This course is intended to qualify ISO 13485:2016 auditors to conduct effective audits of an organization’s medical devices.
Understand the requirements of ISO 13485:2016 to be able to conduct a successful audit. The course includes hands-on workshops to prepare you for real-life auditing situations. You’ll learn to manage the audit process and complete reporting.
Learning Objectives:
- Describe the ISO 13485 Medical Device Quality Management System (QMS) – Requirements for Regulatory Purposes standard and development process
- Identify medical device QMS terms
- Describe the intent and requirements of ISO 13485:2016
- Determine the evidence needed to demonstrate conformity to ISO 13485:2016
- Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
- Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
- Apply the principles, processes, and methods of auditing
- Demonstrate the activities involved in preparing for an audit
- Determine an effective audit in the context of the auditee’s organizational situation
- Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit
- Establish and plan the activities of an audit team
- Manage the audit process
- Prepare the audit report and perform an audit follow-up