ISO 13485 Training Courses

Eurofins E&E UK can provide training on the ISO13485 Quality Management Standard for Medical Device Manufacturers, allowing organisations to prepare for, and effectively implement, this critical quality system.

We can offer a range of courses that cover all aspects of ISO 13485 and knowledge levels, from an introduction to the standard through to an extensive, in depth lead auditor course. In summary, our courses cover:

Introducing ISO 13485 Clause by Clause

Understand the essentials of the ISO 13485 Standard, clause by clause, and prepare your organisation to implement ISO13485 with our 2-day training course. This training can be delivered online, or face-to-face (for UK customers) and is ideal preparation for the ISO 13485 Internal Auditor course.

This two-day course explores the requirements of the ISO 13485:2016 Quality Management System standard, clause by clause, and provides a clear understanding of the key principles of the standards as well as the steps needed to implement ISO 13485:2016 within your organisation.

ISO 13485 Internal Auditor

This is a comprehensive 2-day course which provides delegates with the knowledge and skills required to perform an internal audit of a quality management system based on ISO 13485, and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.

Delivered by our experienced Medical Device Certification team, the course includes interactive exercises and workshops as well as a Medical device-based company case study and role play.

ISO 13485 Lead Auditor

Available in Q3 2023, this extensive course teaches the practices and principles of effective quality management systems and audits in accordance with ISO 13485 and ISO 19011. Aimed at professionals who are interested in undertaking first, second or third-party audits, senior management, quality directors and consultants, this course requires a solid knowledge of ISO 13485 (typically from either of the courses above)

Course dates & more information

If you would like more information about this course or to enquire about dates please call 0330 430 3456, email or complete the form below.