MIM-108    ISO 9001:2015 & ISO 13485:2016 Integrated Management System
                     Internal Auditor Training

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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ISO 13485 Internal Auditor training equips participants with the essential skills to assess and verify the effectiveness of a medical device manufacturer’s quality management system. Auditors are expected to understand both the structure and specific regulatory focus of ISO 13485, including risk management, design controls, sterile manufacturing, and traceability. This standard requires a deeper awareness of product lifecycle and regulatory compliance compared to general quality systems.

An internal auditor plays a crucial role in identifying gaps and ensuring continuous improvement within the organisation. The role goes beyond checklist auditing — it involves evaluating how well processes meet the intended outcomes and regulatory obligations, especially in relation to patient safety and product performance.

Through practical training, internal auditors learn how to plan, conduct, report, and follow up on audits. They develop effective questioning techniques, apply process-based auditing approaches, and write findings that are clear, traceable, and aligned with ISO 13485 clauses. Ultimately, they contribute directly to the organisation’s readiness for external audits and compliance with regulatory bodies.
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Internal auditing is a monitoring and measuring the effectiveness of IMS implementation. The effectiveness of internal audit very much depends on the competency, knowledge and application auditing techniques of the internal auditor. This course apply the process approach auditing skill to enable the participant to learn and understanding the internal auditing principles and techniques.

• To understand the principle and concept of internal audit for ISO 9001:2015 & ISO 13485:2016
• To understand how to plan an audit
• To understand how to prepare audit checklist 
• To understand how to write audit report
• To understand how to conduct corrective action and follow up

• Section 1: Sharp Recap of ISO 9001:2015 Key Clauses
• Section 2: Zooming into ISO 13485:2016 Specifics
• Section 3: Introduction to Audit
  
• Section 4: Systematic Approach to Conducting Audit
  
• Section 5:  Audit Process in Action
  
• Section 6: Audit Reporting
  
• Section 7: Audit Reply & Follow-Up
  
• Live Audit Activity: Hands-on Internal Audit Execution
  
• Audit Reporting & Follow-Up Discussion
  

Note: The "hands-on" auditing practices can focus on the organizations own process and may replace the exercises.

The ISO 9001:2015 & ISO 13485:2016 internal auditor course is essential for any involved in the planning, implementing, maintaining or auditing of an ISO 9001 & ISO 13485 Quality Management System (QMS) in any industry.

This is a ​2-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.