From June 15th to 17th, the China National Accreditation Service for Conformity Assessment (CNAS) appointed an evaluation team to conduct a three-day on-site review of ISO15189 medical laboratory quality and competence accreditation of Xi'an Tianbo Medical Laboratory laboratory. This is the first re-evaluation of Xi'an Tianbo Medical Laboratory since it first passed the ISO15189 quality system accreditation in 2021.
On the morning of June 15, the leader of the review team presided over the first meeting of this re-review, and read out the purpose, basis, scope and evaluation method, review schedule and division of labor, and declared the confidentiality and fairness commitment on the spot. The general manager of Tianbo Inspection expressed a warm welcome to the arrival of the expert group, affirmed that ISO15189 laboratory accreditation has played a positive role in the improvement of laboratory quality assurance capabilities, and hoped that the review team will put forward more valuable opinions and suggestions on the operation of the quality management system in this review, and promote the further improvement of laboratory quality management and quality assurance capabilities. The director of the experimental center comprehensively introduced the basic situation of the laboratory to the review team, and reported the operation and continuous improvement of the laboratory's quality management system.
During the three-day review period, experts went deep into the laboratory to conduct on-site inspections and went deep into the laboratory quality management system documents according to CNAS-CL02:2012 "Medical Laboratory Quality and Competence Accreditation Guidelines", CNAS-CL02-A001:2021 "Application Requirements of Medical Laboratory Quality and Competence Accreditation Criteria", laboratory quality management system documents and related technical standards, and went deep into various professional groups to review documents, on-site inspection, on-site questions, on-site tests, on-site assessments, etc, laboratory equipment and environment, personnel training and assessment, quality assurance before and after inspection, result report, information system, etc. were carefully inspected, the authorized signatory was assessed, and the suitability and effectiveness of the operation of the laboratory quality management system were comprehensively reviewed. The review experts communicated in detail on the process of specimen collection and handover at the symposium of commissioned testing customers, focusing on the review of service agreements and the continuous improvement of service capabilities.
At the last meeting of this review, the expert group unanimously agreed that Xi'an Tianbo Medical Laboratory has a dynamic, positive, efficient and high-quality team, the laboratory quality management system runs through the whole process and all links of the laboratory work, the overall operation is good, the inspection activities meet the accreditation criteria and technical requirements, and the review team puts forward rectification requirements for the non-conformities found in the review process. Finally, on behalf of the review team, the leader of the review team announced that the on-site re-evaluation was successfully passed.
The successful passage of ISO15189 on-site re-assessment is a full affirmation of the operation and continuous improvement of the quality management system of Xi'an Tianbo Medical Laboratory Laboratory, and it is also a promotion of laboratory quality management, technical ability and service level. The relevant person in charge of Tianbo Inspection said that the non-conformities pointed out by the expert group and the valuable suggestions put forward will be improved one by one, drawing inferences from one by one, focusing on standards, focusing on quality, focusing on technology, and pursuing excellence, constantly improving laboratory quality management, technical capabilities and service levels, and providing accurate and exquisite testing services for clinics and patients.