Blended ISO 13485:2016 Internal Auditor Training | CQI, IRCA & Exemplar Global Certified

(18 Reviews, Click to view)


This CQI, IRCA and Exemplar Global Certified Blended ISO 13485:2016 Internal Auditor Training Course (online, self-paced & virtual classroom) is ideal for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 13485:2016 and wants to gain an in-depth understanding of the process for performing internal audits of part of their QMS

Did you know? This course is delivered both online (self-paced) & in a virtual classroom with a Live Instructor. Each learner must complete a 6hrs online, self-paced training before attending a virtual classroom-based 1-day skills-based training session. The major benefit to this approach is that it offers each Learner the flexibility to learn at their own pace and reduce the overall time spent in ANY type of classroom!

Request a free demo today to see if our training is for you!

Course Snapshot

  • Course Duration:

    16 Hours
  • Format

    Blended Course (6hrs Online & Self-Paced + 1-day Virtual Classroom)
  • Accreditation

    CQI and IRCA approved training partner
    CQI & IRCA Certified Course (No. 2286)
    PLUS Exemplar Global Certified Course
  • Delivery Options & Discounts

    • Available on select public dates & for in-house training for groups of 4+.
    • Multi-Person Discount: Book 3, get a 4th Place Free (Same Course & Dates Apply)
  • Price

  • Fee Includes

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Finally, an industry-leading online & blended training solution for compliance and certification!

Comply Guru™ offers a library of online & blended compliance training courses to enable its Learners to get the knowledge and skills they need, from the same systems and devices they use every day

Learning Anytime, Anywhere with Self-Paced & Virtual Learning
Learning Anytime, Anywhere with Self-Paced & Virtual Learning

Learning Anytime, Anywhere with Self-Paced & Virtual Learning

CQI & IRCA (No. 2286) & Exemplar Global Certified Course

Start DateLocationCostDurationVirtual Classroom


$ 1195.00
6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)
Includes Access Logo

Includes Online ISO 13485:2016 Foundation [Additional Course]

Available from June 1st, each Learner will receive access to an additional Online ISO 13485:2016 Foundation Course (7hrs) that focuses on the core ISO 13485:2016 requirements and other key prior learning topics! This online foundation is included to ensure each Learner is well prepared, meets the prior learning requirements & gets the most out of their training!

  • Part 1 = Modules 0 - 5 (Online & Self-Paced)

    In order to attend this training, each Learner must successfully complete the Online ISO 13485:2016 Internal Auditor Knowledge & Theory Course (6hrs) which consists of 5 modules (online).

  • Module 6 - Course Introduction (Virtual Classroom)

    In this module, an introduction to the classroom element of the blended course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & training delivery.

  • Module 7 - Planning the Audit (Virtual Classroom)

    In this module we will explore the key steps that are required to plan the audit using a risk-based approach. We will also practice the skills required to prepare the necessary documents for the audit including the audit checklist.

  • Module 8 - Conducting the Audit (Virtual Classroom)

    In this module we will practice the skills required to effectively conduct an audit using a sample of QMS documentation. A variety of audit methods will be used including interview, document review and data analysis.

  • Module 9 - Report, Close and Follow-Up the Audit (Virtual Classroom)

    In this module we will practice the skills required for conducting the closing meeting, preparing the audit report and verifying that actions taken to address audit findings were effective.

This course is fully certified by CQI & IRCA (Course No. 2286)

Exemplar Global

This course is also Exemplar Global Certified.

In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the online examination (pre-Virtual Classroom), plus attend 100% of the virtual classroom sessions. Successful completion will entitle each Learner to receive a dual-accreditation Certificate of Achievement.

Comply Guru are proud to announce that we have been granted approval by CQI & IRCA to offer virtual training – on our approved blended training courses.

What is Virtual Classroom Training?

This means that for the “classroom” portion of the training, we can offer virtual training as an option for those that prefer to complete their training via a virtual classroom with a Live Instructor.

Virtual training is an alternative format to complete your training – but it will remain highly interactive & collaborative – the same as it would in a traditional classroom environment.

The virtual classroom format will involve shorter “live” sessions with an Instructor on the training days – including regular breaks & interactive assignments (individual & team-based work) for an enjoyable & engaging learning experience.

Is the course still certified?

Yes, the course is still certified and all Learners who successfully complete the full program will receive a CQI & IRCA Certificate of Achievement.

What do you need to participate?

To participate in the virtual training sessions, you will need:

  • Laptop or desktop computer (Note: A tablet or mobile device is not suitable for this training)
  • Webcam – Built-in or USB plug-in
  • Speakers and a microphone – Built-in or USB plug-in. We strongly recommend a headset if you have this available
  • Internet connection – Minimum of 1.0Mbps

How will Comply Guru help you prepare in advance?

1 week in advance of every  training course, we will be hosting an on-boarding & familiarisation virtual training session with all Participants.

This advance session will recap on the key learning outcomes from the online modules completed & ensure every Participant is comfortable and familiar with the software and tools that we will use during the virtual training.

For any Participant that is experiencing any issues, these can be identified & support will be available both before and during any virtual training course.

  • I thought the training with Comply Guru was great We learnt a lot through the online modules and the intensive day course. The organization of the course was thorough and dynamic and our course instructor was personal knowledgeable and helpful. Would definitely look for Comply Guru for any future training courses we need.

    Ashley Sekulich | October 6, 2020

  • The interactive classes and practical learning were excellent.

    Estela Hardisty | October 1, 2020

  • Comply Guru are a very helpful positive and professional company. They are very quick to respond to any query and provide very good material layout and support throughout the course. Breda is an excellent instructor with a depth of knowledges she generously shares with all. Tough taskmaster good at role playing and all combined with sense of humour which contributes to the fun of learning. Very enjoyable form of learning and I would highly recommend.

    Gerry McNamara | September 29, 2020

  • I found this course great Breda was great and the training was amazing.

    Jade Dalton | September 29, 2020

  • Overall an excellent belended course that gave me the foundational basis and practical knowledge to build on my internal auditing experience.

    Heather Ryan | September 14, 2020

  • Absolutely brilliant effective training.

    Sarah Jane O'Farrell | September 10, 2020

  • The course was excellent. I have participated in a lot of training courses and this one was very well led with good support and knowledge from the tutor.

    Tim Cully | September 10, 2020

  • Overall this course was brilliant. with it being a blended course the first part focused on building your background knowledge at your own pace and the online classroom based course was really interactive and got you thinking.

    Liona Carroll Crowley | September 10, 2020

  • Excellent approach to training. I found that the blended learning approach suited me having both parts separate meant that the training was balanced well between theory and practical application. Great support from the instructor and all at comply guru in the lead up and during the course.

    Jacinta Kilmartin | September 10, 2020

  • Breda was a great trainer and was able to explain any questions we had very simply and in a way that we could easily understand.

    Emma O'Brien | September 10, 2020

  • The overall training was very professional and knowledgeable. The role play exercises were beneficial as they provided a real life experience

    Aisling Hassett | September 10, 2020

  • Thanks to Breda specially and the team her knowledge and interaction and support during the course its been fantastic

    Alicia Baldonedo | September 10, 2020

  • The Course was very well prepared and I really enjoyed it.

    Karolina Cygan | July 28, 2020

  • The content of course was comprehensive and well structured. The online modules were self-paced and being accessible at any time was handy. The classroom portion of the course delivered virtually via Zoom worked well the tutor had an in-depth knowledge of the auditing process and was able to give real life examples from her own auditing experience. Feedback on the assessments was constructive and useful the additional class giving an overview of the individual clauses of ISO13485 prior to the classroom day was beneficial.

    Stephen Byrne | July 24, 2020

  • understanding of the ISO 134852016 and good knowledge on how to prepare and conduct an Internal Audits. The one day course via Zoom was in a group based environment with a very competent tutor. The assessments provide a good feeling of how an internal audit as an Auditor would look like. All in all an extremely good experience and I am looking forward to do more courses with Comply Guru.

    Miriam Heinlein | July 23, 2020

  • Celine Heslin | July 22, 2020

  • Mark Tarmey | July 22, 2020

  • Good mix of classroom based and online learning exercises. Tutor was very helpful and knowledgeable

    Mandy Holmes | July 22, 2020

In order to successfully complete this blended course, each Learner will need to:
  • Complete the online course (self-paced) and obtain 70% or higher in the final assessment (part 1 of 2)
  • Fully attend the virtual classroom element and obtain 70% or higher in the continuous assessment (part 2 of 2)
  • Instructor Image
    Breda Kearney

    Breda leads the design of Comply Guru’s internationally accredited CQI & IRCA Certified Online & Blended Training Programs.

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  • Instructor Image
    John Collins

    John has over 20 years’ experience as a Quality Professional & is a specialist in Quality Management Systems.

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  • Instructor Image
    Shane Curran

    Shane is a specialist in Management Systems & has been working with international ISO standards and a myriad of management systems for well over 15 years.

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What each Learner should know before completing this course:

CQI & IRCA recommend that each Learner have the following prior knowledge before completing this course:

Management Systems

  • The Plan, Do, Check, Act (PDCA) Cycle
  • The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.

ISO 13485

  • Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
  • Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course may be very challenging.

Fluency in spoken and written English

  • For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.

Printed Copy of ISO 13485:2016

  • Each participant should bring a printed clean copy of the standard with them to the course. This is not provided by Comply Guru.
Important Note: The Learners understanding of the prior knowledge requirements will be tested as part of the course assessments.

E-Learning System Requirements

The below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS)  may be impacted, restricted and may not perform well.

Recommended Operating Systems

Windows 7/10, Mac OSX Sierra, iPad IOS10

Mobile Devices

Comply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.

Internet Speed

We recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content

Recommended Internet Browsers

  • Google Chrome 32 bit version 50 or later
  • Safari 10 or later
Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge are not recommended as its not compatible with the LMS and the course functionality will not work properly.

Recommended Settings

We recommend that the following settings are enabled:
  • Cookies
  • Pop-ups (in both Internet Browser and security software)
  • JavaScript
  • Plugins
  • Latest Version of Adobe Flash Player
  • Latest Version of Adobe Acrobat Reader
To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.

Technology Requirements for Virtual Training

To participate in the virtual training sessions, you will need:
  • Laptop or desktop computer (Note: A tablet or mobile device is not suitable for this training)
  • Webcam – Built-in or USB plug-in
  • Speakers and a microphone – Built-in or USB plug-in. We strongly recommend a headset if you have this available
  • Internet connection – Minimum of 1.0Mbps

Some Companies that have used Comply Guru™

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The Numbers - How We Are Doing

  • 100%

    Our Pass Rate

  • 100%

    Would Recommend Comply Guru

  • 99%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 95%

    Would Recommend Online or Blended Training over Classroom Training

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