ISO 13485:2016 - Lead Auditor Training Program

ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS)

Admission Open

ISO 13485:2016 – Lead Auditor Training

Medical Device Quality Management Systems

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


Course Outline

  • Overview of quality management systems
  • Scope and definitions
  • Context of the organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance evaluation
  • Improvement
  • ISO 19011:2018 overview and definitions
  • Managing an audit program
  • Performing an audit
  • Competence and evaluation of auditors
  • Additional guidelines for audit planning
  • Case studies on auditing to ISO 13485:2016


Certificate: CQI & IRCA Certified Course 

 Seats: 10 Nos (First cum First service basis) 

Last Date for Registration: 15th April 2023  

Training Duration: 5 Days (24th – 28th April 2023)


Location: Kalam Convention Center, AMTZ Campus, Vizag,  


For quotation send email to

Note: Travel & accommodation by candidate, hotel details will be shared to registered participants 

After receiving confirmation plan your travel. 

If not received minimum number the program may postpone. 


For more information, please contact

Mr. Nitturi Naresh Kumar

Mobile: 8897330990

WhatsApp Link:



Course Fee Information

S.No Start Date End Date Total Amount (INDIA) Total Amount (Foriegn)
1 2023-04-01 2023-04-30 41,300 41,300