Admission Open

ISO 13485:2016 – Lead Auditor Training

Medical Device Quality Management Systems

Certificate: Exemplar Global Accredited Course 

For quotation send email to n.nareshkumar@ibsc-amtz.in

Discount available to AMTZ Manufactures; AiMeD Members, UdaiMeD Members, ASSOCHAM Members, CII Members, PWMAI Members & IBSC Partners

Seats: 7 Nos (First cum First service basis) 

Training Duration: 5 Days (19th, 20th, 21st, 26th & 27th September 2025)

Nationality: Any Nationality

Time: 10:00 AM - 5:00 PM (Indian Standard Time) 

Mode: Online (Microsoft Teams Platform) 

Last date for registration 30th August 2025

 

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

 

Note: If not received minimum number the program may postpone. 

Please note that once the fee is paid, it is non-refundable under any circumstances. Candidates are advised to carefully review all details before making the payment.  

Till date about 77 candidates were Certified in ISO 13485 MDQMS 

For more information, please contact

Mr. Nitturi Naresh Kumar

Mobile: 92810 78556 / 8897330990

n.nareshkumar@ibsc-amtz.in 

For payment scan this QR code and pay and WhatsApp the payment screenshot to 92810 78556 or 8897330990