PRACTICES AND CHALLENGES OF QUALITY MANAGEMENT SYSTEM (ISO 9001-2008) IN THE PHARMACEUTICAL INDUSTRY: THE CASE OF EPHARM ETHIOPIA

Abstract

Quality is a widely used concept that has become one of the primary agenda in most manufacturing and service providing organizations. Several literature and empirical studies showed that Implementation of ISO based QMS has been proclaimed to have importance in improving quality of products, organizational performance and bringing customer satisfaction. Most of the pharmaceuticals manufactures in Ethiopia are not practicing this system and little or no information is available on what were the benefits obtained and challenges faced by those companies which have undergone the implementation and certifications processes of ISO 9001:2008 QMS. This research basically focuses on trying to get answers to these questions. A descriptive research approach was employed using a self-administered questionnaire to get primary data from employees of EPHARM S.C. These findings are concrete and valuable hence it can be concluded that implementing the system brings the benefits of building the image of company, creating a better competitive advantage on top of its competitors, improved awareness of employees to quality, increased profit and reduced or fewer rejections of products. There has been a reduction in cost of raw materials, effective management system is performed, production volumes have increased and customer orders are shipped on time unlike before. Efforts to determine the challenges of implementing quality management system revealed that lack of adequate information, lack of management commitment and lack of capacity by personnel to be the major challenges that impede the effective implementation of the system. In spite of the few challenges faced by the company to develop, implement and maintain ISO 9001:2008 Quality Management System, broadly asserted benefits of implementing it were found significant as a whole and has resulted in good impact on the performance of the company. This study finally recommends, it is important that all potential problems identified in the implementation of QMS to be given a due attention and appropriate preventive and corrective actions planned ahead during the planning and development stage of the system.