https://www.taxtmi.com/article/detailed?id=15952 ISO 13485 prescribes a medical-device-specific QMS that embeds regulatory compliance and lifecycle risk management, mandating documented procedures, record retention, validation of special processes, supplier qualification, traceability and post-market surveillance. It follows a process-based approach similar to ISO 9001 but with stricter documentation, mandatory risk management aligned to device standards, and a compliance-focused objective rather than continual improvement. Integration with ISO 9001 is feasible by adopting ISO 13485 as the core framework and adding strategic and improvement elements from ISO 9001. en-us Mon, 02 Mar 2026 08:38:47 +0530 Mon, 02 Mar 2026 08:38:47 +0530 TaxTMI RSS Generator https://www.taxtmi.com/article/detailed?id=15952 ISO 13485 prescribes a medical-device-specific QMS that embeds regulatory compliance and lifecycle risk management, mandating documented procedures, record retention, validation of special processes, supplier qualification, traceability and post-market surveillance. It follows a process-based approach similar to ISO 9001 but with stricter documentation, mandatory risk management aligned to device standards, and a compliance-focused objective rather than continual improvement. Integration with ISO 9001 is feasible by adopting ISO 13485 as the core framework and adding strategic and improvement elements from ISO 9001. Articles Other Topics Mon, 02 Mar 2026 08:38:47 +0530 https://www.taxtmi.com/article/detailed?id=15952