Description
This module covers the requirements needed for a quality management system (QMS), or quality system (QS), in a medical device company. It looks at the QMS from a (global) regulatory perspective, as well as resources needed, roles, and QMS certification.
Course Objectives
Students completing this course should be able to:
- State how ISO 13485:2003 relates to the medical device industry
- Identify the key areas of and resources needed for the Quality Management System (QMS)
- Identify some key roles in administration of the QMS
- Recognize how the QMS is to be certified by an external auditing authority
Course Outline
INTRODUCTION
1. Welcome
2. Course objectives
3. Assessment
THE STANDARD
4. Why use ISO13485:2003?
5. Applying ISO13485:2003
6. Defining a QMS
7. Review
THE QMS
8. Introduction
9. Key areas of the QMS
10. ISO9000 vs ISO13485
11. Resource management
12. Product realization
13. Planning for product realization
14. Customer-related processes
15. Design & development
16. Purchasing & vendor assurance
17. Production & service provision
18. Control of production processes
ANALYSIS, IMPROVEMENT & DOCUMENTS
19. Measurement & analysis I
20. Measurement & analysis II
21. Measurement & analysis III
22. Improvement
23. QMS documentation
24. Company responsibilities
25. Review I
26. Review II
CERTIFYING THE QMS
27. ISO13485 certification
28. What to expect during an audit
29. Review
CONCLUSION
30. Summary