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 n.nareshkumar@ibsc-amtz.in

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

For more information, please contact

Mr. Nitturi Naresh Kumar

Mobile: 8897330990

WhatsApp Link: https://wa.me/918897330990

n.nareshkumar@ibsc-amtz.in