This EASY to understand book is ideal for all (Employees & Employers) and other people who are new to ISO 13485:2016, who want to get more out of an established Quality Management System (QMS). Particularly for employees who just need a basic understanding of what ISO 13485:2016 is and how it applies to them. "EASY ISO 13485:2016" was written so that anyone at any level of the organization can get to the heart of the standard's requirements and how they apply to the organization quickly and simply.