ISO 13485:2016 Medical Devices Quality Management Implementation Training Course

Course Aim

Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

Course Description

You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.


Who should attend?

  • Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
  • Management representatives
  • Implementation team members

What will you learn?

On completion, you should gain the knowledge and skills to:

  • Define a quality management system
  • Identify the steps for defining, planning, organizing and scheduling necessary activities
  • Implement an effective quality management system
  • Conduct a base line review of an organization's current position with regard to ISO 13485:2016

How will you benefit?

This course will help you:

  • Understand how to implement a QMS as required by medical device directives
  • Plan the implementation of ISO 13485:2016 within your organization
  • Take the first steps towards ISO 13485:2016 certification
  • Identify how you can better meet regulatory requirements
  • Find ways to increase efficiency and add value through quality management
  • Monitor supply chains to achieve continuous improvement

Prerequisites

You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction course.

What's included?

  • Training course notes for delegates
  • Lunch & Refreshments
  • On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate
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