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The Department of Laboratory Medicine at Kunming Tongren Hospital Successfully Passed the ISO 15189 Surveillance Assessment

2026-06-28


From May 21 to 23, 2026, the Department of Medical Laboratory at Kunming Tongren Hospital successfully passed the on-site assessment conducted by the expert review team of the China National Accreditation Service for Conformity Assessment (CNAS), successfully completing the three-day ISO 15189 surveillance assessment for Medical Laboratory Quality and Competence.

The successful completion of the surveillance assessment represents a milestone in the hospital’s high-quality development and marks a new breakthrough in the standardization, quality management, and internationalization of its laboratory testing services.

The on-site assessment was conducted by an expert review team appointed by the China National Accreditation Service for Conformity Assessment (CNAS). The review team was led by Director Sun Zhiqiang from the Fifth Medical Center of the Chinese PLA General Hospital. The expert panel also included Director Liang Xiannian from the Precision Medicine Laboratory of the Institute of Precision Medicine, Kunming Medical University, Director Zheng Rui from The First People’s Hospital of Yunnan Province, Director Lu Sumei from The First Affiliated Hospital of Shandong First Medical University, and Director Li Mo from Guangdong Provincial Hospital of Chinese Medicine.

Following the opening meeting, the expert review panel commenced a comprehensive on-site assessment. Through document review, record inspection, on-site interviews, live testing, morphological assessment, and the evaluation of authorized signatories, the experts conducted a comprehensive assessment of the Department of Medical Laboratory’s quality management system and its implementation.

Meanwhile, the panel visited key clinical departments, including Gynecology & Obstetrics, Orthopedics & Spinal Surgery, Neurology, Nephrology, Endocrinology, and Respiratory Medicine. They held face-to-face discussions with frontline medical staff to conduct a thorough assessment of key aspects, including the implementation of specimen collection standards and related training, critical value reporting procedures and threshold settings, point-of-care testing (POCT) management, the consistency of laboratory test results with clinical diagnosis and treatment, and the alignment of laboratory testing services with clinical needs.

The closing meeting of the assessment was successfully held on May 23. On behalf of the expert review panel, Team Leader Sun Zhiqiang delivered a comprehensive summary of the three-day on-site assessment. He fully affirmed the suitability, adequacy, and effectiveness of the quality management system of the Department of Medical Laboratory at Kunming Tongren Hospital and recognized the department’s achievements in standardization, quality control, and clinical services. He officially announced that the Department of Medical Laboratory at Kunming Tongren Hospital had successfully passed the on-site ISO 15189 surveillance assessment for Medical Laboratory Quality and Competence.