Online Training Course - An Introduction to ISO 13485:2016+A11:2021

Introduction

In this training course you will learn about the Quality Management System standard ISO 13485:2016+A11:2021.

This standard identifies what is required to create and manage a Quality Management System that is specific to Medical Devices.

We will go through each clause of the ISO 13485 standard to give you a fully comprehensive overview and understanding of the standard and how it applies to organisations that design, develop, manufacture or distribute medical devices.

This immersive training course will benefit quality assurance professionals starting out with ISO 13485, top management looking to get an overview of ISO 13485, people with a general interest in ISO 13485 and personnel who are involved in contributing to their companies Quality Management System.

Taking part on this training course will give you skills and education in all areas relating to an ISO 13485 Quality Management System. The course is modular based and fully online, allowing for distance learning. Participants can go at their own pace giving the freedom to learn at times suitable for you. Unlike other similar courses there is no live lessons or requirement to attend a venue, this gives full flexibility to the participant to learn during hours that suit them rather than the learning provider. 

The training course contains explainer videos and at the end of each module is a test quiz to embed the learning. At the end of the training course a certificate of completion will be provided. This can go with your training records to show continued learning and competency in understanding knowledge of an ISO 13485 Quality Management System. 

Course Content:

• Module 1 - What is ISO 13485 and its Scope
• Lesson 1 - The Scope of ISO 13485
• End of Module Quiz

• Module 2 - Applicable Clauses of the Standard 
• Lesson 1 - The Clauses of ISO 13485 - Clause 1 to 6
• Lesson 2 - The Clauses of ISO 13485 - Clause 7
• Lesson 3 - The Clauses of ISO 13485 - Clause 8
• End of Module Quiz

• Module 3 - Implementing the Quality Management System
• Lesson 1 - The Quality Policy
• Lesson 2 - The Quality Objectives 
• Lesson 3 - The Quality Manual
• Lesson 4 - Procedures
• Lesson 5 - Work Instructions
• Lesson 6 - Forms & Records
• Lesson 7 - Medical Device Files
• Lesson 8 - Document Control & Approval
• End of Module Quiz

• Module 4 - Managing the Quality Management System
• Lesson 1 - Auditing
• Lesson 2 - Corrective & Preventative Actions
• Lesson 3 - Training & Competence
• Lesson 4 - Supplier Management
• Lesson 5 - Design & Development
• Lesson 6 - Change Management
• Lesson 7 - Complaint Handling & Product Recalls
• Lesson 8 - Feedback
• Lesson 9 - Monitoring & Measurement of Equipment
• Lesson 10 - Monitoring & Measurement of Product
• Lesson 11 - Control of Non-Conforming Product
• End of Module Quiz

• Module 5 - Analysing Data generated from the Quality System
• Lesson 1 - Analysis of Data
• Lesson 2 - Management Review
• Lesson 3 - Continuous Improvement
• Lesson 4 - Summary of Learning 
• End of Module Quiz

Course Length:

 This course will take approximately 3 hours to complete. 

Course Audience:

• Quality Engineers
• Quality Assurance Managers
• Quality Assurance Officers
• CEO, CFO, COO, CTO, President, Managing Directors
• Medical Device Project Managers
• Medical Device Design & Development Team
• Medical Device Software Engineers 
• Medical Device Purchasing Team 
• People with general interest 

Certificate:

Certificate of completion with name of person, date of completion and title of course, signed and dated by our team.