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 : 3 - 4 June 2021

Duration : 2 days - 8 hours 

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 

What’s included :

• Learning materials
• Certificate of participation

For any query, please write to :

• Rohit Varshney, Associate QCI , Rohit.varshney@qcin.org, Ph. 9773500376
• Ranvijay Bihari, Dy Director QCI, ranvijay.nabet@qcin.org, Ph. 8800424788
• Alok Jain, Director QCI, ajain@nabl.qcin.org, Ph. 9811352698

Trainers