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─── World Health Organization

WHO PQS: The Yardstick for Global Vaccine Cold Chain Equipment

PQS (Performance, Quality and Safety), established by WHO in 2007, remains the entry ticket for vaccine cold chain equipment to be deployed in low-income countries.

Global·est. 2007·Global standards and pre-qualification for vaccine cold chain equipment

Key strengths

  • Three-axis evaluation (performance, quality, safety) with transparent and reproducible criteria
  • All certified equipment is listed publicly, simplifying procurement decisions
  • Closed loop with Gavi co-procurement: PQS certification → Gavi purchase → global deployment

Transferability to China

For Chinese vendors going abroad, PQS is the recommended first stop. The ~18-month certification cycle pays back with eligibility in 70+ Gavi-supported countries.

Deep dive

背景

WHO PQS 起源于上世纪 80 年代的 EPI(Expanded Programme on Immunization)配套工程。它最初的目标是给联合国系统的疫苗采购建立"可信赖的设备清单",避免低收入国家在采购时被次品淹没。

核心机制

PQS 体系通过 5 类关键指标对疫苗冷链设备进行评估:温度均匀性、保温时长、能耗、机械可靠性、冷启动恢复速度。每一类都有可复现的实验室测试方法。

对中国的启示

对中国的启示有三:第一,标准要敢于公开;第二,认证要敢于驳回;第三,认证要与采购形成闭环。