In ISO 13485, a risk-based approach is a cornerstone for ensuring the effectiveness and compliance of a Quality Management System (QMS). This approach means that actions, controls, and evaluations be proportionate to the risks associated with specific processes,...
Are Supplier Audits Required? No Neither ISO 13485 nor FDA 21 CFR explicitly require supplier audits, although supplier audits are one mechanism of qualification. The requirements established in FDA and ISO rules are: • Companies must define evaluation and selection...