ISO 13485 is the international standard for quality management systems specific to medical devices. It sets out requirements for a QMS that demonstrates the manufacturer can consistently meet customer and regulatory requirements applicable to medical devices and related services.
What ISO 13485 covers: management responsibility, resource management, product realisation (design, purchasing, production, traceability), measurement and analysis, and improvement (corrective action, preventive action, complaint handling). It is process-based, so the same standard applies to a single-product specialist and to a multi-product OEM.
What ISO 13485 doesn't do: it does not confer product approval. A manufacturer can be ISO 13485 certified and still need CE marking, FDA clearance, or destination-market registration before placing devices on a given market. It is a QMS standard, not a product standard.
Using ISO 13485 in supplier qualification: verify the certificate (issuing body, scope, expiry); check that the scope covers the products you are buying; layer in regulatory standing as separate evidence. Treat the certificate as necessary but not sufficient — most reputable manufacturers carry it.
Common pitfalls: assuming ISO 13485 implies regulatory approval (it doesn't); treating an expired certificate as still valid; failing to check certifying body legitimacy. Avoid all three.