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Course Information

ISO 13485 Foundation Course Outline

The following topics will be taught during this course

Module 1: Introduction to ISO 13485:2016

  • What is ISO 13485:2016?
  • Importance of ISO 13485 for an organisation

Module 2: An Overview of ISO 13485:2016 Requirements

  • General requirements
  • Documentation requirements
  • Management responsibility
  • Resources
  • Product realisation
  • Infrastructure
  • Risk management

Module 3: Implementation Phases of the ISO 13485 Frameworks

  • Stages to implementation
  • Gap analysis
  • Process mapping

Module 4: Conducting an ISO 13485 Certification Audit

  • Certification audits

Module 5: The relationship between ISO 13485 and ISO 9001

  • Scope
  • Focus
  • Continual improvement
  • Terminology
  • Differences between the standards
  • Similarities between ISO 13485 and ISO 9001

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Who Should Attend the ISO 13485 Training Course?

This course is intended for:

  • Members of medical devices quality team
  • Auditors
  • Professionals from the medical device industry
  • Those involved in the implementation of the ISO 13485 standard 
  • Those involved in operations related to a Quality Management System for Medical Devices

Prerequisites

There are no prerequisites for this course.

ISO 13485 Foundation Course Overview

The Knowledge Academy's ISO 13485 Foundation course introduces the updated 2016 version of the ISO 13485. This includes: "Medical Devices Quality Management Systems - Requirements for Regulatory Purposes” - The international reference standard for quality systems for medical device manufacturers in regulatory systems across the globe. During this training experience, delegates will learn the goals and objectives of ISO 13485 and how to implement and manage a Medical Devices Quality Management System (MDQMS). Topics will cover MDQMS policy, processes, performance measures, management commitment, management review, internal audit, and continual improvement. The course aims to ensure that upon completion, delegates will understand the features and functionality of MDQMS, and be able to recognise the connection between ISO 13485 and other standards and regulatory frameworks.

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What's included in this ISO 13485 Training Course?

This training course includes:

  • The ISO 13485 Foundation Examination
  • The Knowledge Academy ISO 13485 Foundation Manual 
  • Certificate
  • Experienced Instructor 
  • Refreshments 

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ISO 13485 Foundation Exam

In order to complete this ISO 13485 Foundation training course, delegates will need to pass the associated examination. The exam is:

  • Multiple choice questions
  • Duration of 40 minutes
  • 50% pass mark
  • Closed book

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Why choose us

Ways to take this course

Our easy to use Virtual platform allows you to sit the course from home with a live instructor. You will follow the same schedule as the classroom course, and will be able to interact with the trainer and other delegates.

Our fully interactive online training platform is compatible across all devices and can be accessed from anywhere, at any time. All our online courses come with a standard 90 days access that can be extended upon request. Our expert trainers are constantly on hand to help you with any questions which may arise.

What our customers are saying

Frequently asked questions

FAQ's

Please arrive at the venue at 8:45am.
We can provide support via phone & email prior to attending, during and after the course.
Delegate pack consisting of course notes and exercises, Manual, Experienced Instructor, and Refreshments
This course lasts for 1 day.
Once your booking has been placed and confirmed, you will receive an email which contains your course location, course overview, pre-course reading material (if required), course agenda and payment receipts
The price for ISO 13485 Foundation certification in Canada starts from CAD1295
The Knowledge Academy is the Leading global training provider in the world for ISO 13485 Foundation.

Why choose us

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Best price in the industry

You won't find better value in the marketplace. If you do find a lower price, we will beat it.

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Many delivery methods

Flexible delivery methods are available depending on your learning style.

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High quality resources

Resources are included for a comprehensive learning experience.

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"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

Joshua Davies, Thames Water

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