Internal Auditor ISO 13485:2016


Course Overview

Would you like to know what a Notified Body Auditor is looking for when they audit you against the 2016 versions of ISO 13485?


Well, look no further. Our trainers trained the Notified Bodies.

Our two day internal auditor training course focuses on the application of key principles and practices in accordance with ISO 13485:2016 and ISO ISO 19011:2018 “Guidelines for auditing management systems”.  

Our expert tutors will give you the necessary skills to perform internal audits on an organisation’s Quality Management System (QMS) to the requirements of ISO 13485:2016. You will gain the necessary auditing skills through a balance of classroom tutorials and group workshops.


Course Agenda

▪    Practical use of ISO 13485:2016

▪    Principles of auditing, the cycle and objectives

▪    Auditing skills and techniques

▪    Planning - Checklists, resources and timing

▪    Selection of audit teams and training

▪    Evaluation of information and findings

▪    Observation/Opportunities for Improvements 

▪    Evaluating the significance of nonconformities

▪    Communicating and presenting audit reports

▪    Corrective actions and follow-up programmes

▪    Improvements – planning, monitoring and results

Day 1: 8:30am - 16:30pm

Day 2: 9:00am - 16:30pm

The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.

Learning Style

This is a classroom based course filled with practical and interactive activities to embed your learning. 

Who should attend?

This Internal Auditor training course has great value for anyone involved in implementing or maintaining a QMS.

▪    Quality Assurance professionals

▪    Quality Engineers

▪    Research and Design Engineers

▪    Internal Auditors

▪    Quality Managers

▪    Manufacturing Engineers

▪    Regulatory professionals

What will I receive?

▪    Lunch

▪    Refreshments 

▪    Training course notes, slides and handouts 

▪    Internal Auditor training course certificate 

Our team Is on hand to support you with any B&B bookings if required. 

On-site Training

Any of our courses can be delivered on-site at your premises. 

Contact us today to find out more.