An Exploratory Qualitative Study on the International Standards Organization Quality Certification in the Health Sciences

Abstract

With the introduction of mandatory ISO certification within the in vitro diagnostic (IVD) industry in South Africa, especially the ISO 13485:2016 quality management system (QMS) for medical devices, it is unclear what contribution ISO certification makes to the South African IVD medical device industry. Moreover, the impact of compulsory ISO certification on the IVD industry in South Africa is also not documented. Thus, this paper reports the findings from an exploratory qualitative study conducted among a probability sample of 10 senior managers of IVD companies. It became evident that most of the participants supported the use of the ISO 9001 certification standard and some companies were certified for up to 10 years. The companies’ leadership also supported iso certification and adopted this quality management system. It was also ascertained that the participants perceived the adoption of the ISO quality management system positively impacted their organizations' performance since customers have greater confidence in the products and the companies.  It is recommended that the Invitro company leadership embrace ISO as a quality management system and ensure that they retain certification since it will impact their performance and enhance customer perceptions of the service and quality.