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

★★★★★

Overview

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 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. 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 a classroom!

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

  • 16 Hours

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    Our Pass Rate

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    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

This course is CQI & IRCA Certified (Course No. 2286)

Start Date Location Cost Duration Onsite
Anytime

Anywhere


6 Hours (Online) + 1 Days (Classroom)

Includes Online ISO 13485:2016 Foundation [Additional Course]

Available from June 1st, each Learner will receive access to 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 included to ensure each Learner is well prepared, meets the prior learning requirements & gets the most out of their training!

  • Part 1 = Modules 0 - 5 (Online)

    In order to attend this training, each Learner must successfully complete the Online ISO 13485:2016 Internal Auditor Knowledge & Theory Course (6hrs) which consists of 5 modules (online).

  • Module 6 - 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 7 - 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 practice the skills required to prepare the necessary documents for the audit including the audit checklist.

  • Module 8 - Conducting the Audit (Classroom)

    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)

    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.

This 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

  • 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 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.

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