Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices. The course introduces the concepts needed to understand, develop, and implement a quality management system.
Participants Receive:-
- Slides including exercises
- ISO 13485:2016 standard
- Certificate of course completion post exam on the 2nd day.
Course Facilitators:-
All course facilitators are highly qualified and experienced both in training and assessment of Medical Devices Quality Management Systems. We strongly believe that the experience in Environment Management Assessment and Training skills is a right combination to deliver a practical training course. They are selected on their ability to make BSCIC courses both practical and enjoyable.
Who should attend?
- Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system
- Management representatives
- Implementation team members
Learning objectives:-
You will learn about:
- Define a ISO 13485:2016 QMS
- Identify the steps for defining, planning, organizing and scheduling necessary activities
- Implement an effective quality management system
- Conduct a base line review of an organization’s current position with regard to ISO 13485:2016.
Eligibility?
Basic knowledge Of ISO 13485:2016 is required.
Course Content and Structure:-
The course of ISO 13485:2016 includes a series of presentations, Examples, Exercises involving group activities, Brain Storming, Case Studies, Readings and Sharing of Practical Experiences.
Duration:-
3 Days