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

(81 Reviews, Click to view)


This CQI & IRCA Certified Blended ISO 13485:2016 Lead 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 the knowledge and skills required to perform first, second and third-party audits of QMS against ISO 13485:2016, in accordance with ISO 19011:2018 and ISO/IEC 17021-1:2015

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:

    40 Hours
  • Format

    Blended Course (16hrs Online & Self-Paced + 3-days Traditional or Virtual Classroom)
  • Accreditation

    CQI and IRCA approved training partner
    CQI & IRCA Certified Course (No. 2244)
  • 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

    1195 + €60 CQI & IRCA Certification Fee
  • Fee Includes

A video about Comply Guru's online training library for compliance and certification

Learn More About Comply Guru's Big Vision

This video is some of the highlights from a Q&A Session with Eoin P. Kelly, Founder & CEO of Comply Guru, regarding the big vision for Comply Guru; various topics & whats in the pipeline for 2020!

Blended Training = 16hrs Online & Self-Paced + just 3-days Virtual Classroom

Blended Training = 16hrs Online & Self-Paced + just 3-days Virtual Classroom

This course is CQI & IRCA Certified (Course No. 2244)!

Course DatesLocationCostHoursPublic CourseOnsite/Virtual Classroom
16th February 2021
17th February 2021
18th February 2021

Virtual Classroom Training

€ 1,195
( + €60 CQI & IRCA Certification Fee )
Includes: Online ISO 13485:2016 Foundation Course
16 Hours (Online & Self-Paced) + 3 Days (Virtual Classroom)

Limited Places Available

11th May 2021
12th May 2021
13th May 2021

Virtual Classroom Training

€ 1,195
( + €60 CQI & IRCA Certification Fee )
Includes: Online ISO 13485:2016 Foundation Course
16 Hours (Online & Self-Paced) + 3 Days (Virtual Classroom)
20th July 2021
21st July 2021
22nd July 2021

Virtual Classroom Training

€ 1,195
( + €60 CQI & IRCA Certification Fee )
Includes: Online ISO 13485:2016 Foundation Course
16 Hours (Online & Self-Paced) + 3 Days (Virtual Classroom)
12th October 2021
13th October 2021
14th October 2021

Virtual Classroom Training

€ 1,195
( + €60 CQI & IRCA Certification Fee )
Includes: Online ISO 13485:2016 Foundation Course
16 Hours (Online & Self-Paced) + 3 Days (Virtual Classroom)
7th December 2021
8th December 2021
9th December 2021

Virtual Classroom Training

€ 1,195
( + €60 CQI & IRCA Certification Fee )
Includes: Online ISO 13485:2016 Foundation Course
16 Hours (Online & Self-Paced) + 3 Days (Virtual Classroom)
Include access logo

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

Every Learner wishing to complete Lead 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 and benefits of a QMS and an overview of the ISO 13485:2016 standard will be provided.

  • Module 2 - Key Concepts of ISO 13485:2016 (Online & Self-Paced)

    In this module an introduction to the key concepts that underpin ISO 13485 including the PDCA cycle, process-based approach, risk based thinking and management commitment and the significance of these for the QMS Auditor.

  • Module 3 - Introduction to QMS Auditing (Online & Self-Paced)

    In this module an introduction to QMS auditing including coverage of the certification audit process will be provided.

  • Module 4 - Planning the Audit (Online & Self-Paced)

    In this module we will explore the initial audit planning steps including determination of the audit objectives, scope and criteria and selection of the audit team.

  • Module 5 - Audit Initiation and Preparation (Online & Self-Paced)

    In this module we will explore the activities associated with the first two phases of the audit lifecycle including establishing contact with the auditee and development of the audit plan and audit work documents.

  • Module 6 - Conducting the Audit (Online & Self-Paced)

    In this module we will explore the opening meeting, the need for effective communication and the methods available to the QMS auditor for collecting information and audit evidence.

  • Module 7 - Generating Audit Findings and Closing Meeting (Online & Self-Paced)

    In this module we will explore the process for generating the audit findings, agenda for the final audit team meeting and the closing meeting.

  • Module 8 - Audit Reporting, Completion and Follow-Up (Online & Self-Paced)

    In this module we will explore the final three phases of the audit lifecycle including coverage of the audit report, steps required to complete the audit and requirements for following-up on the audit.

  • Module 9 - Course Introduction [Classroom/Virtual Training]

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

  • Module 10 - 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 conduct a document review in preparation for the audit and practice the skills required to prepare the necessary documents for the audit including the audit checklist.

  • Module 11 - Conducting the Audit [Classroom/Virtual Training]

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

  • Module 12 - Generating Audit Findings and Closing Meeting [Classroom/Virtual Training]

    In this module we will practice the skills required to write and grade non-conformities and determine audit conclusions. We will also practice the skills required to conduct a closing meeting

  • Module 13 - Audit Report and Follow Up Activities [Classroom/Virtual Training]

    In this module we will practice the skills required to prepare the audit report and to evaluate audit responses including differentiating between a correction and corrective action.

This course is certified by CQI-IRCA (Course No. 2244).



  • This was an excellent course. The blended venue meant that I was able to attend. The course exercises were germane. The test was good gauge of achievement. This course was worth the investment.

    Ian Millett | December 14, 2020

  • Was a great experience Comply Guru are always great Very well ran courses

    Jade Dalton | December 8, 2020

  • Excellent course Great staff and the Zoom class was interesitng anf engaging.

    Kieran Connole | December 8, 2020

  • Great training on becoming a lead auditor with ISO 134852016. Breda our instructor was absolutely brilliant.

    Laura Creaven | December 8, 2020

  • Really enjoyed the course Learned a lot John and Breda were experts . Have recommended to others within my team.

    Leeroy Casserly | December 8, 2020

  • really great course the blended learning allowed for self paced learning and then hands on engagement with peers in industry really great discussions and the fact we had the learner manual sent to us was amazing

    Aoife Walsh | December 8, 2020

  • I really enjoyed the course. The auditors were very knowledgeable and friendly which I really liked. The pace was great and the chat between all the attendees was really emjoyable.

    Lisa Comer | December 8, 2020

  • I did find the course intense but this was possibly trying to fit this with working from home completing projects managing a team and the time of year. I learnt so much from the course and the facilitator was responsible for this. I would definitely attend a course through Comply Guru again and would recommend

    Shona Murphy | December 8, 2020

  • I would recommend Comply Guru ISO 13485 Lead Auditor training course for anyone wanting to develop their auditing skills. The course is very well structured and it provides learners with the concepts and skills necessary for auditing. Special credit to the instructors. Breda and John were extremely knowledgeable and willing to share their thoughts experiences and opinions. The language was very clear and understandable.

    Katarzyna Kiedrowska | December 8, 2020

  • Breda was very friendly accommodating to all questions and very knowledgeable of the standard auditing. Her teachings were added to by stories and real life examples.

    Ciara St. Ledger | December 8, 2020

  • I enjoyed this training as it was informative and fun. Was well put together by providing the background knowledge and the practical experience.

    Olivia Rice | December 8, 2020

  • The training was excellent and I have a great understanding of ISO 13485 as a result

    Brian Purtill | December 8, 2020

  • course was very compact would have been more ideal to get a bit more time. issue from our side of things since I hadnt seen the standard before I should have completed the foundation course 1st before implementing the lead auditor course. have highlighted this to the manager as a recommendation. A mock exam would be helpful to do it when you get to a standard that your ready for the exam but what to see how you do on what you know before going into study mode and see where you went wrong.

    Aoife Carbin | December 8, 2020

  • Comply guru provided a very positive enlightening training experience. Everything from the pretraining introduction sessions to the email prep information and meeting set ups were well structured and provided the information clearly. The instruction and support for mechanics of an online exam were very well prepared communicated.For any of my future training needs comply guru will be the first search.

    Kevin Conlon | December 8, 2020

  • It was intense informative fast paced and enjoyable. They were long days that flew by and that is testament to course content and the tutors ability.

    Ger Fitzgerald | December 8, 2020

  • The course is very well put together. I enjoyed both the self-paced learning and virtual training elements. It has helped to build my knowledge and confidence. Thank you Would highly recommend

    Shannon Wilson | December 8, 2020

  • Thank you for the great course I really enjoyed it .The instructors were experts both Breda and John style were well suited to the class and very interactive - there was plenty of opportunities to ask questions and in many cases real life example questions were answered with real life example answers Making it really relevant to anyone working in the Industry. This is a very well organized online course.

    | December 7, 2020

  • Great course very interactive - Instructors Breda John were very animated and painted a very honest view of auditing with great tips for not only carrying out an Auditor Role but also for an Auditee. Great backroom support provided both mentors were very approachable and created an excellent practical environment. Would definitely recommend.

    Charlotte Dugdale | December 5, 2020

  • Very experienced trainers well versed in their subject material and with an infectious attitute to the subject at hand. They definitely got the most of all the trainees including me. Result.

    Brian Bryce | December 3, 2020

  • The course extremley well structured and presented. All comments were taken in to consideration and tweaks to the training were made to facilitate the needs of the class. The instructor was so knowledgeable professional and approachable at all stages through the training despite the new normal we find ourselves in. Overall it was definitely the best training I have received in a very long time.

    Sarah Killian | December 3, 2020

  • I would highly recommend the Comply Guru ISO 13485 Lead Auditor training course. The blended learning format worked really well as the first two days were self-paced. Although the final three days were intense the break in between meant there was a greater opportunity to absorb the information. Both tutors brought their considerable knowledge and experience to the course which helped facilitate our learning.

    Angela Higgins | December 3, 2020

  • Very good course with very knowledgeable tutors - very apparent that they know the ISO134852016 standard and were able to answer any question posed.

    Sharon Coyle | December 3, 2020

  • Very clear training delivered by excellent and knowledgeable instructors who also showed a great deal of care to their students as well.

    Hilary King | December 3, 2020

  • I attended the blended course from the USA and even with the time difference I absolutely would recommend this course to anyone who is interested. Well structured and planned with no hidden surprises. The course content was well designed with a lot of team exercises and role play activity with case studies which made learning easy and kept me engaged throughout the course duration. The instructor was just phenomenal.

    Ashweni Narendra | October 9, 2020

  • It was a great course. I didnt think it would be very interesting to be honest But the online modules had good variety and the online training with Breda was very well delivered. I definitely learned a lot Breda was able to give many real world examples or scenarios to explain different things and we learned a lot about the whole audit process.

    Robert Casey | October 9, 2020

  • This course was excellently delivered and the content was all relevant.

    Kevin Claffey | October 9, 2020

  • The course was very well put together and Breda was so friendly welcoming helpful and full of knowledge. The zoom aspect was brilliant and easy to use. The addition of the small kahoot quizzes really helped to bring a bit of a laugh into the course.

    Nicole Bartley | October 9, 2020

  • Andreas Diplas | July 22, 2020

  • A great first experience for me with ComplyGuru I would recommend this course to the internal auditing team for the the purpose of improving our knowledge and experience so that we can obtain better results from our internal auditing program.

    Jennifer Brett | July 8, 2020

  • Very enjoyable course. The style and pace of the course was excellent. Although the remote working can be tiring using the screen constantly the whole process felt well planned and in control. Both Breda and John are outstanding trainers and an absolute credit to Comply Guru. They have an ability to involve everyone one of the better courses completed for participation. Definitely would recommend this course to others.

    Pauline McManus | July 7, 2020

  • Really enjoyed the course the instructors were very knowledgeable and accommodating.

    Claire Aspell | July 7, 2020

  • Found the course very informative. Really gained a good understanding of ISO13485 requirements.

    Michael Galvin | July 7, 2020

  • Tutors are experienced and shared lot of information it was very useful to understand and implement the auditing techniques and preparation of the check list conducting opening and closing meeting etc..

    Mohankumar Krishnappa | July 7, 2020

  • An excellent well managed course.

    Deirdre Quigley | July 7, 2020

  • Everything went well. Maybe more emphasis on the aspect of the patient safety should be dopne

    Stanislav Praslov | July 7, 2020

  • This course was very practical and applied. Having the theoretical aspect completed before the classroom part was great. Everyone could hit the ground running with all the basic knowledge in place. I never thought a virtual classroom could be so engaging. There were great discussions had by everyone. I learned way more than I thought I would and I think it will stick with me far beyond the course.

    Louise Barrett | July 7, 2020

  • What a fantastic training I am over the moon. This was my 3rd LA course in the last 30days a 3rd ATP as well and Comply Guru CG deserves a 1010 others are at 7 or 8. The tutors John Breda were simply awesome with a ton of knowledge. CG is ahead in the race in delivering training when compared to other way more experienced ATPs. Astounding team Eoin Kelly

    Sheshadri Nagaraja Nittoor | July 7, 2020

  • I would advise any auditor to attend this training. I took an awful lot from the course and I am delighted I completed it.

    Theresa O Reilly | July 7, 2020

  • Ive done both blended and virtual blended. Liked both but really feel I got more when I was with Breda in the classroom. she is just an excellent trainer. her transmission of the knowledge is without unnecessary affect or drama. Im extremely black and white though and can get easily boggled by too many grey areas.

    Angela Curran | July 7, 2020

  • Very professional knowledgeable attentive considerate and inclusive.

    Alison Murphy | June 11, 2020

  • Training was very demanding and informative and diversely.

    Hatice Ermis | June 10, 2020

  • Ive enjoyed very much the training

    Ricardo Rodriguez Garnica | June 10, 2020

  • I really enjoyed participating in this course, the combination of on-line self managed learning, virtual classroom, continuous assessment, team based learning, role play and quizzes was very interactive and kept the course moving along at pace. Virtual training certainly requires an adjustment but if you are concerned about sitting staring at a screen all day there is no need you will be pleasantly surprised at how different virtual learning can be. For me the course materials and structure were really good but the tutors who were very experienced and knowledgeable brought it all together. They were very willing to engage and share their experience and conveyed the intent of the standard/approach in a very meaningful and practical way. I can't thank the team enough for the learning opportunity and getting me over my virtual learning fears!!!

    Niamh O'Mara | June 10, 2020

  • My experience with Comply Guru was excellent. Any minor technical issue I had on my end was quickly fixed allowing the modules to run seamlessly.

    Tim O'Donoghue | June 8, 2020

  • It was great to have first an on-line training because we had the possibility to do that on our own rythm and to go back there anytime we wanted. Classroom session was really well organized and trainers are really competent

    Stephanie Maunat | June 8, 2020

  • good structurethe 3 days of virtual training were already very exhausting maybe you could split it into 5 days to take the pressure off

    Christina Fiebig | June 8, 2020

  • Due to language difficulties it was hard for me to follow the speech pace sometimes but it was always possible to ask questions and every important information was outlined more than once so I never felt to fall behind - that was very good

    Helge Grabbe | June 8, 2020

  • Thought course was well delivered by instructors.

    Andrew Hogan | June 7, 2020

  • Very well managed by having periodic quizz and self managed learning. The instructors were available to answer any questions. They have a huge knowledge.

    Justine Mestre | June 7, 2020

  • The quality of instruction was excellent. Instructors are experts and communicate effectively.

    Rob Naslund | June 6, 2020

  • The virtual course very engaging given by experienced auditors.

    Sarah Dolan | June 6, 2020

  • Breda and Shane are excellent instructors They will feed the material as well as personal input and advise to help drive this training.

    Reny Rosales | May 26, 2020

  • Really enjoyed the training and the discussions were great. Very knowledgeable instructors with good practical examples

    Clare O'Gorman | May 25, 2020

  • Very good training. You cant get bored due to to long speaking by the instructor. Lots of team tasks.

    Benedikt Hirt | May 25, 2020

  • This training was extremely well ran and every little thing was thought of from breakout sessions on zoom to role play exercises and auditing hints and tips along the way. Intense course but delivered by highly knowledgeable and skilled tutors who made the course as easy to understand as possible.

    Charlene Curran | May 25, 2020

  • The course was intense but very well structured with pre-course activities that enabled the online class activities to focus on the key aspects considerations execution of lead auditing activities. The online structure incorporated a good mixture of lectures videos assignments group activities with feedback and model examples. The tutors were exceptionally knowledgeable and gave great direction as to how to correctly approach leading an audit and how to approach the lead auditor exam for successful completion.

    Joe Kilbride | May 25, 2020

  • Aine Ni Obain | May 25, 2020

  • I absolutely loved doing my course with comply guru. The trainers are so supportive from start to finish. I would highly recommend complyguru. Looking into my next course already.

    Claire Keogh | May 23, 2020

  • Knowledgeable instructors. Engaging activities despite virtual environment.

    Alison Llave | May 23, 2020

  • First time completing a blended learning virtual course. It was really successful. It opened up a new way of learning for me and it is very flexible.

    Caterina Sheehan | May 23, 2020

  • In taking the ISO 134852016 Lead Auditor training class it was a great way to complete the training in only a few days by doing alot of the classroom training up front. This upfront training allowed for the classroom training to be more indepth and to do practical applications.

    Kathy Bahls | May 23, 2020

  • The course was prepare in high standard. Knowledge was presented in simply and understanding way. The material for the course was easily accessible.

    Jadwiga Naskret | May 22, 2020

  • I found the training to be very well structured. The virtual training was quite interactive and enjoyable. The instructors Breda and John are very knowledgeable and reachable. One of the best auditor trainings that I have attended so far.

    Kean Beng Ho | May 22, 2020

  • ComplyGuru have successfully adopted the format of ISO lead auditor certification to a vitrual course. they communicated and followed up regularly and allowed time beofre and afeter vitrual sessions to catch up with the group

    Mairead Glynn | May 21, 2020

  • Training was provided effectively and professionally it was clear a lot of thought went into the structure of the modules and the layout of the course itself.

    Renata Von Beaumont | May 21, 2020

  • I really enjoyed the lead auditor training course provided by Comply Guru. It was presented on line and was very well constructed. I found the support team of Breda John Eoin to be highly knowledgeable and very approachable throughout the entirety of the course. The course provided me with a lot on new skills but also provided me with new insight which I feel will really benefit me in my role as a quality engineer.

    Jonathan Canavan | May 21, 2020

  • An excellent course well put together by Breda and the Team. It delivered the content in a relaxed manner. It did not lose sight of the importance of understanding the content but also how this needed to be applied in the exam environment

    Patrick Ford | May 21, 2020

  • The training provided was perfect. The support from trainers was perfect. I have already recommend the course to my friends.

    Agnieszka Paprocka | May 21, 2020

  • I found this course really well presented. The course content was very good and it was very evident that a lot of work went into ensuring the course was effective. Both Breda and John were very knowledgeable and helpful throughout the course and even prior to starting. I thought the breakout sessions were good and broke up the course well. There was also a good sense of fun in the course.

    Michelle Donnellan | May 20, 2020

  • I partecipate to the Training for ISO 134852016 Lead Auditor. The course is very well prepared and organized. I really loved the activities to be performed in group and the audit simulation exercises. Overall really great experience.

    Alessandro Stella | May 20, 2020

  • Comply Guru have put together a comprehensive market leading training package with this certified Lead Auditor Course. Using the latest video conferencing and document sharing technology online training packages electronic quizzes auditor manuals slide decks and excellent tutors there was an inventive mix of learning techniques that proved really effective. The course was enjoyed by all participants.

    Brendan McLaughlin | May 18, 2020

  • The virtual training was a much more enjoyable experience than I had anticipated.

    Shane Curran | May 15, 2020

  • Faultless delivery of both online material and especially the virtual classroom training module. Compliance Guru is leading the way with this platform of training and is taking training to another level. Way ahead of the pack on this one Fantastic experience all around.

    Michelle Keane | May 15, 2020

  • Have a look at Q18 of this likely yesno responseComply Guru did a super job very professional very focused dedicated and hard working. I wish them well in the future.

    Marilla Keating | January 27, 2020

  • I had never undertaken a blended learning course before the structure was far better than I expected. The on-line portion was very detailed and the knowledge checks assessments and audit scenarios were very beneficial in getting you to apply the knowledge you had just gained. An advantage of the on-line portion is that it sets you up very well for the classroom training. It sometimes takes a while to kick off a training course as you get up to speed with the basics we had this going in and we could hit the ground running.

    Sharon White | December 20, 2019

  • A great experience staff were knowledgeable friendly professional and passionate about the subject matter. Also very approachable and it is very obvious that thy care about all aspects of the course and want to provide good value which they do Due to unavoidable circumstance the change in tutor for the last day somewhat disrupted the flow. The summary of the corse content could be improved. At this stage it is all about the exam Suggest a half hour quick review of a sample paper stating the length of answers required for all stages would also suggest that it may be beneficial to start with question 4 then 3 before competing the last parts. Time pressure is a factor and its unfortunate that when one is running short of time that this equates to when one is answering the highest amount of marks available would even go so far to say that section 4 move to the present section 1 present section 3 move to 2 present section 1 to 4 may sound pedantic but time is crucial especially when panic might set in

    Brian O'Connell | December 19, 2019

  • The course was excellent - the blended nature meant the trainee could complete online training and preparation at their own pace and familiarise themselves with the standard; this eliminated time wasting in class and meant everyone was familiar with the standard when they arrived in the classroom. The classroom exercises and discussions were designed to aid learning and application of the standard and time was optimised. The course design really suits a busy professional who cant afford to take 5 days out of busy schedules for classroom training; without losing any of the learning in the shorter time frame due to the blended design. The tutor was excellent and his knowledge and experience showed and indeed made the 2 days seem shorter and not one Powerpoint slide was utilised!

    Olivia McDermott | December 18, 2019

  • Overall my training experience was fantastic, the support I received from Comply guru was fantastic so reassuring and helpful. I found online part of the training brilliant very helpful for me to complete over a period of time and at my own time. the best part was the examinations and knowledge questions throughout it really helped me to see if I am on the right track. The class room training is where I learned a lot of valuable knowledge it help put the pieces together from the online course. The instructor John was fantastic so knowledgeable.

    Aaron Dolan | December 18, 2019

  • The on-line portion of this course was excellent. The content was well presented and nicely laid out with good indication of progress to me as a learner at all times. I enjoyed the mix of presentation styles and was attentive throughout. The competency assessment aspects were robust. The classroom aspect needs more planning and needs to follow the materials more closely so the learner has a sense of where they are. As I knew the topic well before the formal training, I was fine, but less experienced students may have struggled. Having a different tutor on day 3 was disruptive. Overall, it was a positive experience and with better planning and structure for the classroom aspect and tutor available for full course, I would recommend this course to colleagues. Best of luck in this new venture as I believe this method of training delivery to be very useful.

    Rita Woodings | December 18, 2019

  • The blended learning aspect allowed me time to prepare for the classroom based learning - I would not have been in a position to sign up for 5 straight days as their is not enough room in my calendar for that

    Deirdre Barrow | December 16, 2019

  • As I said in class - it was great, especailly when I was under pressure to get the course complete. Online is a big advantage

    Eilish Fitzpatrick | December 16, 2019

In order to successfully complete this blended course, each Learner will need to:

Before The Classroom Modules

  • Complete the online course modules and obtain 70% or higher in the final assessment (2 Online MCQ-based Assessments) by the required deadline set in advance of the given classroom dates you are registered for

During The Classroom Modules (Option A)

  • Fully attend the classroom element as 100% attendance is required
  • Obtain 70% or higher in the course continuous assessment during the classroom element

During The Virtual Classroom Modules (Option B)

  • Fully attend the virtual classroom element as 100% attendance is required
  • Obtain 70% or higher in the course continuous assessment during the virtual classroom modules

After either Classroom Modules (A or B) – eAssessment – NEW!

  • Completed Remotely or In-Person. Each Learner must obtain 70% or higher in a 2-hour CQI & IRCA eAssessment which is completed securely online (under strict examination conditions)
Successful completion will entitle each Learner to receive a CQI & IRCA Accredited Certificate of Achievement.
  • instructimg
    John Collins

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

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  • 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.

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  • instructimg
    Breda Kearney

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

    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 & final examination 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 & final examination.

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 about the CQI & IRCA Written Examination?

We are able to offer a new eAssessment option for the lead auditor examinations, which can be completed Remotely or In-Person. Each Learner must obtain 70% or higher in a 2-hour CQI & IRCA eAssessment which is completed securely online (under strict examination conditions).

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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This Course - How Are We Doing

  • 100%

    Our Pass Rate

  • 100%

    Would Recommend Comply Guru

  • 97%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 93%

    Would Recommend 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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