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Learn the systems, tools, and techniques to implement and audit against the harmonized Medical Device QMS Standard.
ISO 13485 represents the medical device industry's quality management system (QMS) standard. It specifies requirements for an organization to design and implement a QMS that can consistently meet customer and applicable regulatory requirements.
Familiarize yourself with ISO 13485 and understand how to implement it and/or audit your QMS through our courses and qualifications.
Learn in a way that works for you, whether that's live online, in person, or self-paced with on-demand eLearning.
Our ISO 13485 courses will help you better understand what an Quality Management System (QMS) is, how to implement it, and how to audit your system.
Get in touchIncrease your understanding of ISO 13485 scope, structure and requirements and identify the systems needed to implement a QMS in your organization.
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Learn best practices to improve your QMS audit process compliance to ISO 13485:2016 and ISO 19011:2018.
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Increase your knowledge and develop additional skills to plan, conduct, report and follow-up a compliant QMS audit.
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Our courses are designed to give learners the knowledge and skills needed to add more value to an organization, whilst developing their career.
Raise internal standards and embed best practice.
Grow confidence by filling gaps in knowledge.
Achieve formal learning recognition with a BSI qualification.
We're a full scope Notified Body and UK Approved Body.
We've trained 70% of the top 100 medical device companies.
Access flexible learning in a format that works for you.
The training significantly improved confidence in conducting internal audits, supporting a more structured and effective approach.
“The course is very well-structured and delivered. It provided a clear understanding of the standard, combined with practical techniques that are directly applicable in real situations.”
Speak to our training advisors on +44 345 080 9000.
