Internal Auditor Training on ISO 13485:2016 ‘Medical devices — Quality management systems — Requirements for regulatory purposes’

Date : 2-3 December 2020

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

Link:    Training link will be shared with the registered participants 24 hrs before the program

 

5,000.00

Internal Auditor Training on ISO 13485:2016 ‘Medical devices — Quality management systems — Requirements for regulatory purposes’

Objective 

  • 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 : 2-3 December 2020

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

Faculty :

Mr. Karthi Thiyagarajan : 16+ years of experience in practicing, consulting, training, auditing various Management System. Lead auditor for ISO 13485, AS 9100 Rev D, ISO 9001, IATF 16949, ISO 14001, ISO 45001 and other management system.  

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