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ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Mar 22, 2024 · ISO 13485 is an internationally agreed upon set of standard quality management system (QMS) requirements for any company involved in the design, production, installation, servicing and manufacturing of medical devices. ISO 13485 was first published in 1996 and has since been revised in 2003 and 2016.
This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and...
EN ISO 13485 is the medical device industry's quality management system (QMS) harmonized standard; written to specify requirements for an organization to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Dec 13, 2023 · ISO 13485 is an international standard created by the International Organization for Standardization (ISO) for organizations that design, produce, install, and distribute medical devices and other related services.
ISO 13485:2016 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices. Certification to the standard requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit.
Jun 8, 2022 · The ISO 13485 standard governs quality management systems for medical devices and related services. It's published by the International Organization for Standardization . ISO 13485 addresses: Quality control. Risk management. Legal compliance. Operational efficiency. Ability to trace and recall products and devices. Process and product improvement.
