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

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