认可作为国家质量基础设施的核心要素，在推动我国医学实验室高质量发展中发挥了重要作用。医学实验室通过建立和实施符合国际标准要求的质量管理体系以获得认可，从而提升技术能力，保障检验检查结果的准确性，确保临床决策的科学性。本文系统梳理了我国医学实验室认可工作的主要进展，具体涵盖认可实验室的数量、类型与覆盖领域，以及获认可实验室ISO 15189:2022换版评审情况、认可结果采信现状等方面；同时剖析当前认可工作面临的挑战，涉及ISO 15189:2022标准的深度解读与实施、即时检验（POCT）项目与新技术新方法的认可，以及部分实验室自我改进内生动力不足等问题，并提出针对性的对策思考，旨在为完善我国医学实验室认可体系、推动行业高质量发展提供参考。

As a core element of the national quality infrastructure, accreditation plays a vital role in promoting the high-quality development of medical laboratories in China. By establishing and implementing a quality management system that meets international standards, medical laboratories obtain accreditation, which enhances their technical capabilities, ensures the accuracy of test results, and supports scientific clinical decision-making. This paper systematically reviews the major progress in the accreditation of medical laboratories in China, including the number, types and scope of accredited laboratories, the status of assessment against to ISO 15189:2022, and the current acceptance of accreditation outcomes. It also analyzes key challenges facing current accreditation effort, including the in-depth interpretation and implementation of ISO 15189:2022, the accreditation of point-of-care testing (POCT) and emerging technologies or methodologies, and the insufficient endogenous motivation for continuous improvement in some laboratories. Finally, targeted countermeasure suggestions are proposed, aiming to provide a reference for improving the accreditation system of medical laboratories and promoting the high-quality development of the industry in China.