The International Organization for Standardization (ISO) created ISO 13485 as a guideline for the medical industry. Specifically, ISO 13485 helps managers ensure medical equipment is still in proper working order, and it also details the design and manufacturing of these medical devices. By setting these regulations and standards, the ISO seeks to ensure that medical foundations only use devices that will help its patients the most, without causing accidental harm. The 13485 standard supersedes several other standardized documents, and it is usually combined with the ISO 9001, but it does not have to be.
ISO 13485 stands as a guide for medical establishments about how to make and maintain quality medical equipment. On the side of manufacturing, the 13485 standard displays values and information about what makes equipment either standard or substandard, with substandard being either illegal or unethical to use. Design also is standardized to help doctors transition from one piece of equipment to a newer one, or one from another manufacturer, so the medical establishment can keep working without having to sit down and get used to new equipment.
