ISO Training Programs
ISO 15189 Internal Auditor Training
Course Objective
The ISO 15189 Internal Auditor Training course equips participants with the knowledge and practical skills required to plan, conduct, report, and follow up internal (first-party) audits of Medical Laboratory Quality Management Systems in accordance with ISO 15189:2022 and ISO 19011 guidelines. The course helps laboratories evaluate quality and competence, identify opportunities for improvement, ensure compliance with international laboratory requirements, and prepare for external accreditation assessments. Hawksberg International provides professional ISO 15189 Internal Auditor Training delivered by experienced industry experts. The programme combines instructor-led sessions, practical laboratory audit exercises, real-world medical laboratory case studies, and interactive discussions to help participants develop the confidence to effectively assess Medical Laboratory Quality Management Systems and successfully perform internal laboratory audits.
Modules covered
Course Details
Duration : 24 Hours
Level : Intermediate
ISO 15189 Internal Auditor Training – Aim
The ISO 15189 Internal Auditor Training equips participants with the knowledge and practical skills required to perform internal audits of Medical Laboratory Quality Management Systems. The course covers ISO 15189:2022 requirements, ISO 19011 auditing principles, laboratory quality management, audit planning, execution, reporting, and continual improvement. Through practical case studies and expert guidance, participants gain the confidence to evaluate laboratory quality systems and prepare organizations for external assessments.
Who Should Attend?
Benefits of Learning ISO 15189 Internal Auditor Training
Improve your knowledge and understanding of the requirements of ISO 15189.
Understand how to apply the requirements of ISO 15189 within your organisation.
Carry out effective internal audits of your laboratory's Quality Management System.
Gain the skills and confidence to challenge management on key quality issues.
Understand the importance of continual improvement and how to implement it in your laboratory.
Improve your communication and audit report-writing skills.
Enhance your career prospects and professional earning potential.
Training Formats
In-House Training — A 2-day (16-hour) programme delivered at your facility and customised to your organisational requirements.
Classroom Training — A 2-day (16-hour) programme conducted at our training facility for classroom-based learning and interaction.
Tutor-Led Virtual Sessions — A 2-day (16-hour) live online programme delivered through Zoom with an expert instructor.
Self-Paced eLearning — 30 days of online access to the ISO 15189 Internal Auditor Course for self-paced learning.
Certification
Participants who successfully complete the course and assessment will receive a Hawksberg International course-completion certificate. A participation certificate is provided to all attendees. For online participants, certificates are issued electronically and sent to the registered email address. The training is delivered by experienced industry experts with extensive practical auditing experience.
ISO 15189 Internal Auditor Training — Frequently Asked Questions
What is the ISO 15189 Internal Auditor course?+
A training course that equips participants to plan and conduct internal (first-party) audits of a Medical (Clinical) Laboratory against ISO 15189:2022 in accordance with ISO 19011.
What does the course cover?+
The course covers ISO 15189:2022 requirements for quality and competence in medical laboratories, pre-examination, examination and post-examination processes, risk management, and how to plan, conduct, report, and follow up an internal medical laboratory audit.
What's the difference between ISO 15189 and ISO 17025 auditing?+
Both standards address laboratory competence. ISO 15189 is specifically designed for medical and clinical laboratories with a focus on patient care, while ISO/IEC 17025 applies to general testing and calibration laboratories.
Who should attend?+
Medical laboratory professionals responsible for internal audits, Quality Managers, Pathologists, Laboratory Technologists, and teams preparing medical laboratories for ISO 15189 accreditation.
Are there prerequisites?+
There are no formal prerequisites. Previous experience in the medical laboratory sector is helpful but not mandatory.