本文系统解读WS/T 227-2024《临床检验项目标准操作程序编写要求》的修订背景、核心理念与技术要点，探讨其在临床检验质量管理体系中的定位与实施策略。采用比较分析法，对照2002版与2024版的技术差异，结合ISO 15189:2022及CLSI QMS02指南进行多维度阐释。新标准实现了从“操作规程”到“标准操作程序（SOP）”的理念跃升，构建了包含21项要素的完整编写框架，创新性地引入“步骤－操作”表和“如－则”决策表等防错工具，强化了SOP作为“检测系统必要组成部分”的核心地位。WS/T 227-2024的发布标志着我国临床检验SOP编写进入系统化、规范化阶段，实验室应建立“要素完整、格式统一、动态管理”的SOP体系，以支撑检验质量的持续改进。

This article systematically interprets the revision background, core concepts and technical highlights of WS/T 227-2024 "Documental Requirements of Standard Operating Procedure for Medical Laboratory Tests", and explores its positioning and implementation strategies within the clinical laboratory quality management system. Through comparative analysis, the technical differences between the 2002 and 2024 editions are delineated, and a multidimensional interpretation is conducted in conjunction with the ISO 15189:2022 and CLSI QMS02 guidelines. The new standard represents a conceptual leap from the concept of "operating procedures" to the "standard operating procedures (SOP)". It contains 21 elements that build a complete documental framework, innovatively introduces mistake - proofing tools such as "step - operating" table and "if - then" decision table, and strengthens the core status of SOP as a necessary part of the testing system. The release of WS/T 227-2024 marks that the establishment of clinical inspection SOP in our country has entered the phase of systematization and standardization. The laboratory shall establish a SOP system that is complete in elements, unified in format, dynamically managed, thereby supporting the continuous improvement of inspection quality.