Internal Auditor Training - ISO 13485 Management Systems

Continual Improvement

Management Systems

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