FSOFT secures ISO 13485:2016 recertification, reinforcing excellence in medical device quality management
From November 3–4 in Japan and November 10–13 in Ho Chi Minh City, FSOFT successfully completed the ISO 13485:2016 recertification audit – the international standard for medical device quality management systems. This marks the second time FSOFT has achieved this certification since first being awarded it in late 2022.
Each year, FSOFT undergoes surveillance audits to ensure validity and continuously improve quality management. The audit scope covered medical device projects under the GHC unit at two sites: Japan and Ho Chi Minh City. The assessment was conducted by SGS, with auditor Mr. Phan Thế Khanh.
According to the auditor’s evaluation, FSOFT demonstrated several outstanding strengths:
* A highly mature Quality Management System (QMS) operating stably with ongoing improvements.
* Clearly defined strategic objectives (KPIs) closely aligned with operational practices and improved annually.
* No recorded complaints related to safety or poor quality during 2024–2025.
* Software design and development projects well-controlled by a professional team.
* Full compliance with ISO 13485 requirements, with continuous maintenance and enhancement.
* Most documentation strictly controlled, ensuring transparency and consistency.
Notably, no significant improvement points were identified during this audit. Nevertheless, FSOFT remains committed to maintaining and leveraging its existing strengths.
This audit also marks a significant milestone as FSOFT has integrated cloud technology into its management processes, enhancing operational efficiency and data management while laying the foundation for future adoption of advanced technologies.
Maintaining ISO 13485:2016 certification not only strengthens trust among existing clients but also opens new collaboration opportunities in the healthcare sector with major partners such as Hitachi, Fujifilm, and other leading names in medical devices. This achievement underscores FSOFT’s internationally recognized quality management capabilities and reaffirms its commitment to continuous improvement to exceed global customer expectations.
