ISO 13485 Internal Auditor Training
Build expertise in medical device quality management with expert-led ISO 13485 training from DQS Academy.
Our ISO 13485 training is designed to provide practical instruction to help professionals and organizations build the skills needed to support internal compliance and improve their Quality Management Systems (QMS) in line with ISO 13485:2016 requirements.
Course Overview
This ISO 13485 training emphasizes real-world application and internal audit competence.
Participants will learn to:
- Interpret and apply ISO 13485:2016 requirements
- Plan, conduct, report, and follow up on internal audits
- Apply risk-based auditing principles in line with ISO 19011
- Identify nonconformities and improvement opportunities
- Apply learning through practical exercises and case studies
This three-day course is designed for professionals responsible for evaluating, maintaining, or improving medical device quality management systems.
Upon course completion, participants will be able to:
- Apply ISO 13485 requirements in internal audit activities
- Support readiness for regulatory and certification audits
- Identify quality risks before they impact compliance
- Strengthen QMS effectiveness through audit-driven improvement
Audience
This ISO 13485 course is ideal for:
- Internal auditors and quality professionals
- Regulatory affairs and compliance managers
- Quality assurance teams within medical device organizations
- Professionals preparing for external audits or ISO 13485 certification
Instructor
This course is led by Ivan Rodriguez, a Medical Devices Lead Auditor. Ivan brings practical insight into ISO 13485 compliance and internal audit practices, helping participants translate standard requirements into effective, audit-ready organizational processes.
Participant Experience
"I've really enjoyed this training, and it will definitely benefit me in my new role. The instructor explained everything well and made sure to answer questions with as much detail as possible"
— ISO 13485 Internal Auditor Training Participant
Frequently Asked Questions
What is ISO 13485?
ISO 13485 is the international standard for Quality Management Systems (QMS) in the medical device industry, focusing on risk management, regulatory compliance, and lifecycle processes that ensure product safety and effectiveness.
Is prior ISO 13485 knowledge required?
No. The course covers both foundational concepts and internal auditing skills.
Is a certificate provided?
Yes. Participants receive a certificate of completion.
Enroll in the ISO 13485 Internal Auditor Training
To build expertise in Medical Devices Quality Management