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Course Description
An effective internal audit system is a powerful management tool to monitor compliance to the Standard and implement improvement. Auditor skills and behaviour for an effective auditor are discussed and exercised.
Learning Objectives
On completion of the training, participants will be able to:
• Understand the scope and use of ISO 13485 as basis for internal auditing
• Interpret the clauses of ISO 13485 in detail from an internal auditors perspective
• Understand and explain the basics of auditing
• Different types of auditing
• Use the techniques for interviewing and assessing processes
• Prepare and perform an internal audit
• Communicate the results to the auditee and report the results of an internal audit
Examination or testing
During the course cases and exercises are used to verify the gained knowledge and skills. It is also possible to combine the exercises in your own internal audit program.
Program overview
• Environment of ISO 13485 in the Medical Device Industry
• Introduction of ISO 13485 and comparison with ISO 9001
• Process approach
• Comprehensive contents of ISO 13485 (including focus of internal auditor)
• Internal audit process
• Define an audit program
• Auditor skills and behaviour
• Preparing, performing and reporting an audit
• Auditing in practice
• Questions & Answers
• Evaluation of the course and Closing
Who should attend
• Internal and external Auditors
• Quality Managers and Regulatory Affairs Managers
The number of participants is maximized to nine to provide a stimulating and practical working environment.
Level
There is no prerequisite for this course but participants will benefit from a basic knowledge of the quality management systems, ISO 9001, ISO 13485 or 21 CFR 820 QSR.
Duration
2 days, including refreshments, lunches, diner and overnight stay.
Training material
Course notes are provided on a USB stick.
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