Internal Auditor ISO 13485:2016 Training 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 organization. 

Learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485:2016 and ISO 19011:2018.

An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.

Who should attend?

  • Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
  • Individuals interested in conducting first-party or second-party audits
  • Management representatives
  • Internal auditors
  • Consultants
“We are continually securing new business because of our certification.”

What will I learn?

On completion of this training, participants will be able to:

  • Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
  • Identify the key principles of auditing and auditor responsibilities
  • Plan an internal audit
  • Conduct an effective audit based on process identification, sampling and questioning
  • Determine if corrective action has been effectively implemented

How will I benefit?

  • Maintain compliance with ISO 13485:2016
  • Improve a global benchmark in quality standards 
  • Be confident that your organization can rely on competent auditors
  • Motivate colleagues through CPD and ensure rigorous regulatory internal processes
  • Write factual audit reports and suggest corrective actions

What's included?

  • You will gain 16 CPD points on completing the course
  • This course does not detail the requirements of ISO 13485:2016 so some previous knowledge is required
  • Training course notes
  • Lunch
  • Refreshmensts

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. In the event of a classroom-based course being deemed unsafe, your training booking will be automatically transferred to online delivery using our highly-interactive virtual classroom - Connected Learning Live.

If you have any questions regarding your booking, please contact training@bsigroup.com or call +44 345 086 9000.


Booking a course delivered via Connected Learning Live?

Take advantage of our exclusive offers, only available in July and August 2020*

Book a July or August Connected Learning Live course date and you’re entitled to unlock one of the following benefits:

  • Option 1: Get 50% off a second delegate booking fee
    Offer applicable to public courses delivered via Connected Learning Live in July and August 2020 only. Second delegate must attend the same course date
  • Option 2: Save £500 on a BSI Diploma in Quality Management
    Offer applicable to delegates that have booked a public course delivered via Connected Learning Live in July and August 2020 only

Contact our training team today to find out more and book your place. Call +44 345 086 9000 or email training@bsigroup.com

*Terms and conditions: Applies to all public BSI UK training courses, taking place in July and August 2020 via Connected Learning Live only. Call our training team on +44 345 086 9000 or email training@bsigroup.com for more information. Second delegate must attend the same course date as the first delegate. Moves, changes and cancellations are not permitted. Payment required or invoice issued at the time of bookings. This offer does not apply to BSI re-sellers or Cybersecurity and BRCGS courses. Offer is for new BSI UK training bookings only. Offer is not to be used in conjunction with any other offer. Offer subject to availability of training courses. Bookings are non-transferable. All other terms and conditions for training courses apply.