Our quality system is built on three principles: honor the donor, protect the patient, and document everything. Here is what that looks like in practice. 我们的质量体系基于三项原则：致敬捐赠者、守护患者、记录每一步。以下是这套体系在实际运营中的具体体现。
Comprehensive medical & social history review, physical assessment, and documented family consent — conducted by our recovery partners in accordance with AATB-aligned standards. 由组织获取合作方按 AATB 对齐标准完成详细的病史与社会史审查、体格评估，并取得家属的书面知情同意。
Serology and NAT (nucleic acid testing) for HIV, HBV, HCV, syphilis, and other applicable pathogens, conducted in accredited clinical laboratories. 在具备认可资质的临床实验室完成 HIV、HBV、HCV、梅毒及其他相关病原体的血清学与核酸（NAT）检测。
Tissue recovery performed in controlled environments; processing in cleanroom facilities with validated cleaning, sizing, and sterilization or preservation steps. 组织获取在受控环境下完成；加工在洁净车间内进行，包括经验证的清洁、加工规格控制及灭菌或保存步骤。
Temperature-monitored shipment via validated couriers, complete with market-specific import documentation for Hong Kong, Mainland China, and Taiwan. 由经验证的承运人按温度监控要求运输，并根据香港、中国内地及台湾三地的市场规范备齐进口所需文件。
Each allograft carries a unique ID traceable from donor through hospital. Hospitals receive usage forms for recipient registration and post-implant reporting. 每一份移植物拥有可从捐赠者追溯到医院的唯一编号。医院获得使用登记表，以完成受助者登记与术后随访报告。
Our recovery and processing partners follow standards aligned with the American Association of Tissue Banks (AATB) — the global reference for tissue banking. 我们的组织获取及加工合作方遵循对齐美国组织库协会（AATB）的标准——组织库行业的国际参照体系。
Our suppliers maintain ISO 13485 certified quality management systems for the design, production, and distribution of medical products. 我们的供应商在医疗产品的设计、生产与分发环节均维持 ISO 13485 认证的质量管理体系。
As a Hong Kong-based company, we operate under local regulatory expectations for the importation, storage, and distribution of human tissue products. 作为注册于香港的公司，我们严格遵循当地关于人体组织制品进口、储存及分发的监管要求。
We coordinate with licensed importer partners on NMPA registration and filing pathways appropriate for each product category. 我们与持证进口合作伙伴协同，针对不同产品类别对接 NMPA 合适的注册与备案路径。
For Taiwan-bound products, we follow TFDA guidance on human cell and tissue-based products and research-use materials. 对于进入台湾的产品，我们遵循 TFDA 针对人源细胞与组织类产品及科研用材料的相关指引。
Donor-to-patient traceability is a non-negotiable. Every shipment we distribute is documented end-to-end and retained per regulatory requirements. 捐赠者到受助者的全程可追溯是我们的底线。每一批次的文档均实现端到端记录，并按法规要求保存。
If you are a clinician or hospital staff member and have any concern about an Axiom Tissue allograft — packaging integrity, suspected contamination, adverse outcome, or documentation question — please contact us immediately. We take every report seriously and respond within one business day. 如果您是临床医生或医院工作人员，对雅信生物的同种异体移植物存在任何顾虑——包括包装完整性、疑似污染、不良结局或文档问题——请立即联系我们。我们会严肃对待每一份报告，并在一个工作日内予以响应。