The impact of applying ISO 9001:2000 to the audit program in the pharmaceutical industry

This project is intended to assist my company to transition the internal audit program and system from ISO 9001:1994 to the latest version of ISO (ISO 9001:2000) while insuring compliance with the CFR requirement. The result of this transition will allow the company to have an efficient and robust audit program that meets both the ISO 9001:2000 and the CFR requirements. This process outline was developed to be project specific for the process within the company and related only to medical devices. However the transition was designed so that other sites within my company can use the information in order to meet their transition needs. The process developed is not copyrighted and hence can be used, modified or amended to meet the needs of the different sites within the company.