1 The System – An Essential Factor For An Organization
2 ISO 9001 – Quality Management System Principles & Key Terms ISO 9001 : 2015 Overview and it’s Connect With Other ISO Management 3 System Standard 4 9K1-15 Key Pillars – Organization Context 5 9K1-15 Key Pillars – Business Risk 6 9K1-15 Key Pillars – Leadership Role 7A Key Concept &Terms - Process Approach 7B Key Concept &Terms – Document N Record 7C Key Concept &Terms – Non-Conformance 7D Key Concept &Terms – Knowledge Management 8 How To Read An ISO Management System Standard Quick Group Exercise Note down one example each for department / function assigned to your group
How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements: A Comprehensive Guide to Designing a Process-Based Document Control System
The ISO 9000 Family of Standards Is Related To Quality Management Systems and Designed To Help Organizations Ensure That They Meet The Needs of Customers and Other Stakeholders