ISO 15189:2022 Lead Implementer

Learn to plan, document, implement and maintain an ISO 15189:2022 quality management system that is ready for accreditation.

3 days in person / 4 weeks online (24 hours) In-personVirtual (live online) Next: 11 Jan to 5 Feb 2027 USD 1,050
Laboratory scientist working at a bench

Overview

Level
Open to all experience levels
Delivery format
In-person, Virtual (live online)
Teaching language
English
Duration
3 days in person / 4 weeks online
Prerequisites
None stated

ISO 15189:2022 sets out the quality and competence requirements specific to medical laboratories. It helps laboratories build a quality management system and evaluate their own competence, and it is the standard customers, accreditation bodies and regulators use to recognise that competence. A laboratory that conforms to ISO 15189:2022 shows it is committed to a skilled, quality service across every phase of its operation.

This course guides you through implementation. We explain the ISO 15189:2022 requirements and how to apply them using best international practice. You learn to develop an implementation plan, create the required documentation, monitor the laboratory’s quality management system and achieve continual improvement.

Many laboratories pursue ISO 15189:2022 alongside, or as a step towards, CAP accreditation or JCI hospital accreditation. The quality management system you learn to build here covers the core that all three assess: document control, staff competence, quality control, nonconformity management and continual improvement.

Who this course is for

  • Quality managers and laboratory managers leading an accreditation project
  • Medical laboratory scientists, technologists and technicians
  • Pathology residents and practising pathologists
  • Medical laboratory science students and interns

How it is delivered

Instructor-led training combining presentations, guided practical exercises and web-based tutorials. 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 ISO 15189:2022 requirements for medical laboratories
  • Know the documentation an accredited medical laboratory must hold
  • Understand how the standard is used to assess laboratory competence
  • Create the documents and records that an ISO 15189:2022 QMS needs
  • Build an implementation plan and monitor it through to accreditation

Syllabus

Day 1

  1. Organisation and management
  2. The quality management systemStructure, policies, objectives and documentation

Day 2

  1. Management requirementsDocument control, contracts, referral, complaints, nonconformities and corrective action
  2. Technical requirementsPersonnel, facilities, equipment, pre-examination, examination and post-examination processes

Day 3

  1. Laboratory information systems
  2. Implementation planning and monitoring the QMS

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
IntakeSessionsFormat and venueDeadlineAvailability
11 Jan to 5 Feb 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
18 to 20 Jan 2027 Mon to Wed, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open
5 to 30 Apr 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
12 to 14 Apr 2027 Mon to Wed, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open
5 to 30 Jul 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
12 to 14 Jul 2027 Mon to Wed, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open
27 Sep to 27 Oct 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
12 to 14 Oct 2027 Tue to Thu, 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.

Cancellation and refund terms

The fee includes

  • Facilitation and training materials
  • 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.

Free guides on this topic

Common questions

Should I take this course or the Internal Audit course first?

Take this one first if you are building or upgrading the QMS. Take Internal Audit once the system is in place and needs auditing.

Does the course cover the transition from ISO 15189:2012?

Yes. The changes introduced in the 2022 edition are covered throughout.

Is this course useful if we are aiming for CAP or JCI accreditation?

Yes. An ISO 15189:2022 quality management system covers the core that CAP and JCI assessors look for. The course focuses on ISO 15189:2022 and does not cover each scheme’s checklist item by item.

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.

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