Implementing an audit program can help companies identify effective operations and processes that can be used as process models for other areas. Cross-functional teams can resolve findings that result in faster, more comprehensive corrective actions. Using the audit program as an aid to improving processes has allowed OEC Medical Systems to achieve a compliance level that resulted in a favorable GMP inspection and successful completion of ISO 9001 registration within a three-month period. Medical device manufacturers must keep in mind that their customers are the users of their products. FDA is a regulatory body and is not concerned about how manufacturers fare in the marketplace.
Customers expect a reliable, quality product.
Meeting customer needs, providing a quality product, and providing a reliable product are all sound reasons for manufacturers to implement an effective quality audit program aimed at self-assessment. A quality audit program is the best method for checking a company's pulse. Post them in our Regulatory Discussion Forum .