earticle

영어

Assurance of product quality is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and process design, control of the process ,and in-process and end-product testing. Due to the complexity of today’s medical products, routine end product testing alone often is not sufficient to assure product quality for several reasons, limited sensitivity, destructive testing. Process validation should be performed to assure quality of product through life cycle approach.