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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2026, Vol. 14 ›› Issue (02): 116-121. doi: 10.3877/cma.j.issn.2095-5820.2026.02.004

• Standards, Guidelines and Consensus • Previous Articles    

Interpretation of the health industry standard WS/T 227-2024 "Documental requirements of standard operating procedure for medical laboratory tests"

Renzhi Fan1, Xiaobo Hu2,()   

  1. 1 Anhui Clinical Laboratory Center, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei Anhui 230001, China
    2 Shanghai Clinical Laboratory Center, Shanghai 200126, China
  • Received:2025-12-30 Online:2026-05-28 Published:2026-05-28
  • Contact: Xiaobo Hu

Abstract:

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.

Key words: procedure, standard operating procedure, industry standard, flow chart

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