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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.

Cost: 2-day class

Location: Location and driving directions will be emailed separately upon registration.

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