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

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  • Course Area:

    Medical Devices

  • Course Duration:

    16 Hours

  • Format:

    Blended Course (6hrs Online & Self-Paced + 1-day Traditional or Virtual Classroom)

  • Accreditation:

    CQI and IRCA approved training partner
  • Upcoming Dates:

    18th August 2021
    29th September 202111th November 2021

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  • Individual Pricing:

    595 per person

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    1785.00 (Save 25%)

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This CQI & IRCA Certified Blended ISO 13485:2016 Lead Auditor Training Course (via Blended Learning) 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 internal audits of QMS against ISO 13485:2016, in accordance with ISO 19011:2018.

Did you know? This course is delivered both online (self-paced) & in a virtual classroom with a Live Instructor. Each learner must complete a 6hr online, self-paced training course before attending a virtual 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!

Learning Objectives

On completion of the Blended ISO 13485:2016 Internal Auditor Training Course, Learners will have gained the skills required to:

  • Plan, conduct, report and follow up an internal audit of a quality management system to establish conformity (or otherwise) with ISO 13485 in accordance with ISO 19011

Course Certification

This course is certified by CQI-IRCA (Course No. 2286). Successful completion will entitle each Learner to receive a digital CQI & IRCA Certificate of Achievement.

Assessment Methodology

In order to successfully complete this blended course, each Learner will need to:

  1. Complete the online & self-paced course modules and obtain 70% or higher in the final assessment (MCQ-based) by the required deadline set in advance of the given classroom date you are registered for
  2. Fully attend the virtual classroom element as 100% attendance is required
  3. Obtain 70% or higher in the course continuous assessment during the virtual classroom modules

Course Access & Support

Upon registering for this course, a Learner will be able to avail of the following:

  • Self-Paced Course access up to the start of the virtual delivery
  • Comprehensive Learner Manual (hard copy)
  • Phone & Email Support (Virtual Instructor)
Includes Access Logo

Included BONUS Course: ISO 13485:2016 Foundation Training

Every Learner wishing to complete Internal Auditor training is recommended to first complete our CQI & IRCA Certified Online & Self-Paced ISO 13485:2016 Foundation Course (8hrs) that focuses on providing a comprehensive understanding of Quality Management based on the ISO 13485:2016 requirements and the key prior learning topics for this course! Whether you are new to ISO 13485 or Auditing or an experienced Professional who would benefit from a Refresher, this course is strongly recommended & included for FREE with this course! PLUS, it comes with its own separate certificate! BOOM!

  • 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.

  • Instructor Image
    Breda Kearney

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

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  • Instructor Image
    John Collins

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

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Course Entry Criteria

Before completing this course, each Learner should have the following prior knowledge:

Work Experience (Recommended)

  • It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 13485) or Internal Auditing in advance of registering for this training 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 & final examination 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 & final examination.

Technology 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.

Additional 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
Course DatesLocationCostDurationPublic CoursePrivate Course
18th August 2021

Virtual Delivery

€ 595
Includes: Online ISO 13485:2016 Foundation Course
16 Hours
29th September 2021

Virtual Delivery

€ 595
Includes: Online ISO 13485:2016 Foundation Course
16 Hours
11th November 2021

Virtual Delivery

€ 595
Includes: Online ISO 13485:2016 Foundation Course
16 Hours

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