Medical device quality management
What the standard addresses
ISO 13485 sets quality management requirements for organizations involved in medical devices and related services. Its focus includes consistently meeting customer requirements and regulatory requirements that apply to the organization’s role.
Who may use it
Manufacturers, designers, component suppliers, distributors and service providers may need a medical-device-specific quality system. The relevant processes vary with the device, the organization’s activities and the market where the device is supplied.
Risk, records and traceability
Assessment looks at controlled documentation, design and production where applicable, purchasing, validation, traceability, complaint handling, nonconforming product and corrective action. Risk management should be addressed throughout the relevant product life cycle.
What certification means
A certificate relates to the organization and scope stated on it. It is not by itself a product approval, CE marking authorization or clearance from a regulator.
Assessment areas
- Document and record control
- Device risk management and traceability
- Supplier, complaint and corrective-action processes
To check an Astra-issued record, use its certificate number in the public register.
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