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ISO 13485:2016 Implementation

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Introduction

Learn how to design and implement an effective Quality Management System (QMS) based on ISO 13485:2016.

Applicable for those preparing for ISO 13485 certification or those looking to improve the effectiveness of their current management system.

Who should attend?

  • Individuals responsible for their organisation's ISO 13485 based Quality Management System
  • System managers who may in the future be involved in managing an ISO 13485 based Quality Management System.

What will you learn?

  • To implement a QMS based on ISO 13485:2016
  • To develop a quality policy and objectives
  • The need for documenting systems, processes and typical methods
  • Key features of risk assessment
  • Importance and relevance of legislation
  • Design requirements
  • The significance of process and environmental controls (e.g. clean rooms, sterilisation, personnel controls)
  • Plan and manage your internal quality auditing activities
  • Eliminate the causes of problems through effective corrective action
  • Develop an appropriate management review process and implement processes for improving the effectiveness of the system.

What do you need to prepare?

Knowledge of QMS fundamentals.

What’s included?

  • 2.25 CPD hours
  • Training course materials
  • Lunch and refreshments for public attendees only
  • Certificate of attendance.

Your future development

Course length

Two days.

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