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

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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