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Duration: 5 days or 40 hours 

This course enables participants to develop the necessary expertise to support an organization in implementing and managing a Medical Devises Quality Management System (QMS) based on ISO 13485:2016. Implementing a framework based on MD-QMS helps your business consistently deliver and drive continual improvement in your products and services. Participants will also gain a thorough understanding of best practices used to implement quality processes based on requirements from ISO 13485. Using a step-by-step approach will allow the delegates to learn how to develop an implementation plan, create necessary documentation, monitor your MD-QMS and achieve continual quality improvement.

Who should attend?

• Management representative
• Anyone involved in the planning, implementing, maintaining or supervision

Learning Objectives:

• Will learn the process for implementing ISO13485:2016
• Will understanding the concepts, approaches, standards, methods and techniques required for the effective management of a MD-Quality Management System
• Implement the key concept and requirement of ISO 13485:2016
• Will gain the knowledge and skills in identifying the risks and opportunities associated with an organization
• Improve the capacity for analysis and decision making in the context of quality management
• Specific documented information requirements as per standard

Agenda:

• Four days intensive classroom ISO TRAINING
• Exclusive access to trainer for after ISO TRAINING query clarification
• In-house certification exam on the last day of the ISO TRAINING
• Prepares participants to take and pass the ISO 13485 LI Certification examination successfully.
• Introduction to Medical Devises Quality Management System (MD-QMS) concepts as required by ISO 13485
• Planning and Initiating an ISO 13485 implementation
• Conducting an ISO 13485 implementer
• Concluding and ensuring the follow-up of an ISO 13485 Implementation

Certificate of attendance will be awarded to all participants