Standards · Standard or regulation
ISO 13485
Medical devices, Quality management systems, Requirements for regulatory purposes
In plain words
What it covers.
The quality management system standard for organisations that design, make, service or supply medical devices. It requires controlled documents and records, design controls, supplier control, production control, complaint handling, corrective and preventive action, and management review. Certification is the usual route to show regulators the organisation is in control.
Who uses it: Manufacturers, component suppliers, distributors and in-house manufacturing units; hospital engineers auditing suppliers.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Quality manual and document control
- Management responsibility
- Resource and competence
- Design and development controls (clause 7.3)
- Purchasing and supplier control
- Production and service provision
- Measurement, analysis, CAPA and complaints
Key points
What engineers need to know.
- Clause 7.3 sets design controls: planning, inputs, outputs, review, verification, validation and transfer.
- Suppliers must be evaluated and monitored according to the risk of what they supply.
- Records must be kept for at least the lifetime of the device as defined by the maker.
- Complaints and feedback must feed into corrective and preventive action (CAPA).
- It is aligned with ISO 9001 but stricter and focused on regulatory needs.
- The FDA QMSR now incorporates ISO 13485 by reference.
- Supplier audits check this system in practice, not just on paper.
Devices
Devices it applies to.
Each device in the Medical City Device Lab, with its Device Library course on the Platform.
Medical City
Where you practise it.
- S1-M107 The Supplier Audit
- Design Studio design inputs and traceability
- Story Three supplier records (SensorTech)