ISO 13485:2016 Medical Devises Quality Management System (QMS) Lead Implementer

Highlight's of the course:

This FIVE day intensive 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

Course 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




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