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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

  • Introduction
  • What is ISO 13485:2016?
  • Benefits of Implementing ISO 13485
  • Applications of ISO 13485
  • First Steps to ISO 13485:2016 Compliance
  • What is a Medical Device?
  • Purpose of a Quality Management System
  • Importance of ISO 13485
  • Basic Principles of ISO 13485
  • Exercise

Module 2: ISO 13485 Clauses 1 and 2

  • Clauses 1 - Scope
  • Clauses 5 - Management Responsibility
  • Clauses 6 - Resource Management
  • Clause 2 - Normative References

Module 3: ISO 13485 Clauses 3 and 4

  • Clause 3 - Terms and Definitions
  • Clause 4 - Quality Management System
    • Clause 4.1 General Requirements
    • Clause 4.2 Document Requirements
  • Exercise

Module 4: Requirements and Quality Systems

  • Requirements and Quality Systems
  • Clause 5
  • Clause 6
  • Clause 7
  • Clause 8
  • Exercise

Module 5: Overview of ISO 13485:2016 Requirements

  • Requirements of ISO 13485:2016
  • General Requirements
  • Documentation Requirements
  • Management Responsibility
  • Resources
  • Product Realisation
  • Infrastructure
  • Risk Management

Module 6: Implementation Phases of the ISO 13485 Frameworks

  • Stages to Implementation
  • Gap Analysis
  • Process Mapping

Module 7: Conducting an ISO 13485 Certification Audit

  • Certification Audits
  • Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

  • Scope
  • Focus
  • Continual Improvement
  • Terminology
  • Differences Between the Standards
  • Similarities Between the Standards

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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 formal prerequisites for attending this ISO 13485 Foundation Training course.

ISO 13485 Foundation Course Overview

ISO 13485 establishes quality management system requirements for organisations that must consistently demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements. Regulatory requirements apply to all organisations, regardless of size or kind, except as clearly defined. These requirements also apply to linked services provided by an organisation where the criteria relate to medical equipment. This training session equips learners with the requirements of medical devices, implementation phases, and conducting an ISO certification audit. Obtaining the necessary quality management skills through this ISO training will help individuals advance in their careers and get higher job profiles.    

In this 1-day ISO 13485 Foundation Training course, delegates will thoroughly understand quality management systems and how to manage medical devices. During this training, delegates will learn about documentation requirements that define the content of medical device files and a description of the project. They will also learn about the gap analysis checklist to assess running procedures and their compliance with ISO 13485. This course will be led by our highly skilled and professional trainer with years of experience teaching ISO courses.  

Course Objectives

  • To evaluate the expectations and requirements of the customers
  • To raise the quality of medical devices manufactured in a company
  • To enhance the organisational ability and meet customer requirements
  • To promote harmonisation of regulatory requirements for manufacturers
  • To improve the credibility and image of a company to represent compliance
  • To develop an automated quality management system and control the quality

After completing this training, delegates will be able to design and develop medical devices and activities associated with them. They will also be able to promote awareness of regulations company-wide and review the management to identify improvements and regulatory requirements.

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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 

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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.

This is our most popular style of learning. We run courses in 1200 locations, across 200 countries in one of our hand-picked training venues, providing the all important ‘human touch’ which may be missed in other learning styles.

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Highly experienced trainers

All our trainers are highly qualified, have 10+ years of real-world experience and will provide you with an engaging learning experience.

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State of the art training venues

We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible

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Small class sizes

We limit our class sizes to promote better discussion and ensuring everyone has a personalized experience

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Great value for money

Get more bang for your buck! If you find your chosen course cheaper elsewhere, we’ll match it!

This is the same great training as our classroom learning but carried out at your own business premises. This is the perfect option for larger scale training requirements and means less time away from the office.

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Tailored learning experience

Our courses can be adapted to meet your individual project or business requirements regardless of scope.

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Maximise your training budget

Cut unnecessary costs and focus your entire budget on what really matters, the training.

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Team building opportunity

This gives your team a great opportunity to come together, bond, and discuss, which you may not get in a standard classroom setting.

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Monitor employees progress

Keep track of your employees’ progression and performance in your own workspace.

What our customers are saying

ISO 13485 Foundation FAQs

FAQ's

ISO 13485 defines the quality management system requirements for organisations that must demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements consistently.
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.
A Quality Management System (QMS) is important for understanding and meeting objectives, collecting process performance outcomes, and improving processes based on objective assessment.
ISO 13485 is beneficial for organisations in identifying roles under regulatory requirements, regulatory requirements applicable to activities, and regulatory requirements within a quality management system.
The design and implementation of quality management systems are influenced by the varying needs and objectives of an organisation, its organisational environment, products, processes, organisational structure, and regulatory requirements.
In this ISO 13485 Foundation Training course, you will learn how to create a culture of continual improvement, ensure employee participation, change and update documents, manage the effectiveness of the quality management system, and other essential topics.
The price for ISO 13485 Foundation certification in the United Kingdom starts from £895
The Knowledge Academy is the Leading global training provider in the world for ISO 13485 Foundation.
Please see our ISO 13485 Training courses available in the United Kingdom

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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