Internal audit on Medical Device QMS – ISO 13485:2016

Successfully conduct an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS

Created by: Stendard Academy
The Stendard Academy

What Will I Learn?

• Conducting an entire internal audit based on ISO 13485:2016 requirements
• General concepts and principles of auditing
• Establishing and preparing for the audit
• Performing the audit (How to conduct a mock audit based on compiled checklist?)
• Reporting the audit results
• Post-audit activities and CAPA planning

Requirements

• Owning the ISO 13485:2016 standard is optional but recommended
• Attending our "Medical Devices Quality Management System - ISO 13485:2016" course is optional, but recommended for beginners
• Familiarising with compiled audit checklist (included in this course resource

Target audience

• Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
• Professionals tasked with overseeing a management system meeting ISO 13485 standards
• Professionals tasked with overseeing an internal audit based on ISO 13485 requirements
• Quality managers
• Risk managers
• Medical device practitioners interested in the ISO 13485 framework
• Anyone who wishes to be able to properly conduct a mock audit independently