Risk-Based Supplier Qualification

A compliant Purchasing Controls Program, including Supplier Management, is essential within the Medical Device industry and is relevant in many other industries as well. If not established appropriately, Supplier Management may result in implications ranging from minor supplier nonconformities to major quality related issues. These quality related issues can potentially result in recall initiation, or worse, serious injury or death of a patient / user. This White Paper provides a discussion on a risk-based supplier qualification process that is efficient, effective, and compliant to the applicable requirements.