FD 132 ISO 13485:2016 Foundation Training Course

This is a Kelmac Group® Certified Course and is not a CQI-IRCA certified programme. The course is delivered by Kelmac Group® as a QMS Fundamentals training course based on ISO 13485:2016. Successful completion confirms that you have achieved the intended learning outcomes relating to ISO 13485:2016 QMS Fundamentals.

This course is ideal for individuals who are new to ISO 13485:2016 and want to build a clear understanding of Quality Management Systems for Medical Devices. It is well suited to professionals who need a practical foundation in medical device quality management in order to support the implementation, maintenance, or continual improvement of a QMS within their organisation. It is also appropriate for learners who wish to progress to Internal Auditor or Lead Auditor training at a later stage. No prior auditing experience is required; however, an interest in medical devices, quality management, regulatory compliance, or management systems would be beneficial.

No prior auditor training is required to attend this course. A general interest in medical device quality management and ISO 13485:2016 is sufficient. This course is designed as an entry-level foundation programme, making it suitable for those who are new to the subject.

This course is the right level for you if you are new to ISO 13485:2016 or would benefit from a structured refresher on the standard. It focuses on the purpose, intent, structure, and key requirements of ISO 13485:2016, including how the standard supports an effective medical device quality management system. It is designed as a foundation-level course to give learners clarity and confidence before progressing to more advanced training, such as Internal Auditor or Lead Auditor courses.

This course is delivered as a one-day learning event, and the delivery format will be confirmed at the time of registration. If your cohort is delivered virtually, the training will take place on the Zoom platform, and you will receive the relevant joining instructions, access details, and platform guidance in advance. To participate effectively, you will need a stable internet connection and a laptop, desktop, iPad, or other tablet device that supports the required platform seamlessly, together with an active web camera and audio access.

The course is designed to be practical and insightful, not just a review of clauses and requirements. It connects ISO 13485:2016 requirements to real organisational quality management, process control, product safety, and effectiveness across the medical device life cycle. It also includes guided activities and practical learning to help learners understand how medical device QMS requirements are applied in practice.

This Fundamentals course includes assessment activities designed to support and confirm learning. Where applicable, learners may complete quizzes, practical exercises, or a final assessment as part of the course learning process. Successful completion of the required learning and assessment activities results in course certification.

After completing the course, you will be able to explain the purpose, intent, structure, and key requirements of ISO 13485:2016 in practical and easy-to-understand terms. You will also understand how a medical device quality management system supports product safety, product effectiveness, regulatory compliance, and controlled processes across the medical device life cycle. In addition, you will be better prepared to support QMS implementation and improvement activities, and to progress with confidence into Internal Auditor or Lead Auditor training.

You will receive a Learner Manual with structured coverage of ISO 13485:2016 terminology, key requirements, and relevant supporting content. You will also have access to relevant standards, practical exercises, and supporting learning materials designed to help reinforce understanding throughout the course. All course materials, access details, and joining information will be provided as part of the learning event.

This course helps learners understand not only the requirements of ISO 13485:2016, but also how they relate to real organisational quality management, process performance, and the medical device life cycle. It is designed to provide a practical and structured learning experience, going beyond basic awareness by linking requirements to application in practice. It also supports learners with a strong foundation that can enable smoother progression into auditor training and wider medical device QMS responsibilities.

Yes. At Kelmac Group, our ISO 13485:2016 Foundation Training helps you understand the key requirements and principles of a medical device quality management system. You can use this knowledge to better understand your organisation’s processes, identify areas for improvement, and support the effective implementation of ISO 13485 requirements.

Yes. Our Foundation course is a suitable starting point for organisations preparing for ISO 13485:2016 certification. It provides an overview of the standard and helps employees understand the requirements that need to be addressed as part of developing and maintaining a compliant quality management system.

Yes. At Kelmac Group, we explain ISO 13485:2016 in the context of the medical device industry and related medical device regulatory requirements. The training helps learners understand why the standard places particular emphasis on areas such as device safety and effectiveness, risk management, documentation, traceability, and regulatory compliance.

Yes. The Foundation course can provide a strong starting point for further professional development. At Kelmac Group, learners can progress to more advanced ISO 13485 training, including Internal Auditor and Auditor/Lead Auditor programmes, to develop deeper auditing knowledge and practical skills.

Yes. Our training is relevant to a broad range of organisations involved in the design, development, production, storage, distribution, installation, servicing, or other post-delivery activities related to medical devices. The principles covered can help professionals understand how ISO 13485 requirements apply within different medical device quality management environments.