1 Day, 6.5 Instructional Hours
6.5 Engineering Professional Development Hours (PDHs)
Refresh your auditing skills and gain an understanding of how to audit to the new requirements of the standard.
Prerequisites: Registrant must be an ISO 13485:2003 Internal Auditor.
This course is designed for existing ISO 13485:2003 Quality Management System Internal Auditors. Our experienced instructor, will discuss the new requirements, facilitate hands-on exercises, and provide guidance on how to audit to the new ISO 13485:2016 requirements. By attending this one-day course you will be capable of:
- Explain the background for the changes to ISO 13485:2016
- Explain the requirements, and purpose of ISO 13485:2016
- Identifying and understanding the key changes between ISO 13485:2003 and ISO 13485:2016
- Explain how regulatory requirements have been imbedded into ISO 13485:2016
- Understanding how the key changes will impact existing approaches to auditing
- Understanding how to audit to the new requirements of the standard
- Planning an audit program and process-specific audits
- Preparing for the audit by developing effective process diagrams and checklists
- Performing the audits to gather objective evidence through observation, interviewing and sampling of documents and records
- Reporting audit findings accurately to help your organization improve
- Providing exceptional audit documentation
Each participant will receive a training manual and a copy of the ISO 13485:2016 standard.
Who Should Attend:
This course is designed for existing ISO 13485:2003 Internal Auditors.