Introduction to ISO 13485:2016
Understand the medical device quality management system standard and the regulations that rely on it
- Duration
- 4 hours
- Modules
- 5
- Final exam
- 70% to pass
- Certificate
- No expiry
- Lifetime access to the course and your certificate
- Verifiable Certificate of Completion. Certificate does not expire.
- 3 exam attempts
- Progress saved to your account on every slide
About this course
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 you will be able to do
- 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
Course outline
- 1
Management system foundations
What a quality management system is, how ISO 13485:2016 is organised, and what certification does and does not mean.
About 40 minutes, then a module quiz
- 2
ISO 13485:2016 and the medical device regulatory landscape
What the standard is for, how it relates to ISO 9001, how its clauses are organized, and how regulators in the EU, USA and MDSAP countries use it.
About 40 minutes, then a module quiz
- 3
Clauses 4 to 6: system, management and resources
The quality management system itself, its documentation and records, what top management must do, and the people, infrastructure and work environment requirements.
About 45 minutes, then a module quiz
- 4
Clause 7: product realization
Design controls, purchasing and supplier control, production and process validation, and identification, traceability and UDI.
About 50 minutes, then a module quiz
- 5
Clause 8, certification and getting started
Feedback, complaints and vigilance, internal audit, nonconforming product and CAPA, then how certification and MDSAP audits work and how to begin.
About 50 minutes, then a module quiz
Final examination and certificate
20 questions drawn from the course bank. Score 70% or higher to receive your Certificate of Completion.
More ISO 13485:2016 training
- ISO 13485:2016Internal Auditor
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Plan, conduct and report internal audits of a medical device quality management system
- Duration
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- Level
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Lead certification, MDSAP and supplier audits of medical device quality management systems
- Duration
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- Level
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