ISO 13485:2016
Introduction to ISO 13485:2016
Understand the medical device quality management system standard and the regulations that rely on it
Introduction · 4 hours · Certificate does not expire
ISO 13485:2016 is the quality management system standard that medical device regulators in the European Union, the United States, Canada, Australia, Brazil, Japan and many other markets rely on. Whether you design, manufacture, distribute, import or service devices, your organization is expected to run a system that meets it.
This course explains what the standard requires in plain language. You will see how it differs from ISO 9001, how its five requirement clauses fit together, and how the EU MDR and IVDR, the FDA Quality Management System Regulation and the Medical Device Single Audit Program each use it.
You will then work through clauses 4 to 8: the system and its documentation, management responsibility, resources, product realization including design controls and process validation, and the post-market processes of feedback, complaint handling, vigilance reporting, nonconforming product and CAPA.
The final module explains how certification and MDSAP audits work and gives a practical sequence for an organization starting out. Each module ends with a short quiz, and the course closes with a final examination.
What people learn
- Explain the purpose of ISO 13485:2016 and how it differs from ISO 9001
- Describe the structure of the standard and the content of clauses 4 to 8
- Relate the standard to the EU MDR and IVDR, the US FDA QMSR and MDSAP
- Identify the documented procedures and records the standard requires, including the medical device file
- Outline design and development controls, supplier controls, process validation and traceability requirements
- Describe how complaints, vigilance reporting, nonconforming product and CAPA work together
- Explain how certification bodies and MDSAP auditing organizations audit against the standard