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.