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

ISO 13485 Internal Auditor Course

This intensive two day course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organisation. 

In-House Only

To book this course please call us on

01925 377150

COURSE OVERVIEW

This ISO 13485 internal auditor course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organisation.  The course will go through the principles and best practice for effective process audits of quality management systems that meet the requirements specified in the ISO 13485:2016 standard.

We will guide you through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions and you will take part in range of group exercises designed to improve your auditing skills.

COURSE CONTENT

The ISO 13485 internal auditor 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:

  • The history of ISO 13485 and medical device management systems
  • Understanding the new requirements of ISO 13485:2016
  • Planning and preparing for audits
  • Setting audit objectives and creating reports.
  • How ISO 13485 relates to ISO 9001
  • Determine if corrective action has been effectively implemented

WHO SHOULD ATTEND?

The ISO 13485 internal auditor course is aimed at any person that plays a role in maintaining a company’s medical device quality management system.  It is ideal for new auditors as well as existing auditors that need to refresh their knowledge against the new standard requirements.

USEFUL INFORMATION

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 internal auditor course, delegates will be able to:

  • Plan, conduct, report and follow up on an internal audit that measures your QMS against the requirements of ISO 13485
  • Be able to explain the process model for quality management systems, referencing the Plan, Do, Check, Act cycle.
  • Create audit checklists and write follow up reports to improve the effectiveness of your organisations QMS.

RELATED COURSES

ISO 13845 Foundation

ISO 13845:2016 Transition

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.