Understanding the ISO Quality Management System
Many medical devices manufacturing deem QMS as an adversary for their operations, as they have in order to be compliant. However, ensuring an ideal quality management system could pose numerous benefits. It is a set of procedures and policies that companies implement to design, develop, and manufacture their products. In that sense, ISO 13485 quality management system is a widely used standard in medical devices. Implementing this approach allows manufacturers to regulate the safety and integrity of products as per every international regulation. Basic requirements The ISO 13485 quality system is categorized into eight sections of requirements. It is applicable to every design regardless of its type or size. The first three sectors are merely introductory, so companies should focus on other remaining ones. • QMS This fourth section implies general requirements, as well as standards about manual, documentation control, records arrangement, and other essentials. • Management r