The ISO 13485 course is structured to deliver information in a manner maximizing understanding and retention among students. Throughout our ISO 13485 training, voice narration is utilized, guiding the students through each topic covered with clarity. To make more complex concepts easier to understand a variety of visual aids are used, such as charts and diagrams. Employing a variety of teaching strategies makes our course more engaging and accessible for all students.

To give practical context to the knowledge gained in this course, students will also analyze a number of real-world case studies. With this approach, students will learn how to apply their skills in practical situations. To further reinforce the comprehension of the course material, quizzes are interspersed throughout the ISO 13485 training. This serves as a self-assessment tool for students to find gaps in their knowledge and revisit topics that require reinforcement.

By completing the ISO 13485 course students will gain a deep understanding of the ISO 13485:2016 standard requirements, which focus on quality management systems for medical devices, and earn an ISO 13485 certificate. The students will learn about all facets of the standard, gaining insights into its applications and the significance of maintaining and improving quality in the medical device industry. A key objective of this course is to teach its students the foundational principles of auditing based on ISO 19001:2018 standards. This includes components such as, planning audits, conducting, and reporting, which are essential in ensuring quality management system compliance and effectiveness.

By completing this course and earning the ISO 13485 certificate, students will have the skills necessary to critically evaluate the performance of QMS processes and identify areas that require improvement, ensuring compliance and improving system effectiveness. The students will be ready to conduct comprehensive audits within the medical device industry and make recommendations to enhance quality.

• Introduction
• Terms and Definitions
• Standard Requirements Explained
  • Quality Management System
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis and Improvement
• Principles of Auditing
  • ISO 19011:2018 – Introduction, Scope, Terms and Definitions
  • How to Plan and Conduct Audits
  • Audit Reporting
  • Audit Findings and Follow Up
• Quizzes and Case Studies