- Easy to access online course
- Learn at your own pace, on a date and time to suit you
- Support from a dedicated e-learning team
Medical Devices
ISO 13485:2016 Internal Auditor Course QMS
★★★★★ 4.4/5
This course teaches delegates the knowledge and skills required to conduct an internal audit of part of a Quality Management System (QMS) against ISO 13485:2016.
During this ISO 13485 Internal Auditor training course, the tutor will lead informative sessions alongside interactive exercises, which help to facilitate a fun and engaging learning environment.
We offer ISO 13485 Internal Auditor training online in a virtual classroom or you can attend a course at one of our UK venues. Alternatively, we can visit your workplace to deliver ISO 13485 team training.
2 day course – 08:45-17:30
CQI and IRCA training level – Practitioner
CQI and IRCA ref – PT247
(ATP No. 1731)
Online Training
Public Training
- For bookings of 1-3 people
- Choose from a timetable of scheduled course dates throughout the year
- Attend the course at one of our UK training venues, or in a live virtual classroom
From 995 pp + VAT
In-House Training
- For a team of 4-10 people
- Dedicated training on a date, time and location to suit you
- We can come to any workplace in the UK or overseas, or we can teach via a live virtual classroom
From 395 pp + VAT
Batalas has been delivering ISO training for over 60 years
We are proud to have a 98% pass rate for this course (data source CQI IRCA)
‘Book now, pay later’ for public training at one of our venues or in a virtual classroom (t&cs apply)
Who should attend this ISO 13485 Internal Auditor Course?
- New or existing auditors who want to conduct internal audits of a quality management system (QMS) that conforms to ISO 13485:2016
- Anyone involved in planning or managing an ISO 13485:2016 quality management system.
- People who are implementing an ISO 13485 QMS.
- Anyone who needs to identify potential gaps in an ISO 13485:2016 quality management system – which in turn will help the organisation remain compliant.
- This course satisfies the training requirement for those who wish to register as an Auditor with the IRCA (International Register of Certified Auditors)
Anyone new to ISO 13485:2016 would benefit from gaining knowledge of the Standard before attending this Internal Auditor course. This prior knowledge can be achieved via our ISO 13485 Foundation course. Both courses are in our COURSE BUNDLE offer, whereby a £50 discount will automatically be applied to the online shopping basket when the courses are added.
What will delegates learn on this ISO 13485 Internal Auditor Course?
On this CQI and IRCA-certified ISO 13485 course, delegates will learn the following knowledge and skills –
- The purpose of a Quality Management System based on ISO 13485:2016 medical devices
- Audit scope, criteria and objectives
- The role and responsibilities of an ISO 13485 Internal Auditor
- How to plan and prepare for an audit
- How to develop a checklist
- How to conduct a process audit
- How to report on audit findings
- Developing interviewing skills and techniques
ISO 13485:2016 specifically requires personnel to be competent – this course provides essential skills and knowledge to help delegates become fully competent auditors.
Organisations with certification to multiple ISO Standards may benefit from running an Integrated Management System; in this instance, an IMS Internal Auditor Course may be more suitable.
What you need to know
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What is the format of the course?
- Informative tutor-led lessons are combined with individual and team-based exercises (approx.. 25% theory and 75% practical).
- The use of a case study throughout the course supports the development of auditing skills.
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What is the course assessment?
- People will be assessed based on their overall participation in the course, including any interactive activities.
- There will be a short multiple-choice test on the final day of the ISO 13485 Internal Auditor course.
- Delegates are required to attend 100% of the course (CQI and IRCA rules).
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What type of certificate will I receive?
- After completing the course assessment, a CQI IRCA certificate is awarded for this ISO 13485 Internal Auditor course.
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What's included in the course fee?
- Pre-course work to help prepare for training (Training Toolkit)
- Delegate training manual
- Case Study documents
- Post-course notes
- CQI and IRCA certificate
- Lunch and refreshments (applicable when training at one of our venues)
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Do you have prior knowledge of ISO 13485? Save £50 when booking a Foundation + Internal Auditor course
FREE Training Toolkit
Our classroom and virtual courses come with a unique toolkit which helps you prepare for training, including:
Pre-course exercises
Series of training videos
Training manual
Book your course
- Easy to access online course
- Learn at your own pace, on a date and time to suit you
- Support from a dedicated e-learning team
| Delivery | Location | Date | Price (+ VAT) | |
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Workshop |
Bristol | 08 Jul 2025 - 09 Jul 2025 |
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Workshop |
Bristol | 17 Jul 2025 - 18 Jul 2025 |
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Workshop |
Milton Keynes | 30 Sep 2025 - 01 Oct 2025 |
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Online |
via Zoom | 18 Mar 2025 - 19 Mar 2025 |
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Online |
via Zoom | 10 Jun 2025 - 11 Jun 2025 |
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We can travel to any workplace worldwide and teach your team on a date to suit you. Alternatively, we also offer online team training which is ideal for larger organisations with employees at several locations. Simply send us your requirements to receive a quote.
- OFFER
ISO 13485 Foundation + Internal Auditor = £50 off
Find out when new dates are added, register your interest today.
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Learning styles for this course
Classroom Training
Traditional, face-to-face training delivered by an expert tutor in a physical classroom setting. Learn at one of our 6 UK training venues, or we can teach your team at your workplace.
Virtual Training
Access the course online via Zoom and interact with the tutor and other delegates in real time. Perfect for anyone who wants to learn from home or work without the need to travel.
In-House Training
Dedicated ISO training is available just for your team on a date and time to suit you. Suitable for a group of 4-12 auditors, we can travel to any workplace worldwide.
CQI and IRCA Certified Course
We are proud to be an Approved Training Provider for CQI and IRCA; the only organisation in the world that can award quality professionals with a Chartered status, making its brand one of the most trusted.Â
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When choosing a CQI IRCA-certified course, delegates can feel confident that the training will meet the requirements of an internationally recognised set framework.
Some of our happy customers
The course was packed with info and a great balance between learning and doing. The trainer really knows his subject well.
Stephen Reeder SMi Drug Discovery ISO 13485 Internal AuditorThe course was interesting and engaging as a group and the trainer was really informed. The training manual and course handouts were good and gave us more scope to work on our own trail of thoughts without giving too much away.
Gladwell Kozak Great Western Hospital, NHS Foundation Trust ISO 13485 Internal AuditorThe trainer made what was a very dry subject engaging, inclusive, and entertaining.
David Crellin Shandon Diagnostics Ltd. ISO 13485 Internal AuditorAn excellent tutor. He made the very dry course into interesting and easy to understand training. He left a very positive and lasting impression. Thanks.
Satya Chada Perspectum Diagnostics ISO 13485 Internal AuditorIt was informative, energetic and fun. The best training I have ever received. Was interesting and I retained a lot of information.
Sarah Richardson SPD Swiss Precision Diagnostics ISO 13485 Internal AuditorInformative, always relevant to the training topic, made training course interesting and interactive.
Reenal D’Souza Sarissa Biomedical ISO 13485 Internal AuditorReally engaging and made a dry subject enjoyable. I thought the trainer was particularly good at keeping the attendees engaged and making a rather boring subject really enjoyable and engaging.
Richard Tuck Gateshead Health NHS Foundation Trust ISO 13485 Internal AuditorThis type of training session keeps the delegates interested, attentive while still learning the core of the Standard content.
Ricardo Dagge SPD Swiss Precision Diagnostics ISO 13485 Internal AuditorThe tutor was very knowledgeable, very engaging and had an excellent inclusive style which managed to get the whole group to contribute and feel they were important and that their views were very welcome.
Richard SPD Development Company Ltd ISO 13485 Internal AuditorThe tutor was very entertaining, knows his stuff
Peter Gordon Shandon Diagnostics Ltd. ISO 13485 Internal AuditorInformative training course. Trainer was able to engage with the group and break down the various components of the training.
Nisha da Costa Eyeol UK Ltd. ISO 13485 Internal AuditorThe trainer was fantastic and his personality ensured the whole room was engaged throughout.
Michael Crowe Gateshead Health NHS Foundation Trust ISO 13485 Internal AuditorRelated Courses
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Let's level up your career together
Are you a new auditor looking for ISO training advice? Or do you want to build on existing auditing skills to boost your career?
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Whatever your need, our experienced and knowledgeable Batalas team can guide you on the right training path to help you reach your professional goals.
ISO 13485 Internal Auditor Training for your team
Do you have a group of employees who require ISO 13485 Internal Auditor Training? One of our expert tutors can visit your workplace and teach your team on a date to suit you, or we can even deliver the course virtually if you prefer.
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Let’s level up your career together
Are you a new auditor looking for ISO training advice? Or do you want to build on existing auditing skills to boost your career?
Whatever your need, our experienced and knowledgeable Batalas team can guide you on the right training path to help you reach your professional goals.