ISO 13485:2016 Medical Devices Quality Management Implementation Training Course
Course Aim
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.
Course Description
You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.
Who should attend?
- Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
- Management representatives
- Implementation team members
What will you learn?
On completion, you should gain the knowledge and skills to:
- Define a quality management system
- 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
How will you benefit?
This course will help you:
- Understand how to implement a QMS as required by medical device directives
- Plan the implementation of ISO 13485:2016 within your organization
- Take the first steps towards ISO 13485:2016 certification
- Identify how you can better meet regulatory requirements
- Find ways to increase efficiency and add value through quality management
- Monitor supply chains to achieve continuous improvement
Prerequisites
You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction course.
What's included?
- Training course notes for delegates
- Lunch & Refreshments
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate
- Loan copy of the standard (to be returned after the course)