Introduce high-quality talents, improve the technical ability level of employees, add large-scale professional equipment, establish standardized quality management system documents, optimize the laboratory environment, and improve the intelligent information system...... After more than two years of preparation, Shanghai Kangli Medical Laboratory successfully passed the on-site review of the evaluation expert group of China National Accreditation Service for Conformity Assessment (CNAS), becoming the first medical laboratory in Jinshan District to pass the ISO15189 accreditation.
ISO15189 (Medical Laboratory – Accreditation of Quality and Competence) was drafted by the International Organization for Standardization ISOTC212 Technical Committee on Clinical Laboratory Testing and in Vitro Diagnostic Testing Systems, and the only authority for ISO 15189 accreditation of medical laboratories in China is the China National Accreditation Service for Conformity Assessment (CNAS). ISO 15189 accreditation is an endorsement and certification of the quality management system of medical laboratories, marking that the laboratory has reached the international level in terms of quality and reliability, and its test results can be mutually recognized among international medical laboratories.
It is understood that Shanghai Kangli Medical Laboratory is located in Zhujing Industrial Park, covering an area of 8,000 square meters, of which the laboratory covers an area of 3,600 square meters. It belongs to Kangli Medical Group, the group also has a GMP factory - Shanghai Kangli Diagnostic Technology Co., Ltd., its professional technical team in Jinshan is nearly 100 people, with 8 in vitro diagnostic reagents and medical device production lines, the maximum output value of 5 billion yuan per year, long-term deep cultivation of pharmacogenomics research and is committed to promoting its clinical transformation and application, and has cooperated with Agena Bioscience in the United States to establish a demonstration laboratory for psychotropic precision medicine. The company's main products and services include psychiatric & neurological drug gene testing, mycobacterial identification and drug resistance testing, chronic disease drug gene testing and other testing items.
For a long time, Kangli Medical has attached great importance to innovation and R&D investment, with an annual R&D investment of more than 40 million yuan. At present, it has obtained the registration certificate of drug joint detection products from the US FDA, and obtained 10 domestic product registration certificates for Class II in vitro diagnostic reagents, and another 160 products have obtained CE certificates. In addition, Kangli Medical also has more than 40 invention patents, a number of SCI articles and other research and development achievements, and has won the honorary titles of "specialized, special and new" small and medium-sized enterprises in Shanghai, national high-tech enterprises, and patent demonstration enterprises in Jinshan District.
In the next stage, the direction of laboratory products will focus on the field of mental illness and tuberculosis. In addition, this year, it will also focus on the development of cognitive impairment in the elderly, adding traditional Chinese medicine intervention methods, and scientifically and effectively helping middle-aged and elderly people to provide personalized solutions from screening, diagnostic reagents and interventions.
Correspondents | Shen Huanlin
Edit | Cheng Jiayu
Editor-in-charge | Yang Li, Chen Weiting