ISO 13485 : 2016 Medical Devises Quality Management System (MD-QMS) Internal Auditor

Highlights Of The Course:

In this TWO Days course delegates will understand how to audit an effective Medical Devises Quality Management System. You'll learn how to initiate an audit, prepare and conduct audit activities, compile and distribute audit reports and complete follow-up activities. During this training, the participant will acquire the necessary knowledge and skills to proficiently plan and perform internal audit.


Who should attend?

  • Those who audit an organization's processes as part of the internal audit program
  • Wish to be part of quality department in an organization
  • Trainers and consultants
  • Operations personnel
  • Management Representatives

Learning Objectives:

  • Understand the goal, content and correlation between ISO 13485:2003 and ISO 13485:2016
  • To enable delegates understand Key concepts in MD-QMS auditing
  • To impart/enhance practical auditing skills to become certified Internal Auditor
  • To enable the delegates to plan, conduct & manage QMS internal audits in accordance with the principles & guidance of international standard
  • Gain the skills to assess an organization’s capability to manage its MD-QMS
  • Write factual audit reports and suggest corrective actions.

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 IA Certification examination successfully.
  • Introduction to 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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