StandardIllustrative imageMedical devices — Quality management systems — Requirements for regulatory purposes
The international quality management standard for the medical device lifecycle, used as the backbone of most MDR technical documentation and supplier audits.
The standard requires a documented quality management system covering design and development, production, storage, distribution, installation and servicing, with a scope defined by the processes the organisation actually performs.
Risk management is embedded throughout rather than treated as a separate activity. Product realisation must apply risk management principles in proportion to the device, and suppliers must be evaluated and monitored according to the risk of the purchased item or service.
Design controls require documented inputs, outputs, verification, validation, transfer to manufacturing and review at defined stages. Changes affecting the device must be assessed for their effect on regulatory compliance before implementation.
The standard expects a feedback loop from production and post-market data into corrective and preventive action, with traceability from complaint through investigation to any resulting design or process change. Certification is granted for a defined scope and maintained through surveillance audits.
Important: this page is an editorial summary for demonstration purposes. It is not legal advice and does not replace the official text. Always rely on the consolidated version published in the Official Journal of the EU and on qualified regulatory advice.