3.3. Vendor Management
The process for the evaluation, selection and re-evaluation of suppliers providing completed devices, components, materials, accessory devices, and global cloud services to ensure all the products and services meet the specifications.
Supplier Re-Evaluations
Supplier Audits
SCARs
Supplier Initiated Changes (SICRS)
Periodic assessment of suppliers to ensure their continued compliance and ability to meet the medical device manufacturer's requirements.
On-site evaluations of suppliers to verify their manufacturing processes, quality systems, and overall compliance.
Supplier Corrective Action Requests to address any identified nonconformities or issues with supplied materials or components.
Review and approval of any changes proposed by suppliers that may impact products or processes.