ISO 13485 Lead Auditor
ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.
WHO SHOULD DO
- Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits
- Managers or consultants seeking to master a Medical Devices Quality Management System audit process
- 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
EXAM SYLLABUS
- Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
- Audit principles, preparation and launching of an audit
- On-site audit activities
- Closing the audit
- Certification Exam
BENEFITS
- Increase the number of job opportunities
- Create new business connections
- Gain competitive advantage
- Increase effectiveness and lower costs
- Offer expertise on improving work processes
- Offer safer and more efficient medical devices
- Increase customer satisfaction
EXAM INFORMATION
Exam Duration - 3 Hours
Exam Pattern - Descriptive
Exam Method - Paper Based
Exam Pass Mark - 70%
Exam Result - Participant can expect exam result in 2 working days.