Context
The quality of a laboratory is based on its ability to provide accurate, reliable results at the right time and at the best cost, so that doctors can determine the appropriate treatment for patients.
To achieve this objective, a Quality Management System is essential. This continuous improvement approach involves implementing an organization that ensures laboratory user satisfaction and compliance with requirements.
To help laboratories in resource-limited countries implement this quality management system, the Mérieux Foundation developed the Quality Initiative, aiming to support such organizations in their continuous improvement process with a view to obtaining ISO 15189 accreditation.
Objective
The goal of the project is to support laboratories in setting up quality management systems with a view to obtaining ISO 15189 accreditation. This international standard is specific to medical laboratories, and particularly biomedical laboratories. It includes general and structural requirements, as well as requirements relating to governance, resources, processes, and the management system. By implementing these requirements, the laboratory demonstrates its ability to deliver reliable results for proper patient care.
Activities
The three main areas of focus for the Quality Initiative are:
- Supporting laboratories, most of which are members of the GABRIEL network, in their quality approach.
- Training in management systems, quality, and biosafety in laboratories, through the creation of educational resources, particularly online.
- Advice and expertise for other Mérieux Foundation projects with a quality and/or biosafety component.
The Quality Initiative now has nine partner laboratories, four of which have been accredited/certified.
The project also works on other topics related to quality, such as biosafety (including biosecurity) and laboratory IT (including cybersecurity). By training, assessing, and equipping laboratories, the Quality Initiative promotes working conditions where risks are controlled to protect staff, the environment, and the population.
The Quality Initiative is based on a WHO tool designed to guide laboratories in the gradual implementation of a management system: the LQSI (Laboratory Quality Stepwise Implementation tool). By translating the requirements of the standard into concrete action, it enables laboratories to progress through four phases:
- Phase 1 : Ensuring that the primary process of the laboratory operates correctly and safely
- Phase 2 : Controlling and assuring quality and setting up traceability
- Phase 3 : Ensuring proper management, leadership, and organization
- Phase 4 : Creating continuous improvement and preparing for accreditation
The support offered by the Quality Initiative includes monitoring the action plan through regular quality reviews, providing a budget for process improvement, and a continuing education program.
When the laboratory is ready, the Quality Initiative launches the accreditation process with a national agency or, if the country does not have one, a regional or international agency.
Find out more about the Quality Initiative
Innovative training for all: the Quality MOOC
To meet the growing need for accessible training in quality management, the Mérieux Foundation developed the “Quality Management in Medical Laboratories According to ISO 15189” MOOC. This work was carried out as part of the Quality Initiative in partnership with Afnor and the Institut Pasteur. This MOOC, which stands for Massive Open Online Course, was launched in 2019 and runs annually on the Fun Mooc platform. Lasting six weeks, it allows participants to follow the training at their own pace, with no geographical limitations.
The entire training program was designed by a team of educators to address the fundamentals of quality, culminating in the implementation of a quality management system covering all the processes carried out in a laboratory. Feedback from laboratory staff and quality experts illustrates the theoretical content, providing a practical understanding of how to implement the approach, particularly in countries with limited resources.
Emphasizing interactivity as a key aspect of learning, the MOOC draws on a variety of innovative educational resources and tools, including videos, quizzes, discussion forums, etc.
Every year, the MOOC supports several thousand French-speaking learners from around the world.
Learn more about the Quality MOOC
