About this course
This course covers auditing medical laboratory quality and competence against ISO 15189, including pre-examination, examination, and post-examination process controls.
Everything you get
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Live instructor-led sessions
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Downloadable templates and working documents
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Full learning management system access
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Realistic simulated audit case study
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Exam registration handled for you
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Digital certificate on successful completion
Learning outcomes
OUTCOME 1
Explain the ISO 15189 requirements for medical laboratory competence
OUTCOME 2
Audit pre-examination, examination and post-examination processes
OUTCOME 3
Plan, conduct, report and follow up a medical laboratory audit
OUTCOME 4
Evaluate patient safety and quality control practices
Practical, job-ready skills
Where this can take you
Step 1
Internal Medical Lab Auditor
Audit your laboratory's quality management system.
Step 2
Medical Laboratory Lead Auditor
Lead accreditation assessments for third-party bodies.
Step 3
Laboratory Director
Oversee lab-wide quality and patient safety.
Course modules
1
Module 1: Medical Laboratory Fundamentals & ISO 15189 Framework
2
Module 2: Audit Principles & Auditor Roles
3
Module 3: Pre/Post-Examination Process Review
4
Module 4: Conducting the Audit
5
Module 5: Auditing Quality Control & Patient Safety
6
Module 6: Nonconformities & Reporting
7
Module 7: Closing Meetings & Corrective Action
Format & delivery
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Live virtual instructor-led sessions
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One continuous case study audited end-to-end
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Choice of intensive or part-time schedule
How you're assessed
Assessment is continuous through in-course activities, plus a final objective examination lasting approximately 1 hour 30 minutes, open book. A certificate is issued shortly after a passing result.
Who should attend
- Medical laboratory managers and technologists
- Pathology quality professionals
- Internal auditors moving to certification auditing
- Professionals pursuing medical laboratory lead auditor certification
Frequently asked questions
What does this course cover? +
ISO 15189 requirements and auditing medical laboratory quality and competence.
Who should attend? +
Medical laboratory managers, technologists, and pathology quality professionals.
How long is the course? +
32 hours over 4 days.
Is this course relevant to pathology labs? +
Yes, it covers medical laboratory quality and patient safety requirements.
What is the exam format? +
Open book, objective questions, approximately 1 hour 30 minutes.