ISO 13485 identifies the requirements for a quality management system to be used by an organisation involved in one or more stages of the life-cycle of medical devices. This can include the following:-
• Design and Development
• Storage and Distribution
ISO 13485 training focuses on a risk based approach to an organisation's management system which demonstrates its ability to consistently provide products and services which meet customer and applicable statutory and regulatory requirements.
To enquire about ISO 13485 training courses please complete the course enquiry form. This form can also be used to enquire about holding any of these courses at your premises.
ISO 13485:2016 – Foundation (1 day).
This course is appropriate for anyone who needs to have an understanding of an ISO 13485 quality management system. Click here for full course details
ISO 13485:2016 – Internal Auditor (2 days).
This two day course is designed for those who want to acquire a sound understanding of the techniques and principles of quality auditing relating to medical devices. Click here for full course details
ISO 13485:2016 – Auditor Transition (1 day).
This course is appropriate for delegates who are looking to understand the changes introduced by ISO 13485:2016 and how to apply them when using auditing skills and techniques. Click here for full course details
To enquire about ISO 13485 courses please complete the course enquiry form. This form can also be used to enquire about holding any of these courses at your premises.
For other enquiries about training, please contact us by telephone on 01325 384272 or email us at firstname.lastname@example.org