The ISO 15189:2012 (Requirements for quality and competence for medical laboratories)

Course Duration: 4 weeks
Delivery Mode: Online
Eligibility: Laboratory staff
Course Availability: Express interest
Course fee per week: $140 – International students $ 99 – Ugandan Students


Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.

The international organisation for standardisation, under its technical committee developed an accreditation standard for medical laboratories, ISO 15189:2015 as a requirement for medical laboratories to exhibit quality and competence in the services they offer. The ministry of health MOH under UNHLS has also adopted the ISO 15189:2012 as the accreditation standard for all its medical public laboratories.

This is a modular course that targets both the managerial and technical requirements of the standard and how they are inter linked with the pre-examination, examination, post examination and support processes in the lab.

Course Aim

This course aims to build the capacity of Laboratory personnel to correctly interpret the managerial and technical requirements of the standard and then utilize the standard to develop, improve and audit Laboratory Quality Management Systems in their Laboratories.


This is a modular course with illustrative learning sessions, videos, live tutorials and discussions.

Module 1

Organisation and Management Requirements

Module 2

Documents and Records Control

Module 3

Services and Supplies

Module 4

Identification and control of Non Conformities

Module 5

Evaluation of the Quality Management System

Module 6

Personnel Management

Module 7

Facilities and safety

Module 8

Equipment and Reagent management

Module 9

Pre- Examination and Examination processes

Module 10

Post Examination Processes

Trainers will include IDI and MoH trainers with expertise in the different areas of the course.

At a glance

4 weeks


Discussion forums

live tutorials



Pass mark

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