医学检验智慧实验室建设已由单点功能应用向全过程协同发展，但面临数据治理基础薄弱、组织协同不畅与数据共享利用受限三方面核心问题，制约着从“信息化”向“智慧化”的实质跨越。本文以ISO 15189质量管理规范为基础框架，从内涵特征、发展现状、面临挑战与实施策略4个维度展开分析，据此提出“统一数据底座+场景应用”的分阶段建设路径、“检验主导、信息协同、管理参与”的组织协同机制，以及安全合规与可信共享的数据治理框架。本文将医学检验智慧实验室这一新兴概念从模糊认知推进到可操作的策略设计，为医疗机构智慧化转型提供可落地的策略参考。

The development of smart clinical laboratories has gradually evolved from isolated functional applications toward integrated, end-to-end process collaboration. However, three core challenges remain: weak data governance infrastructure, inadequate organizational coordination, and limited data sharing and reuse. These factors collectively constrain the substantive transition from "informatization" to "intelligentization". This article, grounded in the ISO 15189 quality management framework, conducts a systematic analysis across 4 dimensions: Connotative characteristics, current development status, challenges faced, and implementation strategies. Accordingly, it proposes a phased construction pathway based on a "unified data foundation plus scenario-based applications" an organizational collaboration mechanism characterized by "laboratory-led, IT-coordinated, and management-involved" governance, and a data governance framework that ensures security, compliance, and trusted sharing. The value of this article lies in advancing the emerging concept of smart clinical laboratories from vague understanding to actionable strategic design, offering practical references for medical institutions pursuing intelligent transformation.