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

★★★★★
(30 Reviews, Click to view)

Overview

This CQI & IRCA Certified blended 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? This course is delivered both online & in a traditional or virtual classroom. Each learner must complete an 16hr online, self-paced training course before attending a classroom (or virtual) 3-day skills-based training session. Once the training is successfully completed, each Learner will be registered to complete our new eAssessment (CQI & IRCA Lead Auditor Examination) which can be completed remotely or in-person (online) under strict examination conditions. 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 classroom!

Try our free, online ISO 13485:2016 demo course today to see if our training is for you!

  • 40 Hours
Blended ISO 13485:2016 Lead Auditor Training (CQI & IRCA Certified)

Some Companies that have used Comply Guru™

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

Virtual Training Now Available!

Virtual Training Now Available!

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

Early Bird Discounting Available:

Register & Pay 60 days in advance and save € 100

 

Discounts cannot be combined with any other offer.

Course Dates Location Cost Hours Public Course Onsite/Virtual Classroom
29th June 2020
30th June 2020
1st July 2020

Virtual Classroom Training

€ 1295
( + €35 CQI & IRCA Certification Fee )
16 Hours (Online & Self-Paced) + 3 Days (Virtual Classroom)

Limited Places Available

5th October 2020
6th October 2020
7th October 2020

Virtual Classroom Training

€ 1295 € 1195
( + €35 CQI & IRCA Certification Fee )
16 Hours (Online & Self-Paced) + 3 Days (Virtual Classroom)
30th November 2020
1st December 2020
2nd December 2020

Virtual Classroom Training

€ 1295 € 1195
( + €35 CQI & IRCA Certification Fee )
16 Hours (Online & Self-Paced) + 3 Days (Virtual Classroom)

Save 50% on Online ISO 13485:2016 Foundation [Optional]

From June 1st, each Learner will have the option to avail of 50% off 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 offered at a 50% discount at the time of purchase only, to offer each Learner the opportunity to be better prepared, meet the prior learning requirements & get the most out of their training!

  • 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).

 

 

  • 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

  • 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

  • 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

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

    Benedikt Hirt | May 25, 2020

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

    Clare O'Gorman | May 25, 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

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

    Shane Curran | May 15, 2020

  • Have a look at Q18 of this survey....how 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.
  • John Collins

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

    Read More

  • 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

  • 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

  • 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 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.

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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