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 : 14 - 15 Mar 2024
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 :
