What is a ISO 13485 Internal Auditor?

A highly interactive 2 day ISO 13485 internal auditor training course that enables delegates to interpret the requirements of the ISO 13485 medical devices standard from an auditing perspective, conduct effective audits and produce audit findings.

Who should attend?

  • People new to auditing and have been asked to conduct internal audits
  • Anyone involved in planning, managing and implementation of internal audit systems
  • Those needing to identify gaps in the effectiveness of your MS
  • Those wanting to achieve continual business process improvement

ISO 13485 specifically requires that staff are trained and that auditors are competent, this course satisfies this requirement.

What will you learn?

A detailed understanding of:

  • Medical devices, quality and auditing terminology
  • Auditing skills
  • Structure & intent of the medical devices standard ISO 13485 :2016
  • Planning, preparation and management of audits
  • Types of audit
  • Checklist development
  • Internal audit objectives
  • Conducting process audits
  • Internal audit scope and criteria
  • Reporting audit findings
  • The audit process
  • Verifying corrective action
  • Roles and responsibilities of the internal auditor
  • Interviewing skills

CQI-IRCA-Certified-Course

£945 + vat

2 Day Classroom Training Course

From 08:45 to 17:30

Includes full delegate manual, lunch, refreshments & certificate

In-house courses from £330 per person

FREE Training Toolkit – supporting you through your learning journey

Our classroom courses come with a unique toolkit which helps you prepare for training, including:

- Pre-course exercises
- Series of training videos
- Training manual

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Book Now Pay Later

97% Pass Rate

Average 99% Pass Rate

Money Back Guarantee

No Pass No Fee Guarantee

98%

98% of our delegates would recommend us

Our public courses run at training venues across the UK.

We offer a ‘BOOK-NOW-PAY-LATER’ policy which allows you to secure a place on the course whilst seeking approval from within your company (t&c’s apply).

Can’t see a date that works for you? Call our training team on 0333 700 9001 to get notified as soon as new dates are added.

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All prices exclude VAT

Don’t take our word for it

Informative, always relevant to the training topic, made training course interesting and interactive.
Reenal D'Souza, Sarissa Biomedical, ISO 13485 Internal Auditor, October 2019
I just wanted to say thank you for the internal audit training provided here at SPD. The trainees are extremely happy with the training experience and are singing from the roof tops with regards to the tutors training style.
Emma Nye, Head of Quality, SPD Swiss Precision Diagnostics, ISO 13485 Internal Auditor, December 2019
This 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 Auditor, December 2019
It 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 Auditor, December 2019
The trainer was great. Very clear on his direction and he made a boring topic entertaining. Overall it was great training.
Jorge Espinosa, SPD Swiss Precision Diagnostics, ISO 13485 Internal Auditor, December 2019
The trainer was fantastic and his personality ensured the whole room was engaged throughout.
Michael Crowe, Gateshead Health NHS Foundation Trust, ISO 13485 Internal Auditor, October 2019
Really 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 Auditor, October 2019
Informative 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 Auditor, April 2019
The course was highly suited to our needs and the trainer made what would have been otherwise dry material rather interesting.
Christopher Norfolk, Production Manager, UK Implant Ltd., ISO 13485 Internal Auditor, April 2019
Robert is an 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 Auditor, March 2019
I thought the pre course materials were good for prep providing a brief overview without being too time consuming. The structure of the course and the way the information was provided was great, i think we all benefitted a lot from the training. There was a lot of participation encouraged which kept everyone engaged, constant referrals to the ISO which made me feel more familiar with the document and how to use it, and the audit role play was excellent and exactly what we needed to get a bit of experience. The tutor played his role of an auditee really well to give us some experience of handling different situations we might encounter, the discussions and feedback after the audits was very helpful to share ideas as well.
Claire Collins, Yourgene Health, ISO 13485 Internal Auditor, February 2019
Despite not generally enjoying role play activities, the simulated audit was a good way to learn. I enjoyed the trainers commitment to the various characters he was playing, plus the quick reactive thinking to our comments as auditors.
Kelly Bull, Yourgene Health, ISO 13485 Internal Auditor, February 2019
The team really enjoyed the training with Robert and feel much more confident to go out and conduct the audits.
Cristian Dalea, Sensyne Health Co. Ltd, ISO 13485 Internal Auditor, October 2018
I want to say thank you for the excellent training process throughout, as always received from Batalas, hence my reason for returning to you so many times. The training was booked very efficiently and the training itself was well presented. The tutor was engaging, interesting and good presenter. I will be returning once again to you in the future when we have any further compliance and quality related training needs.
Fay Curd, ThermoFisher Scientific, ISO 13485 Internal Auditor, September 2018
I thought the best parts of the internal audit course were the activities, Q&A sessions, the pre coursework and of course the tutor to make the course fun, interactive and a great learning environment.
Sasha Low, Eumar Technology Limited, ISO 13485 Internal Auditor, September 2018
I thought Robert was exceptional, his engagement to a mixed ability group was very good.
Peter Kimber, Purchasing Manager, Datalink Electronics Ltd, ISO 13485 Internal Auditor, September 2018
Steve was great, very friendly, had great knowledge of the iso standards and presented the training very well. thank you all for the great service throughout
Dan Retallick, Polymermedics, ISO 13485 Internal Auditor, April 2017
The Batalas Trainer was extremely knowledgeable and professional. The course was well structured and delivery method was appropriate and facilitated learning and reflection. I would recommend this course to my colleagues.
Steve Fitzjohn, Defence Diving School Portsmouth, QMS Lead Auditor, May 2015
Dennis was extremely knowledgeable and was happy to apply the theory to real life situations which is always a great help. The course itself is ‘very’ intense with many hours out of class spent working on the material. Dennis was great he kept me fully engaged throughout.
Louise Ellison BA (Hons), GKN Aerospace Services, QMS Lead Auditor, May 2015
The personal experiences and first hand examples given by the tutor brought the course to life.
Lorraine Bell, Sage, QMS Lead Auditor, March 2015

Read more client testimonials here >

Some recent clients

Have you seen our fantastic Course Bundles?

Enjoy a discounted price when you book any of the below course bundles. This offer applies to public courses on ANY date** at ANY venue listed on the website.

Our course bundles also include the following benefits:

• ‘Book now pay later’ guarantee*
• ‘No pass no fee’ guarantee*

Batalas Special Offer

Batalas Special Offer

Please email training@batalas.com or call 0333 700 9001 to book your Course Bundle!

**Course dates must be consecutive. **t&c’s apply

ISO Standard Courses Bundle Price
ISO 9001:2015 1 day Foundation and 2 day Internal Auditor plus FREE Training Toolkit £1165 + VAT
ISO 9001:2015 1 day Foundation and 5 day Lead Auditor plus FREE Training Toolkit £1665 + VAT
ISO 14001:2016 1 day Foundation and 3 day Auditor Conversion plus FREE Training Toolkit £1465 + VAT
ISO 27001:2013 1 day Foundation and 5 day Lead Auditor plus FREE Training Toolkit £1665+ VAT
ISO 27001:2013 1 day Foundation and 3 day Auditor Conversion plus FREE Training Toolkit £1465 + VAT
ISO 13485:2016 1 day Foundation and 2 day Internal Auditor plus FREE Training Toolkit £1315 + VAT
ISO 13485:2016 1 day Foundation and 5 day Lead Auditor plus FREE Training Toolkit £2015 + VAT
AS9100:2016 Rev D 1 day Foundation and 2 day Internal Auditor plus FREE Training Toolkit £1315 + VAT
AS9100:2016 Rev D 1 day Foundation and 5 day Lead Auditor plus FREE Training Toolkit £2015 + VAT
ISO 45001:2018 1 day Foundation and 3 day Auditor Conversion plus FREE Training Toolkit £1465 + VAT
Tutor led sessions interspersed with individual and team based exercises (approx 25% theory and 75% practical). Extensive use of a case study to enable skills to be developed.
A CQI IRCA certificate will be sent to those who successfully complete the course assessment.
Includes full delegate manual
Lunch and refreshments
Certificate
Each delegate must attend 100% of the course. You will be assessed on your individual and group participation and general performance during the course, including the interactive exercises, case studies, role-play and any other activities covered on the course.

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