- Introduction & Course Objectives
- Introduction to ISO 13485:2016
- Structure of the standard
- Contents and purpose of each section
- New Revision: ISO 13485:2016
- Major changes from the previous revision
- Correspondence to and differences between ISO 9001:2015
- CE marking implications
- Conclude & Follow Up Process
Overview of the standard
- Process approach
- Quality management system
- Resource management
- Product realization
- Measurement, Analysis and improvement
Audit Exercise using the standard
- Attendees will break into groups and carry out an audit of a specific area of the facility.
- This will require prior preparation within the facility.
- Afterwards the groups will convene to share experience.
- Responding to an Audit