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.