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 : 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
• • Alok Jain, Director QCI, ajain@nabl.qcin.org, Ph. 9811352698
  • Ranvijay Bihari, Dy Director QCI, ranvijay.nabet@qcin.org, Ph. 8800424788

Trainers

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