✓ Certified Course ISO Certification

ISO 15189 Lead Auditor Course (Medical Laboratories)

Become a certified lead auditor for Medical Laboratories aligned with ISO 15189.

Enrol Now View Curriculum
Accreditation
32 Hours (4 Days) Duration
Live Online Format
Certificate On Completion
Enrol Now — $350.00
Course Overview

About this course

This course covers auditing medical laboratory quality and competence against ISO 15189, including pre-examination, examination, and post-examination process controls.
What's Included

Everything you get

✓ Live instructor-led sessions
✓ Downloadable templates and working documents
✓ Full learning management system access
✓ Realistic simulated audit case study
✓ Exam registration handled for you
✓ Digital certificate on successful completion
What You'll Achieve

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

Skills You'll Gain

Practical, job-ready skills

Pre/post-examination process evaluation Quality control auditing Patient safety evaluation Nonconformity writing and grading
Career Outcomes

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.

Curriculum

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
How You'll Learn

Format & delivery

✓ Live virtual instructor-led sessions
✓ One continuous case study audited end-to-end
✓ Choice of intensive or part-time schedule
Assessment & Certification

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.
Is This Course For You?

Who should attend

  • Medical laboratory managers and technologists
  • Pathology quality professionals
  • Internal auditors moving to certification auditing
  • Professionals pursuing medical laboratory lead auditor certification
Answers

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.