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Accreditation of MDQMS (ISO 13485) Certification
Accreditation of MDQMS (ISO 13485) Certification
Agenda
Day 1: Overview of 13485, IAF MD 8 and 9, ISO 13485 Clause 4 (slides)
1. Welcome and Introduction (video) (8:59)
2. General Understanding of Medical Devices & ISO 13485:2016 (video) (80:36)
3. Overview of IAF MD8+9. Management of Impartiality (video) (23:14)
Day 2: ISO 13485 Clauses 5 - 8 (slides)
4. Clause 6 (video) (40:28)
5. Competence of Personnel (video) (34:59)
6. Clause 7 - 7.2 (video) (34:14)
7. Technical Areas (video) (54:48)
8. Clause 7.3 - 7.5 & 8 (video) (39:43)
9. Exercises (video) (8:14)
Day 3: ISO 13485 Clause 9 - 10 and final Q&A (slides)
10. Clause 9.1-9.2. Exercises (video) (38:27)
11. Clause 9 (video) (70:42)
12. Clauses 9.4 - 9.9 (video) (51:40)
13. Clause 10 and wrap-up (video) (12:39)
Workshop exercises
Day 1: Overview of 13485, IAF MD 8 and 9, ISO 13485 Clause 4 (slides)
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