The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.ISO 9001 Is Applicable If now it is accepted that QMSs based on ISO 9001 are useful in controlling the operations of ... We have found this to be a particular problem in our Quality Manual that contains the top level description of our system andanbsp;...
|Title||:||Pre-Production Quality Assurance for Healthcare Manufacturers|
|Author||:||G. William Hough, David A. Rawlings, Michael F. Turner|
|Publisher||:||CRC Press - 1997-06-30|