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

Additional course options

  • Discover our ISO 13485 Qualifications - Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses, exams and demonstrating practical application. Find out more

  • In-house training - If you have a group of people to train an expert tutor can deliver training at your premises. Want to know more? 
    Request a quote for in-house training

 


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

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. We’ve been working with all our venues to ensure that COVID secure measures are in place and a member of our team has visited each venue to personally check things over. Enhanced cleaning procedures have been implemented, food and beverage offers adapted, and meeting room layouts have been modified to enable socially distanced events – with anti-bacterial gel and wipes readily available.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.


Save on your learning journey with the BSI Training Academy*

With BSI training online, you can unlock discounts when booking your learning pathway, helping you shape your next few weeks, months or years of development – whilst saving in the process.

Make the most of your training budget by booking your next 2 or more courses with BSI before 31 March 2021 and you’ll save:

  • 15% off your next course

  • 20% off your second course

  • 25% off your third course

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, booked before 31 March 2021 and delivered within 12 months, via live online training only. Call our training team on +44 345 086 9000 or email training@bsigroup.com for more information.  Discounts applicable when booking 2 or more courses. Bookings must be made at the same time to qualify. 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. This offer does not apply to BIM qualifications, where existing course packages are available. Offer is valid 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.