ISO 13485 is a guideline for the medical industry that helps managers ensure medical equipment is in good working order and details the design and manufacturing of devices. It outlines how to build and maintain quality equipment, monitor quality, and maintain device control. ISO 13485 supersedes three documents and is usually coupled with ISO 9001.
The International Organization for Standardization (ISO) created ISO 13485 as a guideline for the medical industry. In particular, ISO 13485 helps managers ensure that medical equipment is still in good working order and also details the design and manufacturing of these medical devices. By setting these regulations and standards, ISO seeks to ensure that medical foundations only use devices that will most help their patients, without causing accidental harm. The 13485 standard supersedes many other standardized documents and is usually combined with ISO 9001, but is not required.
ISO 13485 provides guidance for medical institutions on how to build and maintain quality medical equipment. From a manufacturing perspective, the 13485 standard displays values and information about what makes equipment standard or substandard, with substandard use being illegal or unethical. The design is also standardized to help doctors transition from one piece of equipment to a newer one or another manufacturer, so the medical institution can continue working without having to sit down and get used to new equipment.
From a managerial perspective, ISO 13485 outlines how supervisors and managers should monitor quality and how to maintain it. There are chapters on how to monitor and report equipment sterilization, how to inspect implantable devices, verify device efficacy, and stay current on risk management. For managers or supervisors who aren’t thrilled with having to constantly check equipment, there is a chapter that explains why device control is important and explains that it is standard management responsible for quality assurance.
Three documents are superseded by ISO 13485, either because they are not as up-to-date or because the information within the document has been changed to be more efficient and have higher or more realistic quality standards. The three documents are EN 46001, EN 46002 and ISO 13488. Transitioning to the 13485 standard will help avoid medical institution closure due to low quality equipment and improve patient confidence in the institution.
While not required, ISO 9001 and ISO 13485 are usually coupled. This is because both of these standards pertain to medical devices and technology. The difference is that 13485 is concerned with obtaining and maintaining a set of quality devices, while ISO 9001 is concerned with continuing to improve quality, which goes beyond the maintenance aspect of the 13485 standard.
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