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Internal Auditor Training - ISO 13485 Management Systems

Continual Improvement

Management Systems

Course Length

16 Hours

Max Attendees


Course Description

Provides hands-on practice using ISO 13485 to evaluate and audit the critical processes of a quality system for the medical device industry. It covers the requirements, an emphasis on regulatory requirements, and key aspects of auditing within a company and for vendors. 

Course Objectives

  • Overview of 13485 requirements
  • Parts of the audit system
  • How to plan and conduct an audit
  • Auditing Techniques
  • Exercises using company’s actual auditing procedure and forms
  • Writing the audit report
  • Preparation for third-party certification
  • Follow-up of Corrective and Preventive Actions
  • 5 mistakes of internal auditors

Course Outline

Who Should Attend:

  • Internal Auditors
  • Quality Managers
  • Managers of Departments who will be audited, such as Purchasing, Manufacturing, and Training
  • Production Supervisors
  • Operators and Technicians