The Impact Of The International Standards Organization Quality Management System On The In Vitro Diagnostics Industry In South Africa

Abstract

Quality is an important subject in the modern business world and Total Quality Management (TQM) and the ISO-based Quality Management System (QMS) have been the most common approaches to quality management by organizations. This paper assesses customer service, operational performance, quality, competitive advantage and benefits obtained through ISO certification of IVD products. Five hypotheses were tested through a survey conducted among a random probability sample of 337 employees of IVD companies in South Africa, using the online platform, Survey Monkey.

The findings revealed that top management’s commitment has a strong positive effect on the adoption of ISO certification in the IVD industry and ISO certification has a positive and strong effect on product quality performance, customer service satisfaction focus as well as organisational performance. Based on the research findings, it is recommended that top management of IVD companies should be committed to the adoption of ISO certification and use it as a strategic tool to influence product quality performance, customer service satisfaction focus and organisational performance in the IVD industry.