ISO 13485:2016 Clause 4.1 Explained | General Requirements Decode | Live Practical Masterclass

0:00 - Live Stream Welcome, Audio Check & Topic Introduction 08:30 - Masterclass Agenda: ISO 13485:2016 Clause 4.1 Scope 15:00 - Understanding the "Shall" Requirement in Clause 4.1 22:45 - Identifying & Defining Organizational Roles (Manufacturer, Importer, Distributor) 38:15 - Role-Specific Regulatory Requirements & Outsourcing Controls 52:30 - Applying a Risk-Based Approach to QMS Processes (Clause 4.1.2) 1:12:00 - Process Identification, Interaction & Sequence Mapping 1:35:15 - Process Monitoring, Measurement & Performance Indicators (KPIs) 1:55:00 - Managing Changes to QMS Processes (Clause 4.1.4) 2:15:30 - Controlling Outsourced Processes & Quality Agreements (Clause 4.1.5) 2:40:00 - Real-World Audit Scenario: Clause 4.1 Non-Conformances 3:05:00 - Practical Quiz & Case Studies 3:30:00 - Live Audience Q&A, Chat Discussion & Career Guidance 3:50:00 - Key Takeaways, Next Session Topics & Wrap-Up ✨ Subscribe and hit the bell icon to see the latest videos.... Follow Amar on your favorite Social Media Channels: 👉🏻 Facebook:   / amarsbt   👉🏻 Instagram:   / ivd_manufacturing   👉🏻 Linkedin :   / amarsingh385   👉🏻 YouTube:    / @ivdmanufacturing7208   LETS LEARN TOGETHER AND GROW TOGETHER !!!!!!