ISO 13485:2016 Transition & Auditor Refresher

With greater attention on the organization’s ability to meet applicable customer and regulatory requirements, the new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management.

Discover the latest requirements and explore the changes since ISO 13485:2003 and EN 13485:2012. You’ll refresh your auditing techniques and be able to identify the gaps in your current Quality Management System (QMS).

Who should attend?

Anyone involved in planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.

What will I learn?

You will learn about:

  • Key changes and auditing techniques
  • How these changes may impact your current QMS
  • Revised terms, definitions and audit principles
  • Impact of changes from an auditing perspective
  • Developing an internal audit schedule and plan
  • Relationship between ISO 9001:2015 high level structure and ISO 13485:2016

Transition timelines and what resources may be required.

How will I benefit?

This course will help you:

  • Recognize the key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016 and identify how these may impact your organization
  • Update your knowledge of audit principles, practices and terminology
  • Refresh your skills to prepare for an ISO 13485:2016 audit
  • Explore the relationship between ISO 9001:2015 High level structure and ISO13485:2016
  • Make a smooth transition to ISO 13485:2016 and understand what resources may be required

Participate in audit workshop scenarios to apply the skills you’ve learnt.

Next Steps

  • Lead Auditor: ISO 13485 - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
  • Introduction to: CE Marking - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker
  • Medical Devices Risk Management: ISO 14971 - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.