ISO 15189 Training Programs
Welcome to Quality Academy’s ISO 15189 training programs. ISO 15189 is the international standard for medical laboratories, specifying requirements for quality and competence. It applies to medical laboratories involved in patient care and helps ensure accurate and reliable laboratory results. Whether you’re new to medical laboratory management or looking to lead audits within your laboratory, our comprehensive training programs are designed to equip you with the skills and knowledge needed to ensure your laboratory meets the highest standards of quality and competence.
Foundation Course
Target Audience Beginners new to ISO 15189- Medical laboratory staff needing basic understanding- Professionals exploring medical laboratory quality management
Prerequisite None
Course Objective Grasp the fundamentals of ISO 15189- Understand the structure of quality management systems in medical laboratories- Learn the benefits of ISO 15189 certification
Duration 8 hours
Course Content Overview of ISO 15189:2022- Key concepts of medical laboratory quality management- Introduction to risk-based thinking in medical laboratories- Leadership and commitment to quality and competence
Assessment None
Certification Certification of Completion
Ideal For Entry-level medical laboratory professionals- Support staff- Employees needing basic medical laboratory quality management knowledge
Next Steps Progress to Internal Auditor Course
Internal Auditor Course
Target Audience Laboratory quality managers and professionals responsible for internal audits- Managers seeking to assess medical laboratory compliance- Team members tasked with maintaining laboratory quality and competence
Prerequisite Basic understanding of ISO 15189- Completion of Foundation course recommended
Course Objective Learn to plan and conduct internal audits- Understand the auditor’s role in maintaining laboratory quality and competence- Develop skills for reporting and corrective actions
Duration 16 hours
Course Content Audit planning and preparation- Conducting audits and gathering evidence- Reporting non-conformities- Follow-up and corrective actions
Assessment Practical exercises and assessments- In-course assessment of audit skills
Certification Certification of Achievement (CQI and IRCA)
Ideal For Laboratory quality managers- Internal auditors- Team members involved in maintaining laboratory quality and competence
Next Steps Progress to Lead Auditor Course
Lead Auditor Course
Target Audience Experienced auditors aiming to lead ISO 15189 audits- Laboratory managers responsible for audit processes- Consultants involved in ISO 15189 certification
Prerequisite Basic understanding of ISO 15189- Completion of Foundation course recommended
Course Objective Master the audit process from planning to reporting- Lead audit teams in compliance with ISO 19011 and ISO 15189- Manage audit findings and ensure continuous improvement in medical laboratory services
Duration 40 hours
Course Content Detailed ISO 15189:2022 requirements- Managing an audit team- Advanced interviewing techniques- Preparing for certification audits
Assessment Final exam (CQI and IRCA certified)- Practical audit assessment- Continuous evaluation throughout the course
Certification Certification of Achievement (CQI and IRCA)
Ideal For Senior auditors- Laboratory leaders- Consultants and professionals aiming to lead audits in medical laboratories
Next Steps Advanced auditing roles- Consultancy and leadership in medical laboratory management
By choosing Quality Academy’s ISO 15189 training programs, you’re taking a critical step towards ensuring the quality and competence of your medical laboratory services. Whether you’re gaining foundational knowledge, conducting internal audits, or leading audit teams, our expert-led courses will provide you with the essential skills and knowledge to achieve and maintain ISO 15189 certification.
Need help choosing the right course? Contact our team for more information and personalized advice.
