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ISO 13485 Awareness/Overview
Workshop Objectives:
- Provide an understanding of the benefits of implementing the ISO 13485 Medical Devices standard.
- Provide an understanding of the ISO 13485 registration process.
- Provide an understanding of the process model approach to the ISO 13485 standard.
- Provide an understanding of the eight quality management principles that form the basis for the ISO 13485 standard.
- Provide an understanding of the fundamental principles, objectives and requirements of the ISO 13485 and ISO 9000 series of standards/guidance documents:
Who Should Attend?
All employees involved in developing, implementing and maintaining a quality management system, including managers, supervisors and staff.
Workshop Outline:
- Introductions
- Workshop Objectives/Outline
- Lecture – Introduction to ISO, Benefits
- Exercise – Benefits
- Lecture – The Registration Process, Process Model
- Break
- Lecture – ISO 13485
- Exercise – ISO 13485
- Lunch
- Exercise Debrief – ISO 13485
- Lecture – ISO 13485
- Workshop Summary
- Evaluation
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