Track: Quality Control and Management

Abstract

Customer satisfaction plays a very significant role in the success of any business. Increased customer satisfaction ensures business continuity. Implementing a Quality Management System (QMS) is one of the ways to improve processes in an organization therefore improving operations and improving the quality of service. Certification through QMS administers the measurement of performance for processes and ensures continuity of the improvements.  ISO 13485 is a standard which represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The standard is in harmony with the ISO 9001, with additional requirements to guide the medical device industry. A questionnaire was administered to the top five customers and employees of small medical devices company.  When questionnaires were analysed, the response received had supported the researcher’s idea, that the implementation of a QMS has a positive effect on customer satisfaction. Through the findings of the study, several gaps were identified from the current operations, and through these gaps, improvement can be implemented utilising QMS principles that have been proven to play a major role in continuous improvement and customer satisfaction over the years as indicated in the literature review of the study