Training Dates: May 27, 28; June 3, 4  8 a.m. – 12:30 p.m.

Overview:
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 new 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.

Prerequisites:
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.

Register here.