This intensive two day 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.
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.
Start and Finish Times
09:00 – 17:00
Comprehensive delegate folder and certificates. Public courses include lunch and refreshments throughout the day.
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.
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.