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.
Delegates develop knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.
How will I benefit?
- Understand how to implement a QMS as required by medical device directives
- Plan the implementation of ISO13485:2016 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.
Who should attend?
Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.
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 training course.
Delegates will be able 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
Practical information
- It's a 2-day course
- The training and materials will be provided in English
