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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.

Training from LRQA

With LRQA, you can access a wide range of courses to help you further your career and bring improvements to the management systems in your organisation. With many learning styles to choose from, our training courses can help you develop and reach your next level. Find out more about Ascend Training Courses from LRQA. 

Your future development

ISO 13485:2016 Internal Auditor.

In-house

If you are looking for a course for four or more people, you may find our in-house option more cost-effective. Contact the team for a quote.