June 21st to 23rd, 2024, the China National Accreditation Service for Conformity Assessment (CNAS) and the expert evaluation team for the National Inspection and Testing Institution Qualification (CMA) conducted a two-day combined CNAS/CMA recertification, expansion, and change site assessment at Shanghai Biomaterials Research and Testing Center .
The review meeting was presided over by Shi Yanping, the leader of the CNAS/CMA review team, who provided detailed explanations on the basis, scope, methodology, and principles of the on-site review, as well as the arrangements for the review work. Director Liu Xin of the Center presented a report to the review team, outlining the Center's basic situation, the operation of its management system, and its preparations for the inspection.
During the review period, the expert review team, adhering to the requirements of CNAS-CL01:2018 Accreditation Criteria for the Competence of Testing and Calibration Laboratories, CNAS-CL01-A004:2018 Application Notes for the Accreditation Criteria for the Competence of Testing and Calibration Laboratories in the Field of Medical Devices Testing, and other relevant accreditation rules and documents, conducted a comprehensive review and evaluation of the organization's status, personnel capabilities, premises and environment, equipment and facilities, and management system through various methods such as inspecting laboratory instruments, facilities, and environmental conditions, reviewing system documents and proficiency testing results, spot-checking inspection reports and original records, conducting on-site tests and operational demonstrations, posing questions on-site, and assessing authorized signatories.
After two days of comprehensive, orderly, and meticulous on-site review, the expert review team unanimously concluded at the final review meeting that the Shanghai Research and Testing Center for Biomaterials had a well-functioning quality system and technical capabilities that met the corresponding technical specifications and standards, and agreed that the Center had passed the combined CNAS/CMA recertification, expansion, and change on-site review.
On behalf of the Center, Director Liu Xin expressed gratitude to the hospital leadership, relevant functional departments, and all the review experts for their trust and support. He noted that this review was a comprehensive examination of the Center's testing level and technical capabilities. The Shanghai Research and Testing Center for Biomaterials would seize this opportunity to conscientiously implement improvement suggestions, comprehensively address existing issues, continue to uphold the quality policy of science, fairness, integrity, and service, continuously expand and enhance its professional technical capabilities, provide professional medical device biological safety evaluation and testing services for domestic and foreign enterprises, universities, and research institutes, promote the clinical transformation of domestically innovative medical devices, contribute to the high-quality development of the hospital, and benefit human health.
