| This project provides guidelines for establishing, implementing, and maintaining a supplier quality performance program that meets the needs of an in vitro diagnostics manufacturer and complies with the Food and Drug Administration quality system regulations 21CFR 820, as well as the requirements for the ISO 13485 Quality Management System for Medical Devices. Using the company's enterprise resources planning system, members of the materials department perform non-traditional tasks that make this program unique and successful. In this project, suppliers are seen as business partners essential to the success of the company; thus, extensive efforts are made in the selection and qualification of capable suppliers and when problems arise the company works together with its suppliers to resolve them. The supplier quality management program described in this project includes supplier selection and evaluation, supplier status and rating, supplier audits, and supplier corrective action procedures. |
