1、Quality Control System


Company has established quality control system in document form, implement, keep and continuously improve it according to ISO13485, in vitro diagnostic reagent kits practice detailed ruler(trial version) and other law & regulation. Including:


1.1 Management Activity: include documents control, quality record control, establishing quality policy & quality target, set quality management system, identifying responsibility & inter-relation, implementing internal communication, appointing governor representative and carrying on management audit, etc.


1.2 Resource supplying: include identifying necessary resource( such as human resource, basic establishment and working environment), providing required resource and controlling current resource(such as keep the capability of human resource, consciousness forming and training),


1.3 Products realization: include planning, identifying, reviewing and regulating products standard for products realization; establishing and practicing customer communication; purchasing and related activities; manufacturing process and relevant activities; managing watching and measuring machines.


1.4 Measuring, analyzing and improvement process: include customer satisfaction survey, internally auditing for quality system, watching & measuring process and products, controlling non-conforming products, data analysis and process improvement.


Company provides process through the implementation of the identified resource, supply necessary resources for all the process of quality management system. At the same time, through the internal communication, product requirement identification and customer communication, company provides relevant resource to support the effective operation of the process of quality management system and monitor the process. Monitor & measure process, analyze results take necessary measures to achieve the results of process planning and continuous improvement process.