Establishing and Maintaining a Laboratory QMS

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 management review.

5 days in person / 7 weeks online (40 hours) In-personVirtual (live online) Next: 11 to 15 Jan 2027 USD 1,750
Laboratory sample handling

Overview

Level
Open to all experience levels
Delivery format
In-person, Virtual (live online)
Teaching language
English
Duration
5 days in person / 7 weeks online
Prerequisites
None stated

To meet internal and accreditation standards, laboratory leadership has to establish a quality management system: a system for continuously analysing, improving and re-examining the resources, processes and services of the laboratory. Managing a robust quality programme calls for a wide understanding of resource mobilisation, the processes and outcomes of laboratory medicine, and the accreditation and regulatory requirements that apply.

Building an effective laboratory QMS is hard because the goal, the best possible outcome, is difficult to quantify and often depends on processes outside the laboratory’s direct control. The total testing process, from pre-analytical through analytical to post-analytical, gives a comprehensive working model for evaluating every component of the quality plan as part of the organisation’s wider quality improvement programme. This course works through that model element by element.

A well-run QMS is the foundation for any laboratory accreditation. The quality system essentials covered here are the ones assessed under ISO 15189:2022, the CAP Laboratory Accreditation Program and the JCI laboratory standards, so the course prepares your team whichever route your laboratory takes.

Who this course is for

  • Quality managers and laboratory managers
  • 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, web-based tutorials and group work. Facilitators are seasoned 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

  • Identify the essential components of a laboratory quality management system
  • Assess pre-analytical, analytical and post-analytical processes by monitoring quality indicators
  • Incorporate patient safety goals into the quality management system
  • Determine whether the quality management system is effective
  • Prepare the procedures, records and reviews an accreditation assessor expects to see

Syllabus

Day 1

  1. Development and implementation of a quality management system
  2. New test method validation and verification
  3. Document control
  4. Good documentation practice
  5. Preparation of standard operating procedures and procedure manuals

Day 2

  1. Investigating occurrences
  2. Monitoring the quality control programme
  3. Reagent lot-to-lot validation and verification
  4. Proficiency testing
  5. Quality assurance guide

Day 3

  1. General laboratory safety
  2. Specimen handling and transportation requirements
  3. Laboratory equipment maintenance
  4. Risk assessment
  5. Selection and evaluation of referral laboratories

Day 4

  1. Internal audits
  2. External audits
  3. Continuous quality improvement
  4. Laboratory complaints handling and client satisfaction surveys
  5. Management review

Day 5

  1. Personnel management, training and competency assessment
  2. Laboratory communication
  3. Ethical conduct and professionalism
  4. Privacy, confidentiality and non-disclosure

Materials included

  • Participant guide and training materials

Duration and schedule

Total duration
5 days in person / 7 weeks online
Learning hours
40
Session frequency
In person: 5 consecutive days, 08:00 to 16:00 EAT. Online: 20 two-hour sessions, Mon, Wed and Fri 18:00 to 20:00 EAT, over 7 weeks.
Cohort size
Cohort of 5 to 30 participants
IntakeSessionsFormat and venueDeadlineAvailability
11 to 15 Jan 2027 Mon to Fri, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open
13 Jan to 26 Feb 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
5 to 9 Apr 2027 Mon to Fri, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open
7 Apr to 24 May 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
5 to 9 Jul 2027 Mon to Fri, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open
7 Jul to 20 Aug 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
20 Sep to 8 Nov 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
4 to 8 Oct 2027 Mon to Fri, 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 1,750 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 coffee 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

Is this the right course for a laboratory starting accreditation from scratch?

Yes. It covers every quality system essential a new QMS needs, in the order you would build them.

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.

Does this course help with CAP or JCI accreditation?

Yes. CAP, JCI and ISO 15189:2022 all assess the same quality system essentials, such as document control, competence, quality control and nonconformity management. The course is built around ISO 15189:2022 and does not work through 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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USD 1,750 Register
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