ISO 13485 Internal Auditor Training Online

Aim of ISO 13485 Internal Auditor Training

Learn how to improve your internal auditing skills and enhance your internal audit capabilities with the globally recognized ISO I3485 internal auditor training provided by EAS. Gain confidence in planning and executing an effective internal audit as well as reporting and taking appropriate action where necessary.

An ineffective audit in the medical device manufacturing industry can lead to severe consequences, such as process failure, patient dissatisfaction, and regulatory noncompliance. This online training course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits following the ISO 13485 standard requirements.

The ISO 13485 internal auditor training online course has been designed to give you the necessary skills to perform internal audits in an organization's Quality Management Systems (QMS) for Medical Devices to the requirements of ISO 13485 and to contribute to their continual improvement.

Who Can Attend this Course?

• Medical device manufacturers
• Management representatives / Top management
• Consultants
• Those who wish to become internal auditors for ISO 13485

What are the Benefits of Attending this Course?

• Help your organization maintain compliance with ISO 13485:2016
• Improve a global benchmark in quality standards
• Be confident that your organization can rely on competent auditors
• Motivate colleagues and ensure that internal regulatory protocols are followed
• Write factual audit reports and suggest corrective actions

Course Overview

• Introduction to the ISO 13485 Standard and PDCA Cycle
• Principles of auditing and auditor attributes
• Planning, conducting, and reporting of an internal audit
• Preparing an audit checklist
• Writing, reporting, and follow-up of non-conformities
• Real-time audit non-conformity scenarios

What Prior Knowledge Should I Have?

It is strongly advised that you are familiar with the following concepts:

• The Plan-Do-Check-Act (PDCA) Cycle
• Basic knowledge of the requirements of ISO 13485:2016 standard
• Commonly used ISO terms and definitions

For individuals who are new to ISO standards, it is recommended to take the ISO 13485 foundation course online.

Virtual Learning Mode for ISO 13485 Internal Auditor Training Online

Candidates will learn ISO 13485 internal auditor training online course through a virtual learning mode. The course is a two-day (16-hours) class that will be conducted via Zoom Meeting by our highly trained lead auditors. The course contains the following:

• Interactive Learning Modules with experienced tutors who will guide you through the course
• PowerPoint Presentations
• Group discussions and presentations
• Interactive case studies and role-playing activities
• Training videos with insights on audit perspectives
• Downloadable e-Booklet of Course Material for Off-Line Use
• 24/7 Online Support & Email Service (For queries)
• Online Examination

Final Exam & Certification

The ISO 13485 internal auditor training online course can be completed within thirty days from the date of registration. All successful candidates will be awarded an ISO 13485 Internal Auditor certificate.

The final exam will have 3 sections:

Section A: will contain 10 objective questions carrying one mark each.

Section B: will have 4 short answer questions, each carrying five marks.

Section C: Two audit scenario case studies carrying ten marks each.

Criteria for Successful Completion

The evaluation of this course will be based on the scores obtained on a minimum of 70% in the final exam, which will be taken on the final day of the course. Students who successfully complete this course are automatically eligible to enroll in the ISO 13485 Lead Auditor Course provided by EAS.

To learn more about ISO 13485 Internal Auditor Training Online, please refer to the frequently asked questions.

Ready to enroll? Click here to register for ISO 13485 internal auditor Training online!