Our company has successfully obtained dual certification to ISO 13485:2016 and ISO 9001:2015 on February 24, 2026. This formal recognition confirms the company’s end‑to‑end quality management system for medical device design, manufacturing, and distribution. For international buyers, it means verified compliance with global medical regulatory requirements — without requiring additional on‑site audits. The certification covers our medical tubing and disposable consumables currently in production.
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We integrated our entire sterilization validation protocol into our internal lab — running bioburden testing, ethylene oxide residual analysis, and packaging integrity checks in-house instead of outsourcing to three separate labs. That gave us real-time data control and cut certificate renewal lead time by 60%.
— Head of Quality & Regulatory Affairs, Suzhou Anjun Precision Plastic Pipe Industry Co.,Ltd
What This Means for Your Procurement Workflow
For procurement managers sourcing medical tubing and disposable medical consumables in bulk, this certification eliminates the need to commission independent audits or request annual surveillance report summaries. You can place blanket POs against certified product lines knowing that every shipment includes updated Declaration of Conformity and full material declarations. Documentation packages are provided digitally, no physical binders, no version confusion, and timely updates when revisions occur.
All new product introductions launched after February 2026 will be designed and validated under the certified system from Day 1 — meaning no delayed certification timelines for custom‑built tubing configurations. We’ve also added dedicated bilingual (EN/CN) support channels for buyers who need clarification on test reports or require expedited document issuance. Certificate validity extends through February 23, 2029, with scheduled surveillance audits every six months — all results shared proactively with active customers.
The ISO 13485 and ISO 9001 certificates are valid for three years from February 24, 2026.
