There are various regulations formulated by different agencies highlight as a whole or part the supplier qualification guidelines. few are below. ISO 13485 Clause 4.6.2: Assessment of Sub-contractors–ISO 13485:2003 – Clause 7.4.1 mimics previous clause; standard adds explicit reference to “outsourced process” (4.1) – Clause 7.4.1 – The type and extent of control applied to Read more about Supplier Qualification Regulations[…]