ISO 13485:2016 MD-QMS Overview Session-1 Part 2
IVD MANUFACTURING
0:00 / 0:00
ISO 13485:2016 MD-QMS Overview Session-1 Part 2
248 просмотров · Трансляция закончилась 2 дн. назад
IVD MANUFACTURING
2,04 тыс. подписчиков
248 просмотров · Трансляция закончилась 2 дн. назад
In This we covered till foundation aspect Clause 4 , 5,6 ,7 ,8 afterbeak
00:00 - Introduction & Stream Welcome
03:00 - Clause 4: Quality Management System & Process Mapping
09:05 - Clause 5: Management Responsibility (Policy & Objectives)
18:30 - Management Review Meeting (MRM) Inputs & Records
20:36 - Clause 6: Resource Management & 4M Framework
21:58 - Clause 7: Product Realization & Lifecycle Controls
23:32 - Clause 8: Measurement, Analysis & Improvement
26:45 - Recap: Practical Implementation of Clauses 6, 7 & 8
30:48 - Monitoring vs. Measurement (Key Differences Explained)
33:55 - Practical Audit Scenario Quiz (Clauses 4 to 8)
39:32 - Quiz Answers & Audit Clause Breakdown
42:27 - Key Takeaways: Process vs. Product Certification & Objective Evidence
46:05 - Live Audience Q&A, Polls & Community Interaction
1:00:00 - Viewer Discussion: Career Paths (Production, Quality & RA)
1:48:40 - Future Session Topic Planning & Closing
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