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: 05th November 2022
Training Duration: 5 Days (14th – 18th November 2022)
Location: Hyderabad,
Note: Travel & accommodation by candidate, hotel details will be shared to registered participants
For quotation send email to n.nareshkumar@ibsc_amtz.in
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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