This 16-hour class will be delivered in four 4-hour modules Aug 3, 4, 10, 11 from 8:00-12:30
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.