This online course will help attendees gain complete knowledge of ISO 13485:2016 requirements as well as quality management system implementation in the organizations involved in design, manufacture, storage, distribution, service and commissioning or decommissioning (as applicable) of medical devices. This knowledge can be very useful for those who want to establish, implement, maintain and improve a quality management system in their organization and get it certified for ISO 13485:2016. QMS foundation training course for ISO 13485 has been designed taking into consideration the convenience of attendees. In a short time, this course will satisfy part of the formal training needs of individuals seeking knowledge about QMS requirements, documentation needed for QMS and steps for QMS certification. This course will provide attendees an overall awareness of QMS.
The ISO 13485 QMS Foundation Training – online course contains video tutorials recorded by experienced QMS trainers and handouts in .pdf formats to download as well as online session exams and final exam.
The ISO 13485 training video tutorials on the following topics are given in this course:
For all the above three sessions, the ISO 13485 handouts are given in pdf format. The participant of this ISO 13485 QMS training can download and save the handouts in their computer for future reference and read them offline, anytime and anywhere.
The participant of this online course will be required to clear all session exams and one final exam, which are given as a part of the course. After successfully passing the final exam, his/her auto-generated Certificate will be issued and can be downloaded and printed from the dashboard.
This course is for those requiring an introduction to the ISO 13485 QMS standard, especially those involved in the establishment, implementation and management of a quality management system in medical devices organizations. It has been especially designed keeping in view the needs of:
For details of the authors, trainers and instructors experience and background, please visit our trainers page. They have very rich experience on the subject.
This e-Learning course is provided with study materials and you can read it after your log in or download (PDF format). Use the study materials to reinforce key points and to keep a reminder of what you already learned as well as you can save it in your computer for future reference. The access of this study material is removed after exam is cleared and on line certificate is prepared for the student.
This training program includes the Course Certificate that is issued upon course completion and passing the session exam as well as final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student to get this course certificate
After completing the session and passing each session examination the student can appear for final exam. Once the final exam is cleared then it is considered a end of course. The training certificate is ready on our LMS and student can print it or save the training certificate. It is also available for verification by entering the name and certificate number.