ISO 15189: 2022 Workshop for LQMS implementers within WANETAM

On 25^th October 2024, WANETAM concluded a five-day training for Laboratory Quality Management Systems (LQMS) implementers within the Network.

Organised by the Network’s Laboratory & Quality Assurance Training & Implementation (LAQTI) work package in collaboration with the Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine (MRC Unit The Gambia at LSHTM), the training brought together 18 laboratory and QMS personnel and Biomedical Engineers from 10 countries in West Africa. It was aimed at developing competence and confidence in participants’ understanding and application of the ISO 15189:2022 standard.

Speaking at the opening ceremony, Prof Umberto D’Alessandro, Unit Director at MRC Unit The Gambia at LSHTM highlighted that the training is part of a larger commitment to developing more rigorous systems to support research, building confidence in the data being produced and the capabilities to lead research in West Africa. He recognised WANETAM’s efforts to advancing scientific capacity development across the sub-region. “The Network has been extremely successful in building the capacities of both scientists and staff who support the research being led by scientists across West Africa,” he said.

According to Yai Louise Ndure-Bensouda, WANETAM’s LAQTI lead and Quality Manager at MRC Unit The Gambia at LSHTM, the training is expected to enhance participants’ capacities to support their institutions to achieve accreditation, where it already exists to sustain such accreditation and efficiently support clinical trial and emerging diseases laboratory activities across the sub-region. “It is our hope that participants from institutions that are already accredited or have implemented the standard will return to their institutional laboratories as champions, fully equipped to support the development of institution-specific transition plans from the 2012 to the 2022 ISO15189 standard and implement its requirements. We also expect that participants from institutions that are yet to be accredited, will now serve as resource persons on the standard and contribute to the eventual achievement of accreditation by their institutions,” she said.

Dr. Marc Christian Tahita, a participant from the Clinical Research Unit of Nanoro (CRUN), Burkina Faso highlighted the significance of the training and how it will support his institution’s accreditation. “This training gave us an insight into the new requirements of the 2022 version of ISO 15189 standard, providing us with an understanding of the changes in processes and procedures,” he buttressed.

For Akinlade Kafayat Abosede, a participant from the University College Hospital, Ibadan, Nigeria, highlighted that the training introduced her to vital information that she looks forward to sharing with her colleagues upon her return home through a step-down training. “With my institution planning on transitioning from ISO15189:2012, this training has equipped me with an understanding of the requirements to support our transition and to sustain our accreditation,” she added.

Funded by the European and Developing Countries Clinical Trials Partnership, the training was facilitated by LAQTI work package members based at MRC Unit The Gambia at LSHTM, IRESSEF and IHVN, with support provided by a consultant.

At the end of their training, participants had the opportunity to tour the MRC Unit The Gambia at LSHTM’s Biobank, Molecular Biology Laboratories, Clinical Laboratories and the Archives department, to further understand the Unit’s Quality Management practices.

Following the release of the 4^th edition of the ISO 15189 standard in December 2022 by the International Organization for Standardisation, this workshop is part of WANETAM’s broader efforts to ensure that personnel who work in medical laboratories at its member institutions have knowledge of and can demonstrate competence in its requirements.