Blended ISO 13485:2016 Internal Auditor Training – CQI & IRCA Certified

★★★★★

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 an in-depth understanding of the process for performing internal audits of part of their QMS

Did you know? This course is delivered both online & in a classroom (or virtual classroom). Each learner must complete a 6hrs online training before attending a classroom-based 1-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 Duration:

  • 16 Hours
Blended ISO 13485:2016 Internal 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

  • 97%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 96%

    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. 2286)

Course DatesLocationCostHoursPublic CourseOnsite/Virtual Classroom
21st July 2020

Virtual Classroom Training

€ 495.00
( + €30 CQI & IRCA Certification Fee )
6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)
29th September 2020

Virtual Classroom Training

€ 595.00
( + €30 CQI & IRCA Certification Fee )
6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)
25th November 2020

Virtual Classroom Training

€ 595.00
( + €30 CQI & IRCA Certification Fee )
6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)
  • 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, benefits and structure of ISO 13485:2016, the 7 principles of quality management and the key audit related terminology of the standard. We will also explore the key concepts that underpin ISO 13485:2016, namely: Plan-Do-Check-Act (PDCA) cycle, process approach and risk management.

  • Module 2 - Introduction to Auditing (Online & Self-Paced)

    In this module we will explore the internal audit requirements as specified by ISO 13485:2016, the key terminology associated with the auditing standard ISO 19011:2018, internal audit program management, the audit lifecycle roles & responsibilities of the auditor and desired auditor behaviours.

  • Module 3 - Audit Initiation and Preparation (Online & Self-Paced)

    In this module we will explore the audit objectives, scope and criteria and the criteria for selection of the audit team. We will also expand on the audit lifecycle by exploring the first two phases namely “Initiate the Audit and Prepare Audit Activities” including preparation of the audit plan and development of the audit checklists.

  • Module 4 - Conducting Audit Activities (Online & Self-Paced)

    In this module we will expand on the audit lifecycle by exploring the third phase of the audit lifecycle, namely conducting audit activities. Topics to be covered will include, opening meeting, communication, audit methods, generating audit findings and the process for grading non-conformities.

  • Module 5 - Audit Report, Close and Follow up the Audit (Online & Self-Paced)

    In this module we will explore the final stages of the audit, namely: documenting the identified non-nonconformities and conducting the closing meeting. We will also explore, the last three phases of the audit lifecycle namely: preparing and distributing the audit report, completing the audit and performing follow up audit activities.

  • Module 6 - Course Introduction (Classroom/Virtual Training)

    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 7 - 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 practice the skills required to prepare the necessary documents for the audit including the audit checklist.

  • Module 8 - Conducting the Audit (Classroom/Virtual Training)

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

  • Module 9 - Report, Close and Follow-Up the Audit (Classroom/Virtual Training)

    In this module we will practice the skills required for conducting the closing meeting, preparing the audit report and verifying that actions taken to address audit findings were effective.

CQI-IRCA-Certified-Course-logoThis course is fully certified by CQI & IRCA (Course No. 2286)

 

In order to successfully complete this blended course, each Learner will need to:
  • Complete the online course and obtain 70% or higher in the final assessment (part 1 of 2)
  • Fully attend the classroom element and obtain 70% or higher in the continuous assessment (part 2 of 2)
  • Breda Kearney

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

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  • John Collins

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

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  • 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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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 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.

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 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.

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 michelle.reinecke-quain@ibec.ie 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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