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16hrs Blended Course EUR € 795.00 ★★★★★ 260 Reviews

ISO 13485 Internal Auditor Training is for anyone that wants to be part of the team that performs internal audits of part of their Quality Management System (QMS) based on ISO 13485.

Why Comply Guru?

  • CQI & IRCA Certified Training
  • Industry-leading Blended Methodology
  • Delivered by Experts with Proven Expertise
  • Less Fixed Classroom Time
  • Learn Online from Home or Work
ISO 13485 Internal Auditor Training

Key Course Information

What you need to know?

Our 16hr ISO 13485 Internal Auditor Training course is a blend of 6hrs of highly interactive eLearning theory modules that are completed first before attending 1-day (in-person delivery) or 2 half days (virtual delivery) of skills-based Live Instructor Workshops that focus on practical application in a real life context.

Available Formats:

eLearning

eLearning

Virtual Learning

Virtual Learning

Face to Face Learning

Face to Face Learning

Customized Learning

Customized Learning

Learning Objectives Module Content Entry Requirements Assessment Methodology Course Accreditation Technology Requirements

Learning Objectives

On completion of this course, successful Learners will have the knowledge needed to:

  1. Explain the purpose of a medical device quality management system, of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
  2. Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
  3. Explain the specific quality management-related requirements of ISO 13485
  4. With reference to the PDCA cycle, explain the process-based QMS Model for ISO 13485 and the role of an internal auditor in the maintenance and improvement of Quality Management Systems
  5. Explain the role and responsibilities of an auditor to plan, conduct, report, and follow up an internal audit in accordance with ISO 19011

Module Content

A summary of learning topics within this course include:

  • Purpose, Benefits & Structure of ISO 13485
  • Quality Management Principles
  • Terms & Definitions
  • Documentation Requirements
  • Plan-Do-Check-Act (PDCA)
  • Process-based Quality Management Systems
  • Risk Based Thinking (RBT)
  • Management Commitment
  • Management System Audits
  • Audit Terminology
  • Principles of Auditing
  • Audit Program Management
  • Certification Audit Program
  • Audit Life Cycle
  • Audit Scope, Objectives & Criteria
  • Selection of Audit Location
  • Selection of Audit Team
  • Auditee, Observer & Guides
  • Audit Initiation & Preparation
  • The Audit Plan
  • Audit Documentation

Entry Requirements

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

  • It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 13485)
  • 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.

Fluency in written and spoken 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.

Copy of ISO 13485 (International Standard)

  • It is recommended that each Learner should have a copy of ISO 13485:2016 (International Standard) to reference while completing this course. This is not provided by Comply Guru and without it, this course will be challenging to complete successfully.

Assessment Methodology

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

  • Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for
  • Fully attend the Instructor Workshop as 100% attendance is required
  • Obtain 70% or higher in the graded assessments during the Instructor Workshops

Course Accreditation

CQI IRCA

CQI & IRCA certify this course (No. 2286). Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.

Technology Requirements

For the live workshops during a virtual delivery, we utilise both Zoom and Microsoft Teams.

Learners need to individually have:

  • PC or MAC Computer
  • Reliable Internet
  • Video Webcam
  • Headset or Earbuds
  • Quiet Setting

In relation to the eLearning 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. Read the full technology requirements here.

Pricing & Schedule

Gain an Internationally Accredited Qualification as an ISO 13485 Internal Auditor

Advance your knowledge and enjoy more convenience & flexibility with blended learning.

Secure Payment

Virtual Workshops
Oct 10th-11th, 2023 9am - 2.30pm GMT+1
EUR € 795.00
Virtual Workshops
Nov 29th-30th, 2023 9am - 2.30pm GMT
EUR € 695 EUR € 795.00

Early Bird Till 15/10

Virtual Workshops
Jan 29th-30th, 2024 9am - 2.30pm GMT
EUR € 695 EUR € 795.00

Early Bird Till 15/12

Virtual Workshops
Mar 11th-12th, 2024 9am - 2.30pm GMT+1
EUR € 695 EUR € 795.00

Early Bird Till 26/01

Virtual Workshops
Apr 29th-30th, 2024 9am - 2.30pm GMT+1
EUR € 695 EUR € 795.00

Early Bird Till 15/03

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Frequently Asked Questions

A blended learning course is a hybrid of eLearning modules and classroom modules (in-person or virtual). Each Learner is required to successfully complete interactive eLearning modules in advance of the live workshops that form the second phase of the training.
The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Yes, we permit transfers to a future date (s) provided the request is made at least 30 days in advance of the live workshops you registered for. No refund is possible if less than 30 days’ notice is given. On a case-by-case basis, if we can accommodate a transfer at less than 30-days notice, we will but this cannot be guaranteed.
For the live workshops, we use Zoom and Microsoft Teams. Full details will be shared with Learners upon registering for the training. 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. Read the full technology requirements here.  
Each Learner is entitled to resit the examination once if unsuccessful in their first attempt. There is a small fee applicable for resit examinations. If unsuccessful after a 2nd attempt, you will need to re-register for the full program.
Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, you will not be eligible to continue to the live workshops.
We keep our classes to 10 or 12 maximum depending on the blended course, to ensure you can enjoy breakout rooms, activities and Q&As with the Instructor and other participants.
Yes, we offer in-house training and if you have 5 or more learners that can be trained together, we strongly recommend arranging for in-house training. With this option, there is the possibility of customizing some elements of the training to your organization. Please request a quote and a member of our team will be in touch to discuss this further with you.
Once you have completed the full program, including examination (if applicable), your certificate will be available within 30 business days via your Dashboard once all examination grading has been completed & verified. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020