The purchasing controls inclusively supplier evaluation, supplier selection and supplier audits are FDA and ISO 13485 requirements. How to act compliant ~
Quality Objectives and Quality Policy, KPIs and Target Values - the focus lies on the QM-Systems's conformity with ISO 9001 and ISO 13485, and above all the respective certificate.
Notified bodies have to perform unannounced audits of quality management systems at least every five years. Find out when you might expect an unannounced audit...