, practical laboratory audit exercises, real-world medical laboratory case studies, and interactive discussions to help participants develop the confidence to evaluate laboratory quality systems, ensure compliance with ISO 15189:2022 requirements, and successfully lead medical laboratory audit teams.
Modules Covered
- 01Introduction to ISO 15189:2022
- 02Medical Laboratory Quality Management Systems
- 03General Requirements: Impartiality & Confidentiality
- 04Structural & Governance Requirements
- 05Personnel & Competency Management
- 06Facilities, Equipment & Metrological Traceability
- 07Reagents & Consumables Management
- 08Pre-Examination Processes
- 09Examination Methods & Validation
- 10Measurement Uncertainty & Result Validation
- 11Post-Examination Processes & Reporting
- 12Point-of-Care Testing (POCT)
- 13Management System Requirements
- 14Risk Management & Corrective Actions
- 15Internal Audits & Management Reviews
- 16ISO 19011 Audit Principles
- 17Audit Planning & Preparation
- 18Evidence Collection & Audit Reporting
Course Details
Duration : 40 Hours
Level : Advanced
About the Course
ISO 15189 Lead Auditor Training equips professionals with the knowledge and practical skills required to plan, conduct, report, and follow up first-, second-, and third-party audits of Medical Laboratory Quality Management Systems in accordance with ISO 15189:2022 and ISO 19011 guidelines.
Hawksberg International provides professional ISO 15189 Lead Auditor Training delivered by experienced industry experts. The course combines instructor-led sessions, practical laboratory audit exercises, real-world medical laboratory case studies, and interactive discussions to help participants develop the confidence to evaluate laboratory quality systems, ensure compliance with ISO 15189:2022 requirements, and successfully lead medical laboratory audit teams.
What the ISO 15189 Lead Auditor Course Covers
- ✓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.
Who Should Attend
- ✓Medical Laboratory Professionals
- ✓Laboratory Managers
- ✓Quality Assurance Managers
- ✓Medical Laboratory Staff
- ✓Lead Auditors
- ✓Internal Auditors
- ✓Laboratory Consultants
- ✓Healthcare Quality Professionals
Prerequisites
- ✓A basic understanding of Quality Management Systems.
- ✓Some experience in the medical laboratory sector is helpful.
- ✓Previous auditing knowledge is beneficial but not mandatory.
ISO 15189 Training — Frequently Asked Questions
What is the ISO 15189 Lead Auditor course?
A professional Lead Auditor course delivered by Hawksberg International that equips participants with the knowledge and practical skills to plan, conduct, report, and lead audits of medical (clinical) laboratories against ISO 15189:2022 in accordance with ISO 19011 guidelines.
What does the course cover?
The course covers the ISO 15189:2022 structure, requirements for quality and competence in medical laboratories aligned with ISO/IEC 17025, the pre-examination, examination, and post-examination processes, risk management, and the complete audit lifecycle.
What's the difference between auditing ISO 15189 and ISO/IEC 17025?
Both standards address laboratory competence, but ISO 15189 is specifically designed for medical and clinical laboratories with a focus on patient testing, while ISO/IEC 17025 applies to general testing and calibration laboratories.
What are the prerequisites?
A basic understanding of Quality Management Systems and some experience in the medical laboratory sector is helpful. Previous auditing knowledge is beneficial but not mandatory.
How is the course assessed, and how long is it?
Participants are evaluated through continuous assessment and a final examination. Successful candidates receive a certificate of successful course completion. The course duration is 5 days (40 hours) and is available as Open Classroom, In-House, or Virtual Training.