ISO 13485:2016 Foundation Course
This practical and interactive 1-day course will help you to understand the key requirements of ISO 13485, what an effective MD-QMS should look like, and how this might apply within your organisation.
To celebrate the launch of our new website we are offering this course at a discounted price of £220.00 compared to our normal cost £440! This is a limited time offer and is available for any course on our current programme.
£220.00 +VAT per delegate
Course Details
£220.00 +VAT per delegate
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What will I learn?
This training course will cover the following topics:
- The main clauses and requirements of the standard and how to implement ISO 13485 into your organisation
- How ISO 13485 contributes benefits to your organisation through introducing key controls to reduce risk
- Using ISO 13485 to assist
- How ISO 45001 contributes towards legal compliance
- The actions you need to take to achieve certification
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.
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.

BSI Standards
A copy of ISO 13485:2016 will be available to you during your training. QCS, as an authorised BSI Distributor, can sell you a full, licenced copy of the standard. As a training delegate we can offer you a copy at 25% off the current price. Simply add this when booking your course at checkout and we will send you a link to download your copy.
On the launch of the new QCS website we are excited to offer special discounts on all our training. This ISO 13485 Foundation course will be available for £220, compared to our normal cost of £440! This is available for a limited time and has been applied to all courses on our current programme.
Take advantage of this offer before it’s removed.