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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

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: 10 Nos (First cum First service basis)
Training Duration: 5 Days (20th, 21st, 25th, 26th & 27th February 2026)
Nationality: Any Nationality
Time: 10:00 AM - 5:00 PM (Indian Standard Time)
Mode: Online (Microsoft Teams Platform)

Last date for registration 25th January 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

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 80 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 INR 41,300 (including GST) and WhatsApp the payment screenshot to 92810 78556 or 8897330990

Course Fee Information
S.No	Start Date	End Date	Total Amount (INDIA)	Total Amount (Foriegn)
1	2026-01-07	2026-03-31	41,300	0

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