ISO 13485:2016 Internal Auditor Training

ISO 13485:2016 Internal Auditor Training

Course Objective:

  • Understanding of the ISO 13485 Internal Audit requirements
  • Understanding the audit principles
  • Practical skills necessary to plan, conduct, report and close out an internal audit

Course Highlight:

This course provides the required knowledge and skills to carry out an Internal Audit.
This training is based on the ISO 19011:2018 Guidelines for Auditing Management Systems requirements. 
A lot of practical activities would be carry out. 

This course covering the topics indicated below:
  • Overview of Internal Auditing
  • Fundamentals for Auditors
  • Internal Auditor Competency Requirement
  • Understanding of Process Approach & Risk Based Approach in Audit
  • Pre-Audit Preparation (Audit Programme, Audit Plan, Audit Checklist)
  • Conducting the Audit
  • Audit Report Preparation
  • Reporting the Audit and Follow-Up


2 days

Suitable for:

This course is designed for those employees are appointed/potentially appointed as internal auditors, and those who would like to understand the audit process. As internal auditor unable verify their own work, thus, it is recommended that employee from various function and levels to participate in the internal audit.

It is recommended that delegates have the knowledge of the ISO 13485:2016 requirements prior to attend this internal audit training.

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ISO 13485:2016 Internal Auditor Training

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