1. Brief Description:
The ISO 13485 Medical Devices Quality Management System (QMS) Implementer course is designed to provide participants with the knowledge and skills required to implement an ISO 13485 compliant QMS for medical devices.
2. Key Topics:
- Understanding the ISO 13485 standard and its requirements
- Developing a QMS implementation plan
- Establishing quality policies, objectives, and procedures
- Documenting the QMS
- Implementing and maintaining QMS processes
- Performing internal audits and management reviews
- Continual improvement of the QMS
3. Audience:
This course is intended for individuals who are involved in the implementation, management, or maintenance of a QMS in the medical devices industry. It is also suitable for those who seek to become ISO 13485 Lead Implementers.
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 a QMS implementation plan
- Develop and implement quality policies, objectives, and procedures
- Document and maintain the QMS
- Perform internal audits and management reviews to ensure the effectiveness of the QMS
- Continuously improve the QMS based on performance metrics and feedback
- Prepare for the ISO 13485 Lead Implementer certification exam.
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