ISO 13485: 2016 Online Internal Auditor Training

QMS for Medical Devices | QMS for Medical devicces

Aim of the course

Optimize your internal auditing skills with the internationally recognized ISO I3485:2016 online internal auditor course and boost your internal audit capabilities. Gain confidence in planning and performing an effective internal audit, as well as reporting and taking corrective action where necessary. An ineffective audit can mean severe consequences thus resulting in 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 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits in accordance with ISO 13485:2016. This online internal auditor training 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 13485:2016 and to contribute to their continual improvement.

Who can attend this course?

• Medical device professionals

 • Management representatives/ Top management

• Consultants

 • Those who wish to become internal auditors for ISO 13485

What are the benefits of attending this course?

• 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 through CPD and ensure rigorous regulatory internal processes

 • Write factual audit reports and suggest corrective actions

What is covered?

• Terminologies in standards & PDCA Cycle. •

 Slides carry structure & Overview of 13485 with explanations and examples.

• Planning & Conducting of Internal Audit.

• Writing, reporting and follow up of non-conformities.

• Real time audit non conformity scenario

 • Standard copies

• Delegate course reference materials

 • Online/Email support to clarify quires.

 • Quizzes at the end of module

What prior knowledge should I have?

It is highly recommended that you have prior knowledge of the following concepts: • The Plan-Do-Check-Act (PDCA) Cycle • Basic knowledge of the requirements of ISO 13485: 2016 standards • commonly used terms and definitions


ISO 13485 internal auditor training online course can be completed within thirty days from the date of registration. All successful candidates will be awarded on ISO 13485:2016 Internal Auditor certificate.

Criteria for successful completion

The evaluation of this course will be based on the scores obtained on the minimum of 70% in final exam.

Final Exam

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.

USD 275

Course Duration : 2 Days