RAQ 520 QUALITY MANAGEMENT SYSTEMS
This course is designed to provide students with a comprehensive understanding of the principles and practices of quality management in organizations in the medical technologies industry. The course will cover the various components of a Quality Management System (QMS), including planning, control, assurance, and improvement. The course will cover the regulatory requirements and industry standards for QMS, including ISO 9001, ISO 13485, FDA regulations, risk management, and Good Manufacturing Practices (GMP). Students will learn about the role of QMS in ensuring compliance with these requirements and standards and in achieving organizational goals such as customer satisfaction, continuous improvement, and operational efficiency. Students will be provided with practical examples and case studies to help them apply their learning to real-world situations. Students will gain insights into designing, implementing, and maintaining Quality Management Systems (QMS) to ensure compliance with quality requirements. They will develop a solid understanding of QMS principles and practices, enabling them to design, implement, and maintain QMS in accordance with regulatory requirements and industry standards.