ISO 13485:2016 Medical Device Management Systems Internal Auditor - Exam
This examination confirms your ability to:
- Interpret and apply the requirements of ISO 13485:2016
- Understand the structure and key clauses of the standard
- Apply risk management principles within quality systems
- Plan, conduct, and report internal audits
- Identify, document, and follow up on nonconformities
- Evaluate effectiveness of corrective and preventive actions (CAPA)
- Apply appropriate audit techniques, including interviewing and evidence collection.
Successful completion demonstrates competency to act as an internal auditor within a medical device quality management system.
This examination is designed for professionals who have completed ISO 13485:2016 Internal Auditor training, including:
- Quality Management Officers (QMOs)
- Internal auditors and audit team members
- Medical device manufacturers and supplier personnel
- Product managers and consultants within the medical device industry.
This examination validates your knowledge and competency in ISO 13485:2016 Medical Device Quality Management Systems and internal auditing practices. ISO 13485:2016 provides a structured framework for ensuring consistent design, production, validation, and risk management processes in the medical device industry.
The exam focuses on evaluating your ability to interpret ISO 13485 requirements and apply auditing principles to ensure compliance with regulatory and customer expectations. A key component of the standard is the integration of risk management throughout the full lifecycle of medical devices, including post-market activities.
This examination is intended for individuals who have previously completed the ISO 13485:2016 Internal Auditor training.
- Validate your knowledge of ISO 13485:2016 requirements and internal auditing practices
- Demonstrate your ability to plan, conduct, and report internal audits effectively
- Strengthen your understanding of risk-based quality management systems
- Improve your organization’s compliance with regulatory and customer requirements
- Enhance professional credibility with a TÜV SÜD Academy Internal Auditor certificate
- Format: Online, proctored examination
- Duration: 60 minutes
- Number of Questions: 25 multiple-choice questions
- Passing Score: Minimum 80%
- Exam Type: Open book (use of ISO standard and class notes permitted)
- Restrictions: Communication with other individuals is strictly prohibited
Candidates must follow all instructions provided by the exam proctor and maintain exam integrity throughout the session.
Online Examination Requirements
Participants must ensure:
- A private, quiet room free from interruptions
- Workspace visible via webcam upon request
- No unauthorized materials present
- No additional electronic devices powered on
- Adequate lighting and clear audio/video connection
- Full compliance with proctor instructions
Failure to comply may result in disqualification or a determination of academic misconduct, including attempted cheating.
Participants are strictly prohibited from copying, reproducing, or distributing exam content.
Upon successful completion, participants will receive the:
“ISO 13485:2016 Medical Device Management Systems Internal Auditor” certificate from TÜV SÜD Academy
Learners must obtain a copyof the ISO standard to be referenced during the course. The standard may bepurchased through the American National Standards Institute (ANSI) (www.ansi.org) and/or American Society for Quality (ASQ) (www.asq.org).
Participants must have successfully completed the ISO 13485:2016 Internal Auditor training course prior to registering for this examination.
This exam is designed as an assessment and assumes prior knowledge of ISO 13485 requirements, audit principles, and internal auditing practices covered during the training program.
What is a proctored exam?
A proctored exam is an assessment supervised in real time by a proctor to ensure fairness and prevent cheating.
What is an online proctored exam?
It is a timed online exam monitored through webcam, audio, and browser activity to ensure exam integrity.
What is a proctor?
A proctor is an individual responsible for supervising exams and ensuring adherence to rules and procedures.
How does the online exam work?
- Candidate identity verification
- Environment inspection via webcam
- Real-time monitoring during the test
- Enforcement of exam rules throughout the session.