Email this article 
Hide
Show all
Review Article
Key success factors for the implementation of quality management systems in developing countries
Submitted: 13 August 2022 | Published: 31 January 2023
About the author(s)
Iryna Tanasiichuk, Department of Modern Technologies of Medical Diagnostics and Treatment, Institute of Postgraduate Education, Bogomolets National Medical University, Kyiv, UkraineOlha Karaman, Laboratory of Oncoimmunology and Design of Tumor Vaccines, R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, National Academy of Sciences of Ukraine, Kyiv, Ukraine
Larysa Natrus, Department of Modern Technologies of Medical Diagnostics and Treatment, Institute of Postgraduate Education, Bogomolets National Medical University, Kyiv, Ukraine
Abstract
Background: Despite the tremendous progress made in advancing laboratory medicine in low- and middle-income countries (LMICs), inadequate quality management systems (QMSs) remain a problem and barrier to provision of reliable laboratory services in resource-limited settings. Therefore, it is useful to study the experience of medical laboratories in LMICs that have successfully implemented QMS.
Aim: This review identified key success factors (KSFs) for medical laboratories in LMICs implementing QMS in accordance with the International Organization for Standardization standard 15189 as a pathway to improving laboratory quality.
Methods: Applying Preferred Reporting Items for Systematic Reviews procedures, we conducted a targeted search of studies from LMICs published between 2012 and 2022 to identify KSFs. Thirty-two out of 952 references retrieved were considered relevant and included in this review. Grounded theory was used to extract key features of the included studies to derive KSFs.
Results: Ten KSFs for medical laboratories striving to implement QMS were identified and described. These KSFs were integrated to create a model of success for laboratory QMS implementation. The model consists of three underlying factors, namely preparing for change, resource availability, and effective project management, each comprising three separate KSFs. Institutional commitment was identified as the core of the model and is integral to ensuring the quality of laboratory services.
Conclusion: Laboratories planning to implement a QMS can benefit from understanding the KSFs demonstrated in this study as this would help them to identify the necessary changes to implement and set realistic expectations about the outcomes of QMS implementation.
Keywords
Sustainable Development Goal
Metrics
Total abstract views: 4898Total article views: 11417
Crossref Citations
1. Food Safety in the Catering Sector: Nonconformities, Challenges, and Strategic Interventions With Insights From South Asia and Africa
Anwar Ali, Aleena Tahir, Nazir Ahmad, Joanna Trafialek, Basim M. Alohali, Isam A. Mohamed Ahmed, Muhammad Faisal Manzoor, Felix Kwashie Madilo
Food Science & Nutrition vol: 14 issue: 1 year: 2026
doi: 10.1002/fsn3.71400
2. Quality Culture for Preventing Technical Risk in Building Apartment Construction Project
Grace Febiola Parura, Mulia Pamadi, Indrastuti Indrastuti
Civil and Sustainable Urban Engineering vol: 6 issue: 1 first page: 86 year: 2026
doi: 10.53623/csue.v6i1.949
3. Harmonization of four biomarkers across nine nationally representative studies of older persons
Peifeng Hu, Eileen M. Crimmins, Jung Ki Kim, Alan Potter, Jake Cofferen, Sharon Merkin, Heather McCreath, Teresa Seeman
American Journal of Human Biology vol: 36 issue: 5 year: 2024
doi: 10.1002/ajhb.24030
4. The impact of quality assurance initiatives on the performance of private higher education institutions in Oman: the mediating roles of quality culture
Hairuddin Mohd Ali, Khadija Ali Mohamed Al Salami
Quality in Higher Education vol: 31 issue: 2 first page: 165 year: 2025
doi: 10.1080/13538322.2025.2542647
5. Laboratory Surveillance, Quality Management, and Its Role in Addressing Antimicrobial Resistance in Africa: A Narrative Review
Khalid Musa, Ijeoma Okoliegbe, Tassabeeh Abdalaziz, Ahmed Taha Aboushady, John Stelling, Ian M. Gould
Antibiotics vol: 12 issue: 8 first page: 1313 year: 2023
doi: 10.3390/antibiotics12081313
6. Policy brief mitigating postharvest losses in the high seas: strategic interventions for sustainable tuna fisheries
Ulysses Montojo, Gezelle Tadifa, Marites Chiuco, Joeren Yleaña, Isidro Tanangonan, Riza Jane Banicod
Frontiers in Marine Science vol: 12 year: 2025
doi: 10.3389/fmars.2025.1602869
7. Implementing and Transitioning a Laboratory Quality Management System from ISO 15189:2012 to ISO 15189:2022: Experience from the Malawi-Liverpool Wellcome Research Programme, Blantyre
Dumizulu Tembo, Joshua S Kaphika, Ajisa Ahmadu, Lovemore Alufandika, Vincent Kalilangwe, Christopher Kukacha, Dumisani Kaphika, Funny T Lipenga, Mirriam Machonjo, Sekani Manda, Mazuba Masina, Emmanuel C Mchoma, Alice C Mnyanga, Innocent M Moyo, Fatsani P Mutala, Patrick Mzumara, Doris Shani, George P Selemani, Brigitte Denis
Wellcome Open Research vol: 11 first page: 144 year: 2026
doi: 10.12688/wellcomeopenres.25356.1
8. Implementing and Transitioning a Laboratory Quality Management System from ISO 15189:2012 to ISO 15189:2022: Experience from the Malawi-Liverpool Wellcome Research Programme, Blantyre
Dumizulu Tembo, Joshua S Kaphika, Ajisa Ahmadu, Lovemore Alufandika, Vincent Kalilangwe, Christopher Kukacha, Dumisani Kaphika, Funny T Lipenga, Mirriam Machonjo, Sekani Manda, Mazuba Masina, Emmanuel C Mchoma, Alice C Mnyanga, Innocent M Moyo, Fatsani P Mutala, Patrick Mzumara, Doris Shani, George P Selemani, Brigitte Denis
Wellcome Open Research vol: 11 first page: 144 year: 2026
doi: 10.12688/wellcomeopenres.25356.2