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ISO 13485:2016 – Medical Device Translations

ISO 13485 specifies the requirements for quality management systems within the medical devices sector. By following these requirements, organisations can demonstrate their ability to meet customer and regulatory requirements, improving the overall quality of medical devices. Under this standard, the term ‘medical device’ encompasses any instrument, apparatus, device, machine, equipment or reagent for in vitro use. It also includes any computer programs or materials that are considered medical devices.

This international standard outlines the manufacturer’s obligation to monitor and control both internal and outsourced processes that can affect the final quality of their products. As well as medical device manufacturers, this standard is also aimed at suppliers and third-party vendors providing them with products or services. These external organisations could be involved at any stage of a medical device’s life cycle, from design, development and production to storage, distribution and installation. Even those who service the medical device must adhere to this standard.

Similar to ISO 9001:2015 for quality management systems, the key difference is that ISO 9001 applies to all sizes and types of organisations. Meanwhile, ISO 13485 applies specifically to medical devices and the organisation’s associated services. Any processes required by ISO 13485:2016 but not performed by the organisation still remain the responsibility of the organisation. These external processes are accounted for in the quality management system by monitoring, maintaining and controlling the processes.

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