Course Objective
The ISO 15189 Internal Auditor Training course enables delegates to plan, conduct, and manage internal (first-party) audits of a medical (clinical) laboratory's quality and competence system within their own organisation, in accordance with ISO 19011, and to help prepare it for external assessment. Delivered through EAS, IAS's sister organisation, by experienced real-time auditors who teach with practical examples, the course leads to a course-completion certificate.
What Does the ISO 15189 Internal Auditor Course Cover?
- Overview of ISO 15189:2022 — requirements for quality and competence in medical laboratories.
- General requirements — impartiality, confidentiality, and requirements regarding patients.
- Structural, governance, and resource requirements — personnel, facilities, equipment, reagents, and consumables.
- Process requirements across the total testing process — pre-examination, examination (including measurement uncertainty and ensuring the validity of results), and post-examination; point-of-care testing (POCT).
- Management system requirements — risk management, internal audit, and management review.
- Auditing guidelines (ISO 19011) — audit definitions, types, and concepts; checklist and report preparation; follow-up procedures; and the roles and responsibilities of an internal auditor.
Who Should Attend?
The course is ideal for beginners who wish to gain auditing knowledge and skills, and is a must for quality managers, management representatives, consultants, and laboratory staff — including medical-lab pathologists, microbiologists, biochemists, and technicians.
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 in your organisation.
- Carry out an effective internal audit 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 report-writing skills.
- Enhance your career prospects and earning potential.
Training Formats
Certification
IAS provides a course-completion certificate for delegates who complete the course, and a participation certificate for all attendees; the soft copy is sent to the registered email for those who attend online. Delivered by experienced real-time auditors with extensive industry background. To learn more, contact us.
