Project Description


You need this course if you want to understand the best practices to conduct an effective internal QMS audit in accordance with the requirements of ISO 13485:2016 and ISO 19011:2011.


You will learn:

  • an overview of the ISO 13485 requirements
  • the role management systems and internal audits play in helping businesses manage their risks
  • the roles and responsibilities of an Internal Auditor
  • how to plan your audits and how to develop effective checklists
  • to gather objective evidence through observation, interviewing and sampling of documents
  • to evaluate audit findings and determine conformity, nonconformity and effectiveness
  • to prepare value adding reports and present findings accurately
  • what corrective action is and who is responsible for taking action
  • how to follow up and verify the effectiveness of corrective action taken
  • how to address common internal audit weaknesses found within the medical device industry

The course duration will be 2 days and encompasses a class room style, relevant and engaging exercises supported by comprehensive notes.

Book a Training Course for your Medical Device Regulation

For pricing please send us an enquiry by completing the form and we will get in touch with a quotation