ISO TRAINING PROGRAMS
ISO 13485 Internal Auditor Training
Course Overview
The ISO 13485 Internal Auditor Course equips participants with the knowledge and practical skills required to conduct internal (first-party) audits of a Medical Device Quality Management System (MDQMS) in accordance with ISO 13485 and ISO 19011 guidelines. The course helps organizations evaluate compliance, identify opportunities for improvement, and prepare for external certification audits. Hawksberg International provides professional ISO 13485 Internal Auditor Training delivered by experienced industry experts. The programme combines instructor-led sessions, practical audit exercises, real-world medical device case studies, and interactive discussions to help participants develop the confidence to effectively plan, conduct, report, and follow up internal Medical Device Quality Management System audits.
Modules covered
Course Details
Duration : 24 Hours
Level : Intermediate
Course Content
The structure of ISO 13485 and its alignment with medical-device regulatory requirements.
Quality Management System and documentation, including the Medical Device File (Clause 4).
Management responsibility and resource management (Clauses 5–6).
Product realization — design and development controls, purchasing, production and service provision, cleanliness and sterile-device requirements, identification and traceability, and validation of processes (Clause 7).
Risk management applied across the Quality Management System, aligned with ISO 14971.
Measurement, analysis and improvement — complaint handling, reporting to regulatory authorities, internal audit, control of nonconforming product, and corrective and preventive action (CAPA) (Clause 8).
The internal audit process based on ISO 19011 — planning, conducting, evidence collection, nonconformity reporting, audit reporting, and follow-up.
Benefits of ISO 13485 Internal Auditor Training
Develops practical skills for conducting ISO 13485 internal audits.
Improves understanding of Medical Device Quality Management System requirements.
Helps evaluate compliance with ISO 13485 and applicable medical-device requirements.
Develops skills in audit planning, evidence collection, reporting, and follow-up.
Strengthens risk-based thinking and internal audit effectiveness.
Supports corrective action and continual improvement activities.
Who Should Attend
QA Engineers
Medical Device Professionals
Quality Assurance Managers
Internal Auditors
Regulatory Affairs Professionals
Medical Device Manufacturers
Frequently Asked Questions
What is the ISO 13485 Internal Auditor course?+
A training course that provides the skills to plan and conduct internal (first-party) audits of an ISO 13485 Medical Device Quality Management System within your own organisation in accordance with ISO 19011.
What does the course cover?+
The course covers ISO 13485 requirements, regulatory and customer requirements for medical devices, risk management, design and development controls, and how to plan, conduct, report, and follow up an internal Medical Device Quality Management System audit.
How is this different from the Lead Auditor course?+
The Internal Auditor course focuses on auditing your own organisation's Medical Device Quality Management System (first-party audits), while the Lead Auditor course prepares participants to lead external, third-party certification audits.
Who should attend?+
Employees responsible for conducting internal Quality Management System audits within medical-device organisations, quality professionals, regulatory staff, and teams preparing for or maintaining ISO 13485 certification.
Are there prerequisites?+
There are no formal prerequisites. A basic understanding of ISO 13485 or Medical Device Quality Management Systems is helpful but not mandatory.
How is the course assessed, and what certificate do I get?+
Assessment is based on participation, course exercises, and a short assessment where applicable. Upon successful completion, participants receive a Hawksberg International course-completion certificate.