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ISO 13485 Internal Auditor Training Course

Language : English

Event information
						Location	Price	URL
Online	Online		Register

If you’re part of a medical device company with an established quality management system, chances are you already know internal audits aren’t just a formality. They’re essential to staying compliant, spotting issues early, and making sure your processes actually support what matters, safe, reliable products.

This practical ISO 13485 internal auditor training course is tailored for internal auditors in the medical device industry. It equips participants with the skills to plan, conduct, and report internal audits in line with ISO 13485:2016. Designed for real-world application, the course helps organizations strengthen compliance, improve quality processes, and prepare confidently for external audits.

Target

The goal of this ISO 13485 internal auditor course is to equip participants with the knowledge and practical skills needed to conduct effective internal audits in line with ISO 13485:2016. By the end of the training, participants will be able to assess the performance of a medical device quality management system, identify nonconformities, and contribute to continuous improvement and regulatory readiness.

Agenda

Understanding ISO 13485 structure, intent, regulatory mindset, and core QMS requirements

Applying ISO 13485 requirements to real medical device processes and audit contexts

Developing internal audit competence in a regulated medical device environment

Content

This ISO 13485 internal auditor training course covers the key elements of auditing a quality management system for medical devices. Topics include:

Structure and requirements of ISO 13485:2016
Audit principles and ISO 19011-based methodology
Planning and preparing internal audits
Conducting interviews and collecting evidence
Identifying and documenting nonconformities
Reporting audit results and following up
Auditor roles, responsibilities, and ethics

Interactive exercises and case studies ensure practical, real-world learning tailored to the medical device industry.