To successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process.
By the end of the course, participants will understand how to:
- Describe the goals of an internal audit
- State the benefits of internal auditing
- Determine the requirements of an internal audit
- Explain how ISO 13485:2016 differs from ISO 9001 and the areas of focus for Medical Devices.
- Plan an internal audit, and develop a guide list
- Perform an internal audit
- Identify nonconformity to requirements during an audit
- Report on an audit and follow up on corrective actions taken in response to audit findings
- Describe the actions necessary for maintaining a successful audit program
Who Should Attend:
People tasked with conducting Internal Audits of their organization’s ISO 13485:2016 Quality Management System.
There are no prerequisites to attend this training course but a basic understanding of the ISO 13485:2016 Quality Management System standard would be beneficial.
Cost: 2-day class
Location: Location and driving directions will be emailed separately upon registration.