ISO 13485 Medical Devices Foundation
ISO 13485 Medical Devices Foundation
This one day course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulation.
ISO 13485:2016 Medical Devices
Level: Foundation
Course duration: 1 Day
Classroom Based
*Minimum of 4 delegates for In-House Training
Who is it for?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Consultants
Indicative Course Content
History of ISO 13485:2016
Introduction to ISO 13485:2016 & Structure , including the relationship with ISO 9001:2015.
Overview of ISO 13485:2016 requirements
Interested Parties , Documented requirements
Clause 4 Quality management system – The risk-based approach
Clause 5 Management Responsibility – clarification of requirements, planning, responsibility and authority, management representation and management review.
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement
Short Test
Reflection & feedback
