ISO 13485:2016 Clause by Clause

This two day course has been designed to provide an in depth understanding of ISO 13485:2016.

On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485:2016 compliant quality management system and help maintain on going certification of their organization.

Who should attend?

  • Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485:2016 and need to have a greater understanding of the management system
  • Organizations preparing to put ISO 13485:2016 in place
  • Personnel who have joined an organization who have ISO 13485:2016 and require in depth knowledge
  • Delegates attending the Lead Auditor to ISO 13485:2016 course who do not already have a good knowledge of the standard
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What will I learn?

  • Explain the scope and the structure of ISO 13485:2016
  • Describe the requirements of ISO 13485:2016
  • Explain how to interpret the requirements of the standard within your organization
  • Develop your knowledge of how the requirements of ISO 13485:2016 are established and maintained in an organization
  • Identify the systems that are required to implement an ISO 13485:2016 QMS in order to gain or maintain certification to ISO 13485:2016

How will I benefit?

  • Describe the requirements and structure of ISO 13485:2016
  • Interpret and apply requirements relevant to your organization
  • Appreciate how a QMS can be applied as a framework to produce safer medical devices
  • Evaluate how requirements can be effectively implemented to meet and maintain regulatory compliance

What's included?

You will gain:

  • 14 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments

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. 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 27 November 2020 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 27 November 2020 and delivered within 12 months, via Connected Learning 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. 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.