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

ISO 13485 Transition

This one day course is aimed at those with existing knowledge of OHSAS 18001:2007 that want to understand the changes made in the switch to ISO 45001. The course will explain how you can identify the changes required in your organisation and take steps to ensure you transition smoothly.

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 45001 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

Price

£395 + VAT

Course Duration

1 Day

Start and Finish Times

09:00 – 17:00

What's Included?

Comprehensive delegate folder and certificates. Public courses include lunch and refreshments throughout the day.

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.

Bristol

Dates to be confirmed.

Sunderland

Dates to be confirmed.

Warrington

Dates to be confirmed.

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.