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: 20 Nos (First cum First service basis)
Last Date for Registration: 18th January 2023
Training Duration: 5 Days (23rd – 27th January 2023)
Location: Kalam Convention Center, AMTZ Campus, Vizag,
For quotation send email to n.nareshkumar@ibsc-amtz.in
Note: Travel & accommodation by candidate, hotel details will be shared to registered participants
After receiving confirmation plan your travel.
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
| S.No | Start Date | End Date | Total Amount (INDIA) | Total Amount (Foriegn) |
|---|---|---|---|---|
| 1 | 2022-09-30 | 0 | 0 |
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