What is ISO 13485?

ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals, and other medical settings.

ISO 13485:2016 is based on the ISO 9001 process model approach and is a management system standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing of medical devices and calls for:

• Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realisation
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems

This standard allows companies to reduce safety and legal risks while creating more economical work environments. As an internationally recognised standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies get recognised as more reputable, trustworthy providers. The most recent version of ISO 13485 is reviewed every five years and revised according to the new requirements and needs of the industry.

ISO 13485 has seen a 33.1% increase in worldwide certificates in 2020, showing the growth and importance of accredited certification in recent times.

ISO 13485 references the ISO 9001:2008 standard, not the latest 2015 version. However, ISO 13485 goes beyond ISO 9001 with many controls specific to medical devices.

Many countries now base their regulatory requirements on ISO 9001 and 13485. For example, the U.S. revised Quality System Regulation (FDA 21 CFR 820) incorporates both of these standards.

Additionally, ISO 13485 certification is a common first step for manufacturers seeking compliance with the Medical Device Directive (MDD) United Kingdom (UKCA) and the CE marking process in the European Union.