We are independent & ad-supported. We may earn a commission for purchases made through our links.
Advertiser Disclosure
Our website is an independent, advertising-supported platform. We provide our content free of charge to our readers, and to keep it that way, we rely on revenue generated through advertisements and affiliate partnerships. This means that when you click on certain links on our site and make a purchase, we may earn a commission. Learn more.
How We Make Money
We sustain our operations through affiliate commissions and advertising. If you click on an affiliate link and make a purchase, we may receive a commission from the merchant at no additional cost to you. We also display advertisements on our website, which help generate revenue to support our work and keep our content free for readers. Our editorial team operates independently of our advertising and affiliate partnerships to ensure that our content remains unbiased and focused on providing you with the best information and recommendations based on thorough research and honest evaluations. To remain transparent, we’ve provided a list of our current affiliate partners here.

What Is ISO 13485?

By Alex Newth
Updated May 17, 2024
Our promise to you
About Mechanics is dedicated to creating trustworthy, high-quality content that always prioritizes transparency, integrity, and inclusivity above all else. Our ensure that our content creation and review process includes rigorous fact-checking, evidence-based, and continual updates to ensure accuracy and reliability.

Our Promise to you

Founded in 2002, our company has been a trusted resource for readers seeking informative and engaging content. Our dedication to quality remains unwavering—and will never change. We follow a strict editorial policy, ensuring that our content is authored by highly qualified professionals and edited by subject matter experts. This guarantees that everything we publish is objective, accurate, and trustworthy.

Over the years, we've refined our approach to cover a wide range of topics, providing readers with reliable and practical advice to enhance their knowledge and skills. That's why millions of readers turn to us each year. Join us in celebrating the joy of learning, guided by standards you can trust.

Editorial Standards

At About Mechanics, we are committed to creating content that you can trust. Our editorial process is designed to ensure that every piece of content we publish is accurate, reliable, and informative.

Our team of experienced writers and editors follows a strict set of guidelines to ensure the highest quality content. We conduct thorough research, fact-check all information, and rely on credible sources to back up our claims. Our content is reviewed by subject-matter experts to ensure accuracy and clarity.

We believe in transparency and maintain editorial independence from our advertisers. Our team does not receive direct compensation from advertisers, allowing us to create unbiased content that prioritizes your interests.

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.

About Mechanics is dedicated to providing accurate and trustworthy information. We carefully select reputable sources and employ a rigorous fact-checking process to maintain the highest standards. To learn more about our commitment to accuracy, read our editorial process.

Related Articles

Discussion Comments
About Mechanics, in your inbox

Our latest articles, guides, and more, delivered daily.

About Mechanics, in your inbox

Our latest articles, guides, and more, delivered daily.