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: 5 Nos (First cum First service basis) 

Last Date for Registration: 9th August 2023  

Training Duration: 5 Days (12th, 13th, 18th, 19th & 20th August 2023)

Mode: Online 



For quotation send email to

Note: 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 2023-07-20 2023-08-30 41,300 41,300