Internal Auditor Training On ISO 13485:2016 ‘Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes’


  • To understand and interpret the requirements of ISO 13485:2016 and to develop insights to augment/sustain existing program
  • To gain knowledge to help manage a successful ISO 13485:2016 implementation project
  • To learn how to conduct an effective internal audit based on ISO 13485:2016 requirements

Course Content 

  • Basic Introduction to ISO 13485: 2016
  • Relation of ISO 9001:2015 with ISO 13485:2016
  • Interpret all clauses of ISO 13485:2016 including key issues addressed
  • Identification of applicable regulatory requirements and its compliance
  • Apply principles of ISO 19011 in auditing process
  • Plan, conduct, and report effective internal audits to ISO 13485:2016
  • Case Studies & Role Play

Date : 18-19 March 2021

Duration  : 2 days- 8 hours per day (9.30 am- 5.30 pm)

Target audience

  • Medical Device Manufacturers, Quality Professionals, Regulatory Professionals, Internal and external Auditors, Consultants, and anyone involved with the implementation of the standard

Any other relevant information

  • On successful completion of the training, the participants will be awarded ISO 13485:2016 Internal Auditor Qualification Certificate by TCB, QCI 

    For any query, please write to
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