Blended ISO 13485:2016 Lead Auditor Training (CQI & IRCA Certified)
This CQI & IRCA Certified blended course (online & 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 & in a classroom. Each learner must complete an 16hr online training course before attending a classroom-based 2.5-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 a classroom!
Try our free, online ISO 13485:2016 demo course today to see if our training is for you!
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- 40 Hours
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Gave us 4/5 Stars or higher Overall Training Experience
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This course is CQI & IRCA Certified (Course No. 2244)!
Spend 50% Less Time in the Classroom! Book Your Place Today!
Early Bird Discounting Available:
Register & Pay 60 days in advance and save € 100
Discounts cannot be combined with any other offer.
Save 50% on Online ISO 13485:2016 Foundation [Optional]
From April 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]
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]
In this module we will explore the purpose and benefits of a QMS, Structure of ISO 13485:2016, key terminology related to auditing, Plan-Do-Check Act (PDCA) Cycle, application of risk-based thinking, process approach & controls and the significance of these for the QMS auditor.
Module 2 - Introduction to Auditing [Online]
In this module we will explore the different types of audits including MD-SAP, benefits of accreditation, principles of auditing, audit program management and the audit lifecycle.
Module 3 - Planning the Audit [Online]
In this module we will explore the criteria for selection of the audit team, roles and responsibilities throughout the audit, desired auditor behaviors, determining audit scope, objectives and criteria.
Module 4 - Audit Initiation and Preparation [Online]
In this module we will explore the activities associated with the first two phases of the audit lifecycle. Topics to be covered will include, establishing contact with the auditee, audit feasibility, document review and finally preparation of a risk-based audit plan and development of the audit checklists.
Module 5 - Conducting the Audit [Online]
In this module we will explore the activities associated with the first third phases of the audit lifecycle. Topics to be covered will include, opening meeting, communication, auditee reactions and conflict resolution, audit methods and audit evidence.
Module 6 - Generating Audit Findings and Closing Meeting [Online]
In this module we will explore the final audit team meeting, the steps required to generate and document the audit findings and the process for determining the audit conclusion. We will also review the purpose and agenda for the closing meeting.
Module 7 - Audit Reporting, Completion and Follow-Up [Online]
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 8 - Course Introduction [Classroom]
In this module, an introduction to the classroom element of the blended course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & training delivery.
Module 9 - Planning the Audit [Classroom]
In this module we will explore the key steps that are required to plan the audit using a risk-based approach. We will also 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 10 - Conducting the Audit [Classroom]
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 11 - Generating Audit Findings and Closing Meeting [Classroom]
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 12 - Audit Report and Follow Up Activities [Classroom]
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).
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 course 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 it’s 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 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
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 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
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
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
- Fully attend the classroom element as 100% attendance is required
- Obtain 70% or higher in the course continuous assessment during the classroom element
- Obtain 70% or higher in a 2-hour CQI & IRCA set final examination
- 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.
- 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.
E-Learning System RequirementsThe 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 SystemsWindows 7/10, Mac OSX Sierra, iPad IOS10
Mobile DevicesComply 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 SpeedWe 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
Recommended SettingsWe recommend that the following settings are enabled:
- Pop-ups (in both Internet Browser and security software)
- Latest Version of Adobe Flash Player
- Latest Version of Adobe Acrobat Reader