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16hrs Online Course USD $ 995.00 ★★★★★ 29 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?

  • Exemplar Global Certified
  • Self-Paced, On-Demand Learning (24/7)
  • Highly Interactive, Engaging Experience
  • Industry-leading Methodology
  • Designed by Experts with Proven Expertise
ISO 13485 Internal Auditor Training

Key Course Information

What you need to know?

Our industry-leading Online Training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Available Formats:

eLearning

eLearning

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

Exemplar Global

Exemplar Global certify this course under the Recognized Training Provider scheme. Learners will receive a certificate upon completion with their logo on their digital Certificate of Completion.

Technology Requirements

There are recommended requirements for each Learner in wishing to complete any of our 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

Gain an Internationally Accredited ISO 13485 Internal Auditor Certification

Advance your knowledge and enjoy instant access to your course once you register.

Secure Payment

Individual
USD $ 995.00
5% Off
Team of 5
USD $ 4725.00
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Frequently Asked Questions

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.
Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.
This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.
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.
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, a new course license is required (fee applies).
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com
There are recommended requirements for each Learner in wishing to complete any of our 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.
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. 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