Our company has established relevant quality control links in strict accordance with ISO13485:2016 quality management system regulations, and set up different quality control points according to the process characteristics of products.
The supplier audit and evaluation management system has been established and effectively implemented for the purchase of raw materials involved in the product. The corresponding quality requirements have been set for different raw materials, and the IQC link has been established to implement quality control for each batch of purchased materials, so as to ensure the consistency and conformity of materials. According to the process of product processing, the IPQC link is established to control the quality of the key and special processes and form the corresponding quality inspection records. According to the requirements of relevant product standards, the OQC link is established to conduct quality spot check and inspection for each batch of finished products;
According to the policy of batch production and batch management, the company's products form separate batch records, establish separate batch records for different batch requirements, and have a special person to audit, and establish batch release control procedures for batch products. The release control of batches meeting the release conditions provides the necessary quality assurance (QA) level for different production batches.
According to the requirements of relevant laws and regulations, the company has established physical and chemical laboratories and microbiological laboratories, and set up 10000 level testing environmental conditions to be engaged in the detection of microorganisms. According to the requirements of product quality control, we have equipped professional testing equipment such as gas chromatograph, image analyzer, electronic tensile machine, etc.
The company has allocated a quality management team with professional knowledge and experience. The personnel engaged in quality management have received irregular internal training and external training, and carried out corresponding assessment. They are allowed to engage in quality management only after passing the assessment.