Introduction to ISO 13485 Course - QCS International

part of the phsc group

ISO 13485:2016 Foundation Course

Our ISO 13485:2016 Foundation Course is the standard specific to quality management systems to ensure regulatory compliance for medical devices.

This practical and interactive 1-day course can help you to understand the key fundamentals of ISO 13485, what an effective Quality Management System should look like, and how this can be applied to your organisation.

You can view our upcoming course dates below, or get in touch to learn more.

Upcoming Courses

  • How to cut through the ‘ISO speak’ to give you a practical understanding of ISO 13485:2016.
  • Myths of system documentation: What you actually need to run your system.
  • Key System Elements: How to implement ISO 13485 into your business, not your business into ISO 13485.
  • The links between ISO 13485 and the Medical Device Directive and CE Marking.

This course is for anyone who wishes to gain an insight into how ISO 13485 and quality management systems can be applied to medical device manufacture. Specifically, this course is aimed at:

  • People new to ISO 13485
  • Anyone with responsibility for quality management in Medical Device manufacturing
  • Anyone who needs understanding of the system to perform their job in a MD-QMS
  • Anyone about to attend one of our medical device auditor courses.

For those who have already completed this course, we also offer an ISO 13485:2016 Internal Auditor Course and our ISO 13485:2016 Lead Auditor Course.

This course will give you a good practical understanding of quality management systems and ISO 13485:2016.

Completion of the course will help you and your organisation to identify gaps in your quality management system as a basis for improvement, helping you to maintain your regulatory compliance and system effectiveness.

Our experienced trainers will also guide you through ISO 13485:2016 so that you have a clear understanding of what it is your certification body is looking for during their next audit.

Course Cost

Early Bird Price £385 + VAT
Available as In house course

Our Approach to Training Courses

We believe that learning becomes easier and more effective if you, as a delegate, feel more involved and participate. As we lead the engaging training experience, we actively encourage thought, analysis, and involvement from participants to ensure you gain greater insight and understanding.

IRCA Approve Training Partner

We are proud to be an IRCA approved training partner and this course is CQI and IRCA certified (2425). Our company and our trainers undergo intensive inspection and assessment every year with the International Register of Certificated Auditors (IRCA). This means that the qualifications obtained from completion of this course are valid and will be recognised by your customers and certification body.

If you would like further information on this training course, you can speak to our experts by calling

01236 734447

or by using our enquiry form below.

Early bird discounts are obtained by reserving a place and paying the discounted fee at the time of booking or invoice date. Two for less discounts are available for two or more people from the same organisation attending the same course, making the reservation at the same time and paying the discounted fee by the invoice date. For all discounts no cancellation refunds are available but transfer may be possible with at least 15 days notice.

IRCA Recommends

"An essential pre-requisite to internal auditor and lead auditor training. This course will give delegates an underpinning knowledge of the management systems and the requirements of the management system standards. This course is recommended for delegates who require a general understanding of the requirements of the standard."