ISO15189 QMS Implementation: Look Before You Leap

The document draws upon lessons learned from QMS implementation at three public National Tuberculosis Reference Laboratories (NTRLs) in Africa, specifically in Botswana, Uganda, and Benin, with expert opinion from international consultants in QMS implementation. The target audience of this guidance document consists of TB laboratory managers, quality officers (QOs), National Tuberculosis Program (NTP) managers, policy makers, and other stakeholders involved in TB laboratory strengthening, primarily in low- and middle-income countries (LMIC) in sub-Saharan Africa, but also in LMIC in regions outside the African continent. Laboratory professionals planning to implement a QMS are advised to take note of the advice provided in this document before initiating the process to determine whether the challenges mentioned are also present in their laboratory and to start efforts to mitigate those that could become obstacles to the efficient QMS implementation process. A mixed-method approach was used to evaluate the QMS implementation projects at the aforementioned NTRLs, including a desk review, a literature review, the collection of quantitative data on laboratory performance, and the collection of qualitative data to identify factors that either propelled the QMS implementation forward or hindered the process. The findings of this evaluation led to the following best practices for the efficient rollout of a QMS in TB laboratories: Laboratory management should ensure funding for the entire QMS implementation process, estimating the amount needed based on identification of the required improvements through a thorough pre-QMS implementation assessment. This assessment should include an evaluation of the laboratory's current processes, resources, and infrastructure to identify areas for improvement and potential challenges. Strong management, leadership, and organizational skills are necessary to facilitate and coordinate the QMS implementation process, ensuring that the change is achieved as efficiently as possible. This includes ensuring that all laboratory staff are involved and committed to the QMS implementation process and that there is a clear understanding of the roles and responsibilities of each staff member. The resources of the laboratory, including personnel, equipment, purchasing and inventory, facilities, and safety, are critical to the QMS implementation process. Laboratory management should ensure that these resources are adequate and that there is a plan in place to address any resource gaps or challenges that may arise during the implementation process. The implementation of a QMS is a big process of change that affects all laboratory processes, and therefore, it is essential to have a clear understanding of the laboratory's current processes and to identify areas for improvement. This includes evaluating the laboratory's current quality management system, identifying any gaps or weaknesses, and developing a plan to address these issues. The Global Health Bureau, Office of Health, Infectious Disease and Nutrition (HIDN), US Agency for International Development, financially supports this publication through TB CARE I under the terms of Agreement No. AID-OAA-A-10-00020. This publication is made possible by the generous support of the American people through the United States Agency for International Development (USAID). The contents are the responsibility of TB CARE I and do not necessarily reflect the views of USAID or the United States Government.