ISO 13485 Foundation - United Kingdom

Technology Services

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Management with adaptable practices

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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
    1. Clause 4.1 General Requirements
    2. 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

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.

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

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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