ISO 13485:2016 Foundation Course (Self-Paced Online)

What you will learn

• The purpose and structure of ISO 13485:2016 as a quality management system for regulatory purposes
• The clause 4 to 8 layout and why it is not the Annex SL structure used by ISO 9001
• The regulatory role concept: manufacturer, authorized representative, importer, distributor
• Risk management and its link to ISO 14971 across the device life cycle
• The medical device file, design controls, sterile and implantable device requirements, and traceability
• The feedback, complaint handling, and regulatory reporting chain
• How ISO certification works and how organisations achieve and maintain it

Who is this for?

Open to everyone. Ideal for quality and regulatory staff, engineers, production and design team members in medical device organisations, and anyone new to ISO 13485. No prior knowledge required.

An understanding of ISO 13485:2016 is valuable across every part of a medical device organisation. This foundation course enables you to:

• Understand ISO 13485:2016 and speak the language of medical device quality management with confidence
• Contribute to your organisation's quality management system and its certification readiness
• Understand how regulatory requirements shape the QMS, from design through to postmarket surveillance
• Build a solid foundation before progressing to Internal Auditor training
• Earn a globally recognised foundation credential

Why learning online works for you

• Learn anytime, anywhere. Study on demand, on site or off site, whenever it suits you
• Self paced. Move at your own speed and spend more time on the areas you want to master
• Cost effective. No travel, accommodation, or time away from the office to fund
• Lifetime access. Return to the materials whenever you need them
• Built to stick. Interactive, multi format lessons keep you engaged and improve retention

By the end of this course you will be able to:

• Explain the purpose of a medical device quality management system and how ISO 13485:2016 differs from ISO 9001
• Describe the structure of ISO 13485:2016 and how its clause 4 to 8 requirements fit together
• Explain the regulatory role concept and how role drives applicable regulatory requirements
• Describe the risk based approach and its link to ISO 14971, and the meaning of maintaining effectiveness rather than continual improvement
• Explain key elements such as the medical device file, design controls, sterile and implantable device requirements, and traceability
• Describe the feedback, complaint handling, and regulatory reporting chain
• Explain what ISO certification is and how organisations achieve and maintain it

As a bonus, this course explains how ISO certification works. You will learn what it means for an organisation to be certified, the role of accredited certification bodies and accreditation, and how organisations achieve and maintain certification.

This course is designed for anyone who wants a working understanding of the standard, including:

• Anyone new to ISO 13485 or medical device quality management
• Quality, regulatory, design, and production staff who work within or contribute to the QMS
• Managers, engineers, and consultants who need a working understanding of the standard
• Suppliers and distributors to the medical device industry
• Anyone preparing to progress to Internal Auditor training
• Those supporting their organisation towards ISO 13485 certification

There are no prerequisites for this course. It is suitable for complete beginners.

You will need a computer, laptop, or tablet with a reliable internet connection. The course works in any modern web browser, such as Google Chrome, Microsoft Edge, Mozilla Firefox, or Apple Safari. For the best experience, keep your browser updated to the latest version.