Fangchi New Materials has passed the annual surveillance audit of the ISO 13485 medical quality management system.

From May 20 to 21, 2025, the TÜV SÜD audit team conducted the annual surveillance audit of the ISO 13485:2016 quality management system at Shanghai Fangchi New Material Technology Co., Ltd. The two-day audit focused on spot-checking processes including design and development, manufacturing, procurement control, inspection and release, and customer complaint handling within the medical product line.

Fangchi first obtained ISO 13485 certification in 2019 and has undergone annual surveillance audits since then. The audit team consisted of two auditors who reviewed documentation records as planned and visited the production site to observe actual operations. Given the high cleanliness requirements for medical parts, the auditors paid particular attention to cleanliness control in the injection molding workshop, process validation of the debinding and sintering stages, and the sampling plans for final product inspection.

At the closing meeting, the lead auditor stated that Fangchi's quality system documentation is complete, and on-site operations generally comply with procedural requirements. No major non-conformities were found, and the system continues to operate effectively. The audit team also raised two minor non-conformity recommendations: first, the calibration labels on some equipment had expired and were not replaced in time; second, the validation records for a special process of a certain batch of products lacked audit signatures. The head of the company's quality department stated on-site that corrective actions would be completed and evidence submitted within 15 working days.

According to the company's Quality Director, medical parts are a key growth area for Fangchi in recent years, primarily including stapler components and surgical forceps parts. These parts require high surface quality, dimensional accuracy, and biocompatibility. Maintaining the ISO 13485 system is not only necessary to meet customer requirements but also essential for the company's internal management.

It is reported that Fangchi currently produces approximately 20 million medical parts annually, with major clients being several domestic medical device manufacturers. The company plans to develop two new medical MIM parts in the second half of 2025 and initiate preliminary preparations for CE certification, laying the groundwork for entering the European market.