Design of a quality management system for a pharmaceutical company

Abstract

This project was carried out in a company that sells and distributes medicines, it is striving to improve the quality of the service, which is why it is aiming to design the quality management system based on the processes approach and compliance with ISO 9001:2015 regulatory requirements. To fulfill the objective, the following activities were carried out: processes mapping, context analysis, risk identification, stakeholder mapping, establishment of quality policy and objectives, and development of a control plan. The results indicate the following key processes: purchases, inventories and sales, strategic prospecting, supply and support; management of human resources, technology and finance. Most influential stakeholders; in the client category, the Instituto Mexicano del Seguro Social, private hospitals and laboratories; in the provider category, PISA laboratory and independent drug distributors, in addition, the scope of the management system, policy and quality objectives were established, as well as a control plan for the system's risk management. Critical risks include not having developed mechanisms for electronic commerce and the lack of a Quality Management System. The countermeasures consider creating and designing an e-commerce store and implementing the Quality management system.