ISO 13485:2016 – Lead Auditor Training (Medical Device Quality Management Systems )
Greetings from Indian Biomedical Skill Consortium (IBSC)!!
Program: ISO 13485:2016 – Lead Auditor Training (Medical Device Quality Management Systems )
Certificate: CQI & IRCA Certified Course
Duration: 5 Days (14th – 18th November 2022)
Location: Dharmshala, Himachal Pradesh

Program Details:
Learning objective
- Understand the operations of a medical devices quality management system based on ISO 13485
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
- Learn how to lead an audit and audit team
- Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
- Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011
Target audience
- Auditors
- Managers or consultants
- Individuals responsible for maintaining conformance with medical devices quality management system requirements
- Technical experts seeking to prepare for a medical devices quality management system audit
- Expert advisors in medical devices quality management
- Working biomedical engineers / medical device professionals are also eligible
Certificate: CQI & IRCA Certified Course
Last Date for Registration: 30th October, 2022
Training Duration: 5 Days (14th – 18th November 2022)
Location: Dharamshala, Himachal Pradesh
Note: Travel & Accommodation By Candidate, Hotel Details Will Be Shared To Registered Participants
For quotation send email to n.nareshkumar@ibsc_amtz.in
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For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: 8897330990
WhatsApp Link: https://wa.me/918897330990
n.nareshkumar@ibsc-amtz.in
