Determining the right size of a Quality Management System (QMS) can make some feel like they are on a roller coaster ride and not know how to navigate the numerous drops and turns. Although developing a QMS is a requirement, it does not need to be overwhelming. Understanding the What, Why, When and How when establishing and implementing a QMS can help break down the requirements and determine the right approach while considering the size and maturity of the business, target market, and product, while focusing on patient safety and customer satisfaction.
MEDIcept Inc. is presenting this paper as an introduction to an upcoming series of papers focuses on Right-Sizing Your QMS discussing QMS implementation, evolution and improvement, and ways to avoid falling out of compliance.