Internal audit is the most reliable tool a laboratory has to confirm that its quality management system works and keeps producing technically valid results for patients and clinicians. ISO 15189:2022 requires every accredited laboratory to audit itself at least once a year, and that audit is only as good as the people who plan and run it.
This three-day course equips participants with practical auditing procedures and a working command of the ISO 15189:2022 requirements. You learn to assess conformity against the standard as it applies to real laboratory operations, identify improvements, report findings professionally and drive corrective action to closure.
The audit skills you build carry over to other accreditation schemes. Laboratories preparing for CAP accreditation use them for the required self-inspection, and hospitals preparing for JCI accreditation use them for mock surveys and tracer-style reviews.
Who this course is for
Medical laboratory scientists, technologists and technicians
Quality managers and quality officers
Laboratory supervisors and section heads
Pathology residents and practising pathologists
Medical laboratory science students and interns
How it is delivered
Competency-based sessions using interactive teaching methods, practical audit exercises and case work. Facilitators are experienced medical laboratory experts who work as practitioners and trainers in the field. Every quarter we run one in-person cohort in Nairobi and one live online cohort, each of 5 to 30 participants.
What you will learn
Understand the principles of auditing and the ISO 15189:2022 requirements
Interpret the requirements to determine conformity in day-to-day laboratory operations
Apply auditing ethics and accurately assess a laboratory's compliance with ISO 15189:2022
Recognise gaps in competence and in the management system, and prioritise them
Plan, conduct and report horizontal, vertical and witness audits
Develop and verify effective corrective action that delivers lasting improvement
Syllabus
Day 1
Introduction and analysis of ISO 15189:2022 requirements
Quality and quality management ethics
Coordinating a management system audit using ISO 15189:2022Including the responsibilities of the Quality Manager and internal auditors
Day 2
Audit preparation: horizontal, vertical and witness audits
Checklist planning
Risk-based auditing
Effective auditing techniques and communication skills
Day 3
Witness and technical audits
Communicating and grading audit outcomes
Writing the summary report
Developing corrective action and verifying its effectiveness
Materials included
Participant guide and training materials
Duration and schedule
Total duration
3 days in person / 4 weeks online
Learning hours
24
Session frequency
In person: 3 consecutive days, 08:00 to 16:00 EAT. Online: 12 two-hour sessions, Mon, Wed and Fri 18:00 to 20:00 EAT, over 4 weeks.
Cohort size
Cohort of 5 to 30 participants
Intake
Sessions
Format and venue
Deadline
Availability
25 Jan to 19 Feb 2027
Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3)
Virtual (live online) Zoom
Until the intake is full
Open
25 to 27 Jan 2027
Mon to Wed, 08:00 to 16:00 EAT (UTC+3)
In-person Nairobi, Kenya
Until the intake is full
Open
19 Apr to 14 May 2027
Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3)
Virtual (live online) Zoom
Until the intake is full
Open
19 to 21 Apr 2027
Mon to Wed, 08:00 to 16:00 EAT (UTC+3)
In-person Nairobi, Kenya
Until the intake is full
Open
19 Jul to 13 Aug 2027
Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3)
Virtual (live online) Zoom
Until the intake is full
Open
19 to 21 Jul 2027
Mon to Wed, 08:00 to 16:00 EAT (UTC+3)
In-person Nairobi, Kenya
Until the intake is full
Open
29 Sep to 29 Oct 2027
Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3)
Virtual (live online) Zoom
Until the intake is full
Open
25 to 27 Oct 2027
Mon to Wed, 08:00 to 16:00 EAT (UTC+3)
In-person Nairobi, Kenya
Until the intake is full
Open
Times are shown in the timezone of the venue. Where your browser can work it out, your local time appears underneath.
Need a different date or your whole team trained? Every course can be delivered in-house or virtually on dates that suit you. Mention this in the notes when you register.
Fees and payment
USD 1,050 per participant
Group and in-house rates on request.
How payment works
We invoice after registration. Pay by bank transfer or M-Pesa at least one week before the course starts. Your place is confirmed once payment is received.
Two tea breaks and buffet lunch each day (in-person sessions)
Certificate of completion
First month of Elmenta Lab Pro mentorship, free
Instructors and certificate
Facilitators are experienced medical laboratory experts who work as practitioners and trainers in the field. Named facilitators are confirmed in the joining instructions.
Certificate
Certificate of completion issued by Elmenta Consulting on successful completion of the training. A certificate of completion records attendance and completion; it is not a professional certification and does not confer laboratory accreditation.
A practical roadmap for medical laboratories in Kenya and East Africa: the nine steps to ISO 15189:2022 accreditation, realistic timelines, where SLIPTA fits and why labs…
Compare in-person, online, in-house, e-learning and mentorship options for laboratory staff training, link them to ISO 15189 competence assessment, and budget for CPD.
Common questions
Do I need prior audit experience?
No. The course starts from first principles and builds up to planning and leading an audit.
Can this course be run at our laboratory?
Yes. In-house delivery for a team is available at any time. Choose the in-house option on the registration form.
Will this help us prepare for a CAP or JCI inspection?
Yes. The planning, evidence gathering and reporting skills are the same ones you need for a CAP self-inspection or a JCI mock survey. Audit criteria in the course come from ISO 15189:2022.
How is payment made?
After you register we send a pro forma invoice. Payment is due at least one week before the course starts, by bank transfer or M-Pesa.
A five-day working course through all the essentials of a laboratory quality management system, from document control and validation to audits, proficiency testing and…