The quality management system standard for medical device manufacturers.
ISO 13485:2016 specifies requirements for a quality management system applicable to medical device design, development, production, installation, and servicing. Unlike ISO 9001, ISO 13485 emphasizes regulatory compliance requirements and risk management — making it the primary QMS standard for medical device manufacturers seeking regulatory approval in the EU (CE marking via EU MDR), Canada (Health Canada), and other international markets.
Documentation architecture under ISO 13485 is highly structured: the standard requires documented procedures for all key processes, records demonstrating that processes were followed, and evidence that design controls and risk management were applied throughout the product lifecycle. FDA inspections and notified body audits regularly focus on whether documentation demonstrates process execution — not just that processes exist.
Quality manual, documented procedures, work instructions, and quality records requirements.
Competence records, training documentation, and infrastructure maintenance records.
Design planning, inputs, outputs, review, verification, validation, and transfer documentation — aligned with FDA 820.30.
Process documentation, product traceability records, and preservation documentation.
Equipment calibration documentation, measurement system records.
Internal audit documentation, product monitoring records, CAPA documentation, and complaint records.
Templates and implementation resources for ISO 13485:2016 are available through the ELDR Institute Knowledge Hub and via direct request.