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

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This CQI, IRCA and Exemplar Global Certified Blended ISO 13485:2016 Lead 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 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? This course is delivered both online (self-paced) & in a virtual classroom with a Live Instructor. Each learner must complete an 16hr online, self-paced training course before attending a virtual classroom-based 3-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:

    45 Hours
  • Format

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

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

Virtual Training Now Available!
Virtual Training Now Available!

Virtual Training Now Available!

CQI & IRCA (No. 2244) & Exemplar Global Certified Course

Course DatesLocationCostHoursPublic CourseOnsite/Virtual Classroom
15th February 2021
16th February 2021
17th February 2021

Virtual Classroom Training

$ 1995
Add-on & Save 50%:
CQI & IRCA Certified Online and Self-Paced ISO 13485:2016 Foundation Course (+ $247.50)
16 Hours (Online & Self-Paced) + 3 Days (Virtual Classroom)
Includes 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).

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 examinations (pre-Virtual Classroom), attend 100% of the virtual classroom sessions & obtain 70% or higher in the eAssessment (final examination) at the end of the virtual classroom portion of the training. 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 about the CQI & IRCA Written Examination?

CQI & IRCA require us to invigilate the final written examinations that apply on lead auditor programs. The examinations must be completed within 180 days at a test centre. Comply Guru would expect to complete any required examinations shortly after the training has been fully completed.

If attending a public course, a public venue (hotel or equivalent) will be organised to host the examination on a specific date & time for all Participants of that program.

If attending a private course, similarly we will organise to host the examination on a specific date & time for all Participants of that program. For international assignments, we may be able to accommodate special arrangements (contact us for further information).

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 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

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

    Clare O'Gorman | August 20, 2020

  • Knowledgeable instructors. Engaging activities despite virtual environment.

    Alison Llave | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 2020

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

    Benedikt Hirt | August 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 | August 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 | August 20, 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 | August 20, 2020

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

    Shane Curran | August 20, 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 | August 20, 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 | August 20, 2020

  • 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 | August 20, 2020

  • 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 | August 20, 2020

  • 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 | August 20, 2020

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

    Agnieszka Paprocka | August 20, 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 | August 20, 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 | August 20, 2020

  • 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 | August 20, 2020

  • Andreas Diplas | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 2020

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

    Stanislav Praslov | August 20, 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 | August 20, 2020

  • An excellent well managed course.

    Deirdre Quigley | August 20, 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 | August 20, 2020

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

    Michael Galvin | August 20, 2020

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

    Claire Aspell | August 20, 2020

  • No

    Aine Ni Obain | August 20, 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 | August 20, 2020

  • Training was very demanding and informative and diversely.

    Hatice Ermis | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 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 | August 20, 2020

  • Thought course was well delivered by instructors.

    Andrew Hogan | August 20, 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 | August 20, 2020

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

    Rob Naslund | August 20, 2020

  • The virtual course very engaging given by experienced auditors.

    Sarah Dolan | August 20, 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 | August 20, 2020

  • Very professional knowledgeable attentive considerate and inclusive.

    Alison Murphy | August 20, 2020

  • 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 | August 20, 2020

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

Before The Virtual Classroom Modules

  • Complete the online (self-paced) 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 Virtual Classroom Modules

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

After The Virtual Classroom Modules

  • Obtain 70% or higher in a 2-hour CQI & IRCA set final examination
Successful completion will entitle each Learner to receive a CQI & IRCA Accredited Certificate of Achievement.
  • 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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  • 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
    Rod Beuzeval

    Rod has worked in Pharmaceutical and Medical Device sectors for over 19 years and holds a degree in engineering.

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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 & final examination 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™

  • LOGO
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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

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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