1. Brief Description:
The ISO 13485 Medical Devices Quality Management System (QMS) Auditor course is designed to provide participants with the knowledge and skills needed to conduct internal or external audits of an ISO 13485 QMS for medical devices.
2. Key Topics:
- Understanding the ISO 13485 standard and its requirements
- Planning and conducting QMS audits
- Reporting and following up on audit findings
- Understanding the roles and responsibilities of auditors and audit team leaders
- Communicating effectively during audits
- Understanding the audit process and techniques
- Developing corrective actions and improvement plans
This course is intended for individuals who wish to conduct or lead internal or external audits of an ISO 13485 compliant QMS for medical devices. It is also suitable for individuals who seek to become ISO 13485 Lead Auditors.
4. Learning Objectives:
By the end of the course, participants will be able to:
- Understand the purpose and benefits of ISO 13485 standard for QMS in the medical devices industry
- Interpret the requirements of the ISO 13485 standard and apply them to the audit process
- Plan and conduct QMS audits in accordance with ISO 13485 requirements
- Report and follow up on audit findings, and develop corrective actions and improvement plans
- Understand the roles and responsibilities of auditors and audit team leaders
- Communicate effectively during audits
- Prepare for the ISO 13485 Lead Auditor certification exam.