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ISO 13485:2016 Lead Auditor - Medical Devices Quality

This 32-hour training course teaches a detailed understanding of the concepts and requirements of the ISO 13485:2016 Medical Devices Quality Management System standard and the principles and practices of leading management systems audits in accordance with ISO 19011:2018 Guidelines for Auditing Management Systems.

Skills / Knowledge

  • Quality Manager
  • Quality Director
  • Quality Engineer
  • Quality Auditor
  • Regulatory Manager
  • VP of Quality Assurance
  • Regulatory Director
  • Quality and Compliance Manager
  • Director of Quality
  • Vice President of Quality
  • Director of Quality Assurance
  • Quality Specialist
  • Internal Auditor
  • Lead Auditor
  • Principal Auditor
  • Quality Consultant
  • Quality Program Manager
  • Quality Project Manager
  • QC Manager
  • Lab Manager
  • Quality Control Manager

Issued on

September 30, 2024

Expires on

September 30, 2027

Earning Criteria

Required

exam
250 question progressive examination with score of 70% or higher.
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  • SENIOR QUALITY ENGINEER
  • QUALITY ASSURANCE ENGINEER
  • MANUFACTURING QUALITY & CI SPECIALIST