Supplier Management Key elements & Guidance

A Supplier Management Program should have below elements : Definition of the product’s quality requirements Evaluation of alternative suppliers Selection of the most appropriate suppliers Conduct joint quality planning Co-operation during relationship period Validation of conformance to requirements Certification of qualified suppliers Conduct quality improvement plans Creation and use of supplier rating Guidance for Supplier Read more about Supplier Management Key elements & Guidance[…]

Supplier Qualification Regulations

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[…]