On May 8, 2026, Zechin Bio officially received the ISO 13485:2016 certificate, covering the full lifecycle of R&D, manufacturing, sales and after-sales of agarose, chromatography media and bio-separation media.

ISO 13485 is the most rigorous quality management standard for the global medical device industry. Compared to ISO 9001, it imposes stricter requirements on document control, risk management, design verification and traceability. This certification confirms Zechin Bio's leadership in:

• Production environment: 10,000 m² GMP cleanroom with real-time monitoring of temperature, humidity, pressure differential and particle counts
• Traceability: Unique batch IDs from raw material to finished goods, with 30-year full-chain traceability
• Risk management: ISO 14971-based lifecycle risk management with mandatory design reviews for critical process changes
• Customer response: Complaint response ≤ 24h; serious complaints trigger CAPA within ≤ 4h

This certification is not only international recognition of the existing QMS, but also lays the compliance foundation for the company to expand its IVD raw materials business and enter the supply chains of major European and American diagnostic reagent manufacturers over the next 3 years.

Zechin Bio will continue to invest in QMS, with plans to complete ISO 14001 and ISO 45001 certifications by 2027.