About the Initiative

Improving quality management boosts a laboratory’s overall performance

We launched this project to support laboratories that are eager to know more about quality and biosafety.

Our experience has shown us that implementing an effective quality management system (QMS) enables labs to improve their organization, demonstrate their technical skills and deliver reliable results.

The Mérieux Foundation is a family foundation established in 1967. Its mission is to fight infectious diseases mainly in countries with limited resources, by building local capacities. It therefore works with local stakeholders through numerous projects, including the Quality Initiative.

In France the accreditation of medical biology laboratories is a regulatory obligation, which is not the case everywhere. At national level, some countries do not have accreditation bodies or a policy for implementing a quality program throughout their territory.

For this reason, in 2014, we launched the Quality Initiative to provide support for laboratories wishing to learn more about quality (and biosecurity), and in their accreditation process.

Our experience has shown us that the implementation of an efficient, relevant Quality Management System (QMS) enables laboratories to optimize their organization, to demonstrate their technical skills and to deliver quality results.

What does quality mean?

Quality in clinical laboratories refers to the accuracy, timeliness and reliability of diagnostic testing results.

Establishing a QMS in clinical laboratories means:

  • Developing good laboratory practices with controlled processes and standardize them by written procedures
  • Satisfying stakeholders: meeting the needs of patients, physicians and health authorities
  • Promoting a continuous improvement approach and a quality culture

“In health laboratories the quality assurance is the total process by which the quality of laboratory reports can be guaranteed. This may be summarized as the right result at the right time on the right specimen from the right patient, with result interpretation based on correct reference data and delivered at right price.”

WHO Regional Publication, South-East Asia Series No. 28

How do we implement a quality approach?

We believe in taking an incremental approach to implementing a QMS for laboratories. To promote continuous improvement, we adopt the Plan-Do-Check-Act business method, also known as the Deming circle.

Plan

Set objectives and design actions to reach them. During this planning and general audit phase, assess what needs to be done and prepare to do it.

Do

Implement the action plan. Execute the process and collect data. Develop and conduct training programs.

Check

Assess results to ensure that actions are effective. If needed, develop a new action plan at the end of this phase.

Act

Take corrective and preventive actions. Make all necessary changes or adjustments to rectify ineffective actions. Capitalize on effective practices or actions.

What are the goals of the Quality Initiative?

The Mérieux Foundation has designed the Quality Initiative to meet the following objectives:

  • Support laboratories as they implement a sustainable quality approach
  • Reinforce skills and knowledge on quality management
  • Advise laboratory networks on developing tools and programs

Key figures:

until 2020

4

training workshops
organized

until 2020

790

certifications & attestations
delivered

Since 2014

4

e-learning modules
created

Since the launch of the Quality Initiative

The LQSI Tool:
Improving your step-by-step processes

The Quality Initiative is based on using a step-by-step Laboratory Quality Management System (SMQ) tool: Laboratory Quality Stepwise Implementation (LQSI)

The LQSI tool is available, free of charge, to any laboratory that performs diagnostic testing for clinical or public health purposes.

The LQSI website provides guidance on how to set up a QMS in compliance with ISO 15189. Developed in 2014 by the Royal Tropical Institute for the WHO, it translates the requirements of the standard into concrete actions and helps users develop roadmaps for the development of their QMS.

Access the LQSI tool

“You need to have a clear vision of what you want to implement a quality management system, and, most importantly, commitment from every member of staff.”

Professor Souleymane Diallo
Director, Charles Mérieux Center for Infectious Disease in Bamako (Mali)