What does the ISO 13485:2016 mean, and does it matter?

by | Nov 30, 2020 | Industry

Reading Time: 3 minutes

You might have read a company describe itself as ISO compliant, following ISO standardization, or writing about their quality management programs. However, in order to be ISO certified, companies need to implement and constantly adhere to high quality standards for production and high service standards in supply. They also need to seek certification, and maintain standard operating procedures that allow them to continuously operate at this level.

This type of certification means that the company that holds it has invested time and money to ensure they’re offering the highest quality products on the market, compliant with globally agreed upon standards. It means that they have quality management programs in place, they follow ISO standards and they’re ISO compliant, 24 hours per day, 7 days per week. 


Who is/are the ISO?

The International Organization for Standardization, commonly referred to as ISO, is a globally networked cooperative effort to raise quality standards in production. ISO is composed of 165 national standards bodies who “share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.” ISO’s standards are described as “a formula that describes the best way of doing something,” and are agreed upon by experts internationally. 

The standards dictate a number of operational ideals for equity, consumption, security, sustainability, safety and efficiency, based on the knowledge and experience of the experts from each field.  Once a company conforms to the operations and production standards dictated by the ISO, they can apply for audit and earn their certification. ISO certifications require that ISO’s standards are consistently met, in order to retain the certification. The certification process is completed by a private company unaffiliated with the ISO, which helps maintain unbiased standardization integrity. 


What Does 13485:2016 mean?

ISO 13485:2016 is a specific ISO certification for the global quality management standard of medical devices. This certification requires that the company distributing (and/or refurbishing) medical devices meet constant customer and regulatory requirements. The “13485” signifies that this ISO standard is a quality management standard that medical devices specifically must conform to.   

ISO quality standards are re-evaluated every 5 years, and sometimes companies must make changes to remain in certification compliance. When certifications are compliant and audited by outside organizations, they can earn the updated certification. In “ISO 13485:2016,” the :2016 indicates that the last time this standard was updated was in 2016, and this company is compliant and certified based on that year’s standards. Because it has been less than 5 years since 2016, an ISO 13485:2016 company would be certified in accordance with the current quality standards.


Why it Matters

Earning an ISO certification can take months or years to achieve, depending on what standardization processes and procedures are already in place. ISO certifications take time, money, and a commitment to excellence that can be trusted globally. ISO certified companies proactively seek to conform to high standards for product quality in order to help guarantee customer satisfaction and safety. They also demand continuous improvement from their companies and trust in the experts making a global effort to protect and satisfy consumer needs.

DirectMed parts has earned both a 13485:2016 certification for its magnetic resonance imaging (MRI) and computed tomography (CT) parts and service, and an ISO 9001:2015 certification. These certifications mean that DIrectMed operates with the highest quality standards for both part production and supply consistency that allows us to meet constant supply needs without interruption, worldwide. The ISO certification takes away the guesswork and allows us to show you an unadulterated view of our commitment to quality, so that you can trust us to get it right the first time, every time. 

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