105 Newton House, Birchwood Park, Warrington, WA3 6FW
01925 377150

ISO 13485 Transition Course

This one day ISO 13485:2016 transition course will go through all of the new requirements and changes in the international standard used in the medical device industry - ISO 13485:2016.

In-House Only

To book this course please call us on

01925 377150

COURSE OVERVIEW

This one day ISO 13485 transition course will go through the new requirements of the international standard used for medical devices – ISO 13485:2016.  The course is aimed at those who are familiar with previous revisions of the standard such as ISO 13485:2003 and ISO 13485:2012.

This course can be tailored to meet your organisations specific learning objectives. For more details please call us on 01925 377150 or email us at info@wrktraining.com.

COURSE CONTENT

The ISO 13485 transition course consists of a mixture of presentations and group exercises. Upon completion of the course you can expect to have gained a detailed understanding of the following areas:

  • Key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016
  • New terms and definitions within the ISO 13485 standard
  • How ISO 13485:2016 relates to the new high level structures used in other management systems such as ISO 9001:2015.
  • Transition timelines and what resources may be required.
  • How to communicate the changes across your organisation.

WHO SHOULD ATTEND?

The course is ideal for quality managers, compliance managers and anyone else working within a role that involves planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.

USEFUL INFORMATION

Course Duration

1 Day

Start and Finish Times

09:00 – 17:00

What's Included?

Comprehensive delegate folder and certificates.

COURSE OUTCOME

By the end of this ISO 13485:2016 transition course, delegates will be able to:

  • Interpret the new requirements and clause changes within ISO 13485:2016 and how they apply to your organisation.
  • Understand the changes from previous revisions in the medical device standard and how to communicate the changes effectively within your organisation.

RELATED COURSES

ISO 13485 Foundation

ISO 13485 Internal Auditor

To find out how much this course would cost you to hold in-house simply complete the form below for a free, no obligation quote.