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

★★★★★

Overview

This CQI & IRCA Certified blended 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!

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

  • 40 Hours

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!

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

Start Date Location Cost Duration Virtual Classroom
Anytime

Anywhere

$1995.00
16 Hours (Online & Self-Paced) + 2.5 Days (Virtual Classroom)
  • Part 1 = Modules 0 - 7 (Online & Self-Paced)

    In order to attend this training, each Learner must successfully complete the Online ISO 13485:2016 Lead Auditor Knowledge & Theory Course (20hrs) which consists of 7 modules (online).

  • Module 8 - Course Introduction (Virtual 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 (Virtual 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 (Virtual 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 (Virtual 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 13 - Audit Report and Follow Up Activities (Virtual 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).

 

 

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.

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.
  • 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

  • Ivan Whelan

    Ivan has worked in Pharmaceutical, Biotechnology and Medical Devices sectors for over 20 years.

    Read More

  • Rod Beuzeval

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

    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 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

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.

*Fields (all mandatory)