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, CII Members, PWMAI Members & IBSC Partners

Seats: 10 Nos (First cum First service basis) 

Training Duration: 5 Days (16th, 17th, 22nd, 23rd & 24th November 2024)

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

Mode: Online 

Last date for registration 10th November 2024 

 

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. 

For more information, please contact

Mr. Nitturi Naresh Kumar

Mobile: 8897330990

n.nareshkumar@ibsc-amtz.in