Online & Blended ISO 13485:2016 Internal Auditor Training (CQI & IRCA Certified)

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This CQI & IRCA Certified Blended ISO 13485:2016 Internal Auditor Training Course (online & classroom/virtual training) 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? The major benefit to blended training is that it offers each Learner the flexibility to learn more at their own pace and reduce the overall time spent in any type of classroom!

Course Snapshot

  • Course Duration:

    16 Hours
  • Format

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

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

    • Available in both blended formats (traditional or virtual classroom)
    • 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

    595 + €55 CQI & IRCA Certification Fee
  • Fee Includes

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Blended Training = 6hrs Online & Self-Paced + just 1-day Virtual Classroom

Blended Training = 6hrs Online & Self-Paced + just 1-day Virtual Classroom

This course is CQI & IRCA Certified (Course No. 2286)

Course DatesLocationCostHoursPublic CourseOnsite/Virtual Classroom
25th February 2021

Virtual Classroom Training

€ 595
( + €55 CQI & IRCA Certification Fee )
Includes: Online ISO 13485:2016 Foundation Course
6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)

Limited Places Available

26th May 2021

Virtual Classroom Training

€ 595
( + €55 CQI & IRCA Certification Fee )
Includes: Online ISO 13485:2016 Foundation Course
6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)
18th August 2021

Virtual Classroom Training

€ 595
( + €55 CQI & IRCA Certification Fee )
Includes: Online ISO 13485:2016 Foundation Course
6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)
11th November 2021

Virtual Classroom Training

€ 595
( + €55 CQI & IRCA Certification Fee )
Includes: Online ISO 13485:2016 Foundation Course
6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)
Include access logo

Recommended Course: Online & Self-Paced ISO 13485:2016 Foundation

Every Learner wishing to complete Internal Auditor training is recommended to first complete our Online & Self-Paced ISO 13485:2016 Foundation Course (8hrs) that focuses on providing a comprehensive understanding of Quality Management based on the ISO 13485:2016 requirements and the key prior learning topics for this course! Whether you are new to ISO 13485 or Auditing or an experienced Professional who would benefit from a Refresher, this course is strongly recommended & available at a 50% discount if purchased with this course.

  • Module 0 - Course Introduction (Online & Self-Paced)

    In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.

  • Module 1 - Introduction to Quality Management Systems (QMS) (Online & Self-Paced)

    In this module we will explore the purpose, benefits and structure of ISO 13485:2016, the 7 principles of quality management and the key audit related terminology of the standard. We will also explore the key concepts that underpin ISO 13485:2016, namely: Plan-Do-Check-Act (PDCA) cycle, process approach and risk management.

  • Module 2 - Introduction to Auditing (Online & Self-Paced)

    In this module we will explore the internal audit requirements as specified by ISO 13485:2016, the key terminology associated with the auditing standard ISO 19011:2018, internal audit program management, the audit lifecycle roles & responsibilities of the auditor and desired auditor behaviours.

  • Module 3 - Audit Initiation and Preparation (Online & Self-Paced)

    In this module we will explore the audit objectives, scope and criteria and the criteria for selection of the audit team. We will also expand on the audit lifecycle by exploring the first two phases namely “Initiate the Audit and Prepare Audit Activities” including preparation of the audit plan and development of the audit checklists.

  • Module 4 - Conducting Audit Activities (Online & Self-Paced)

    In this module we will expand on the audit lifecycle by exploring the third phase of the audit lifecycle, namely conducting audit activities. Topics to be covered will include, opening meeting, communication, audit methods, generating audit findings and the process for grading non-conformities.

  • Module 5 - Audit Report, Close and Follow up the Audit (Online & Self-Paced)

    In this module we will explore the final stages of the audit, namely: documenting the identified non-nonconformities and conducting the closing meeting. We will also explore, the last three phases of the audit lifecycle namely: preparing and distributing the audit report, completing the audit and performing follow up audit activities.

  • Module 6 - Course Introduction (Classroom/Virtual Training)

    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 (Classroom/Virtual Training)

    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 (Classroom/Virtual Training)

    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 (Classroom/Virtual Training)

    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.

CQI-IRCA-Certified-Course-logoThis course is fully certified by CQI & IRCA (Course No. 2286)


  • The Course was quite intense and required a lot of focus but i feel i took a lot of knowledge and new perspectives away from the course and feel quite confident in about putting that knowledge to use in real world situations

    Declan Reynolds | December 17, 2020

  • Great experience from start to finish. The instructor had vast knowledge of the subject matter answered all our questions and passed on some great tipsknowledge.

    Darren Hackett | December 17, 2020

  • I found the training very enjoyable and very professional. I was very impressed with how organised and knowledgeable our instructor Breda was and she made a great effort to build a good rapport with all the participants. Best online training course Ive done so far.

    Danielle Hamilton | December 17, 2020

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    Annette Kinsella | December 17, 2020

  • I thought the instructor was very knowledgeable and friendly. The material was presented in an engaging way. I would recommend teams of 3 minimum for breakout sessions going forward rather than just 2 if possible. The course was ran well online and virtually. I would recommend to colleagues.

    Niamh O'Halloran | December 3, 2020

  • Course was well presented and structured. no improvements required. Breda was very good at keeping the team involved and gave a very strong overview of the course.

    Matthew Monahan | December 1, 2020

  • Megan Moloney | November 30, 2020

  • Comply Guru provides an excellent virtual blended ISO 13485 and Internal Audit training course. Breda the course trainer is really knowledgeable with high skills and confidence.

    Nazanin Vahid | November 26, 2020

  • This was my first experience with blended learning. I am new to Auditing and I had limited experience it that area. I had basic knowledge of ISO 13485 before I started the course. I completed the Internal Auditor Training Course and thanks to Comply Guru I now have a Certificate in Internal Auditing.

    Susan Mullen | November 26, 2020

  • Raquel Boularot | November 26, 2020

  • I enjoyed the blended learning course. The online modules gave a great introduction to the course and help setup the mind frame for an internal auditor. When moving to the classroom a good recap was completed and exercises in each of the areas were completed. A enjoyable interactive learning experience.

    Marguerite Ryan | November 26, 2020

  • 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

  • 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 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

  • 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

  • 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

  • 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

  • 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

  • Absolutely brilliant effective training.

    Sarah Jane O'Farrell | 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

  • I was very impressed by the well-organised and structured course. It is divided into a self-managed and a classroom training session that provides you with a good 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 and obtain 70% or higher in the final assessment (part 1 of 2)
  • Fully attend the classroom element and obtain 70% or higher in the continuous assessment (part 2 of 2)
  • instructimg
    Breda Kearney

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

    Read More

  • instructimg
    John Collins

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

    Read More

  • instructimg
    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.

    Read More

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 (Recommended)

  • 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 (Required)

  • 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 (Required)

  • 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 (Required)

  • 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 continuous assessment.

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

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.

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

  • 97%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 96%

    Would Recommend Online or Blended Training over Classroom Training

Course Funding Available with Irish Medtech Skillnet

If you are interested in registering for a public training event or organising in-house training either as an Individual or a Company based in Ireland, you can contact Michelle Reinecke-Quain at Irish Medtech Skillnet on 061-431802 or email to learn about what funding supports are available to help those training budgets go further!

Custom Course Development

We can combine leading industry subject matter experts with an experienced eLearning team to help your organization with its compliance training needs.

Want to learn more? Get in touch.

Would you like to know more about our service? We have a dedicated sales team who would be happy to answer any questions that you may have.

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