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

Highlight's of the course:

The FIVE days Lead Auditor training will equip participants with the skills and ability to perform audits by applying widely recognized audit principles, procedures and techniques. Learn to describe the purpose of an ISO 13485:2016 MD-QMS audit and satisfy third-party certification. You’ll acquire the skills to plan, conduct, report and follow up a MD-QMS audit that establishes conformity and enhances overall organizational performance. You will develop auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, open forum discussions with a written examination on your final day.


Who should attend?

  • Those intending to acquire the competence to audit an organization's ISO 13485 based management system, either as third or second party audit.
  • Quality executives/managers,
  • Management representatives,
  • Existing internal auditors
  • Consultants
  • Personnel who wish to pursue career in MD-MS auditing

Learning Objectives:

  • Will learn the Auditing process for ISO13485:2016
  • Will understanding the concepts, approaches, standards, methods and techniques required for the effective management of a Medical Devises 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 of ISO 13485:2016

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 LA Certification examination successfully.
  • Introduction to Medical Devises Quality Management System (MD-QMS) concepts as required by ISO 13485
  • Planning and Initiating an ISO 13485 audit
  • Conducting an ISO 13485 audit
  • Concluding and ensuring the follow-up of an ISO 13485 audit




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