Training – Medical Devices (ISO13485:2016) Foundation

ISO 13485:2016 – Foundation (1 day)

Course overview

This introduction to ISO 13485:2016 course is conducted over 1 day giving delegates the benefit of understanding the importance of ISO 13485:2016 as a new ISO standard and its relationship to the Medical Devices Directives.

This is a great way for delegates to understand the requirements of ISO 13485:2016 and how to apply a risk based approach to an organisation’s Management System. This helps demonstrate its ability to consistently provide products and services which meet customer and applicable statutory and regulatory requirements.

Course Benefits

By attending and completing this course, successful delegates will be able to:-

  • Understand the key purposes and benefits of an ISO 13485:2016 Quality Management System (QMS)
  • Find the best way to develop the QMS of their own organisation using a ‘risk based thinking’ approach.
  • Understand interactions between purchasing, design, development, manufacturing and production control activities within a QMS.

Tutors have extensive QMS design and improvement experience. They are qualified and experienced consultants and auditors with extensive practical management experience across a wide range of business sectors.

Course Objectives

  • Describe the purpose of a QMS to an organisation, with relevance to the 7 quality management principles
  • Identify the purpose and content of ISO 13485:2016 and the differences between this standard, ISO 9001 and ISO 13485:2013
  • Understand the benefits of a QMS and how to implement the system in order to enhance operations within an organisation
  • Understand and interpret the requirements of the ISO 13485:2016 standard

Course Content

  • Background to Quality Assurance and Quality/Medical Management Systems
  • An introduction to ISO 13485:2016
  • The importance, purpose and benefits of applying ISO 13485:2016 to a management system
  • Interpreting the requirements of the ISO 13485:2016 standard
  • PDCA Cycle
  • Process Approach
  • Continual Improvement


09.00 – 17:00


All successful delegates will be issued with a certificate on behalf of QA International (Training) Limited.

Who should attend?

This training programme is specifically designed for students whose role requires an understanding of ISO 13485:2016 in order to evaluate and assess the impact that a QMS has on their organisation. It is also a great introduction to Quality Assurance for those who are looking to gain an understanding about QMS and the processes involved and those currently undertaking or who are about to implement a transition from the 2013 version of ISO 13485.

Course Prices

The fee includes course materials, delegate notes, lunch and refreshments. It does not include a copy of ISO 13485:2016 which you will need for the course.

Fee: £395.

To enquire about this training course, please complete the course enquiry form.  This form can also be used to enquire about holding this course at your premises.

For other enquiries about training, please contact us by telephone on 01325 384272 or email us at


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