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.
CONTENT COVERED IN THE ISO 13485 FOUNDATION TRAINING – ONLINE COURSE
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.
Videos: This part of the training provides online training video tutorials of ISO 13485 clauses requirements, QMS documentation, steps for ISO 13485 QMS certification, etc. All important sessions of this course are covered and delivered by an experienced tutor.
Handouts: For all the above three sessions, the ISO 13485 handouts are given in PDF format. Participants of this ISO 13485 QMS training can download and save the handouts on their computer for future reference and read them offline, anytime and anywhere.
Online Exams: Participants 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, their auto-generated Certificate will be issued and can be downloaded and printed from the dashboard.
COURSE OBJECTIVES
- Familiarize yourself with Medical Devices Quality Management System (QMS).
- Understand the requirements given in each clause of the ISO 13485:2016 standard.
- Familiarize yourself with the QMS documented information.
- Understand the ISO 13485:2016 QMS implementation and steps for quick certification.
WHO CAN ENROLL IN THIS COURSE?
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:
- Company Executives / Managers/ Supervisors/QMS implementers
- Management Representatives
- QMS Consultants
- Management Students
AUTHORS & INSTRUCTORS
For details of the authors, trainers and instructors experience and background, please visit our trainers page. They have very rich experience on the subject.
STUDY MATERIALS
This e-Learning course is provided with study materials and you can read it after you 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 on your computer for future reference. The access to this study material is removed after the exam is cleared and the online certificate is prepared for the student.
EXAMINATION AND COURSE CERTIFICATE
All paid E-learning courses include the Course Certificate that is issued upon course completion and passing the session exams as well as a final exam given in the course with a minimum 60% marks. The option to reappear in the exam is also given to the student, if they fail in any exam.
END OF COURSE INSTRUCTION
After completing the session and passing each session examination the student can appear for the final exam. Once the final exam is cleared then it is considered an end of course. The training certificate is ready on our LMS and students can print it or save the training certificate. It is also available for verification by entering the name and certificate number.
