ISO 13485 Internal Auditor

The ISO 13485 internal auditor course is aimed at quality professionals working within the medical devices industry that are new to auditing or need to refresh their knowledge.  The course will show delegates how to plan, prepare and then carry out an audit before following up with an audit report that gets results.

In-house only

Face to face learning

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Duration:  1 Day

Course Times:  9am – 4.30pm

Availability:  In-house only

Who should attend?

This course is suitable for quality professionals who are working in the medical devices industry who are new to auditing or need to refresh their knowledge and improve their auditing skills.  The course will cover the awareness of the standard before guiding delegates through the internal audit process, giving helpful tips along the way. 

What You'll Learn

By the end of this course students can expect to have gained an understanding of;

  • The history of ISO 13485 and quality management systems for the medical devices industry.
  • The key clauses and requirements within ISO 13485.
  • How to plan for and then prepare for your audit.
  • Interview techniques that wil help you get the most out of your audit.
  • Using checklists to maintain the consistency of your audits.
  • Writing follow up reports to suggest improvements to your system.

Course Content

The following topics will be covered during the course.

  • The history of ISO 13485.
  • ISO 13485 clauses and requirements.
  • Planning for your audit.
  • Creating an audit schedule.
  • Effective interview techniques.
  • Audit checklist development.
  • Writing audit reports.

What's included?

We provide everything you need so you can concentrate on learning.

  • Workbooks, pens and any necessary training handouts.
  • Certificate of attendance that can be used as evidence of your training.

Bring it in-house

Why In-House?

While there’s nothing wrong with open courses there are some occasions when it makes more sense to bring the training onsite.

  • Lower cost per delegate with in-house training gives you more value and a greater return on your investment.
  • Eliminate the travel, accomodation and food costs that come with sending employees on open courses.
  • In-house training gives you the opportunity to have the course tailored to suit your specific requirements.

Want to discuss your requirements in more detail?

call 01925 377150

info@wrktraining.com

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