Background: Since disease states are often detected early before any symptoms are evident, the emergence and growing number of molecular diagnostic testing plays a vital role in providing essential information to patients, clinicians and public health policy makers. Quality assurance is an overall quality programme and plays a pivotal role in molecular diagnostics to ensure accurate final test results through standardisation. Even though each laboratory has its own quality assurance process, we cannot determine how effective it is. This paper aims to review the role of quality assurance in molecular diagnostic laboratory. Methods: A systematic qualitative literature review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for evaluating publications relating to quality assurance in molecular diagnostic laboratories. Relevant studies in health-related electronic database such as PubMed, Ovid, EBSCOHOST and Scopus databases from January 2000 to March 2023. Data from included studies were then extracted and the papers’ quality were evaluated using criteria based on Critical Appraisal Skills Programme (CASP) checklist. Results: Fifty-seven articles which were published between 2000 to 2023 were included in this review. Most of the research articles were from cancer studies which has 32 papers. Fifty-one studies were of high quality while six studies were moderate quality. A variety of molecular diagnostic fields, including cancer, infectious diseases, rare inherited diseases, and genetic disorders, have been discussed, including guidelines for conducting molecular diagnostic tests, effectiveness, future challenges, trends, and programmes aimed at improving quality assurance. including policy makers, laboratory experts and scholars should focus on development of suitable quality assurance, addressing constraints, prioritising and ensuring compliance when given the opportunities to accomplish this. Hence, molecular diagnostics laboratories that perform molecular tests in various fields must strengthen and implement quality management.