This two-day course will improve the effectiveness of the Quality Management System and help you understand the best practices to conduct an effective internal audit in accordance with the requirements of ISO 13485:2016.
Who should attend?
Individuals needing to conduct an effective QMS audit in accordance with the requirements of ISO 13485:2016 and ISO 91011:2011
What will you learn?
- An overview of the ISO 13485 requirements
- The management systems and internal audits roles
- The roles and responsibilities of an Internal Auditor
- Plan your audits and how to develop the effective checklists
- How to carry out effective audits using LR's 6 Stage Approach
- To gather objective evidence through observation, interviewing and sampling of documents
- To evaluate audit findings and determine conformity, nonconformity and effectiveness
- To report findings accurately, adding value to the business
- What is corrective action and who is responsible for implementation
- How to follow up and verify the effectiveness of corrective action taken
- How to address common internal audit weaknesses within the medical device industry.
What do you need to prepare?
To have successfully completed Introduction to ISO 13485 course.
- Training course materials
- Lunch and refreshments for public attendees only
- Certificate of attendance.