What Is ISO 13485?

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  • Written By: Alex Newth
  • Edited By: Angela B.
  • Last Modified Date: 23 November 2019
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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.


On the managerial side, ISO 13485 outlines how supervisors and managers should check for quality, and how to maintain that quality. There are chapters for how to track and report sterilization of equipment, how to inspect implantable devices, verifying effectiveness of devices, and continually keeping up on risk management. For managers or supervisors who are not enthusiastic about having to constantly check equipment, there is a chapter outlining why checking the devices is important, and explaining that it is a standard management responsible to ensure quality.

Three documents are superseded by ISO 13485, because they are not as modernized or because the information within the document has been edited so that it is more efficient and presents higher or more realistic quality standards. The three documents are EN 46001, EN 46002 and ISO 13488. Transitioning to the 13485 standard will help keep the medical establishment from being closed down because of low-quality equipment and will improve patients' trust in the establishment.

While it is not necessary, ISO 9001 and ISO 13485 are typically coupled. This is because both of these standards deal with medical devices and technology. The difference is that 13485 deals with getting and maintaining a quality set of devices, while ISO 9001 is about continuing to improve the quality, which goes beyond the maintenance aspect of the 13485 standard.


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