ISO 13485-2016 Training Presentation

➡️ Sample File: ➡️ ISO 13485-2016 Training Presentation

➡️ Reach Us For any Query: https://wa.me/917984723501

➡️ Refer to the below details of this Presentation Bundle

• ISO 13485-2016 Training Presentation – 210 Slides
• ISO 13485-2016 Internal Assessment Excel Checklist

➡️ YOU WILL LEARN BELOW THINGS IN THIS PRESENTATION

• Fundamentals of ISO 13485
• ISO 13485 Main Clauses
• Annex A: Comparison of content between ISO 13485:2003 and ISO 13485:2016
• Annex B: Correspondence between ISO 13485:2016 and ISO 9001:2015
• TIPS For Successful Implementation of ISO 13485

➡️ Fundamentals of ISO 13485

• What is ISO 13485?
• Foreword
• Introduction of ISO 13485
• 0.1 General
• 0.2 Clarification of concepts
• 0.3 Process approach
• 0.4 Relationship with ISO 9001
• 0.5 Compatibility with other management systems
• Key Components of ISO 13485
• Objective of ISO 13485
• Who Can Use ISO 13485?
• Key Aspects of ISO 13485
• History of SO 13485
• Why to Implement ISO 13485?
• Key Benefits of ISO 13485 Implementation

➡️ ISO 13485 Main Clauses

1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and Improvement

➡️ ISO 13485 Introduction

• Scope
• Normative Reference
• Terms and Definitions

➡️ Quality Management System

• General requirements
• Documentation requirements

➡️ Management Responsibility

• Management commitment
• Customer focus
• Quality policy
• Planning
• Responsibility, authority and communication
• Management review

➡️ Resource Management

• Provision of resources
• Human resources
• Infrastructure
• Work environment and contamination control

➡️ Product Realization

• Planning of product realization
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of monitoring and measuring equipment

➡️ Measurement, Analysis and Improvement

• General
• Monitoring and measurement
• Control of nonconforming product
• Analysis of data
• Improvement

➡️ Annex A: Comparison of content between ISO 13485:2003 and ISO 13485:2016

• Table A.1: Comparison of content between ISO 13485:2003 and ISO 13485:2016

➡️ Annex B: Correspondence between ISO 13485:2016 and ISO 9001:2015

• Table B.1: Correspondence between ISO 13485:2016 and ISO 9001:2015
• Table B.2: Correspondence between ISO 9001:2015 and ISO 13485:2016

➡️ TIPS For Successful Implementation of ISO 13485