Medical Cable & Harness Package — Supplier Qualification to ISO 13485
Scenario
A medical-device design-and-development company sought a qualified partner for a package of roughly 19 custom cable and harness assemblies at quantities of 10, 25 and 100 units.
Challenge
Before any purchase order, the customer required formal supplier qualification for a regulated medical application — a multi-section evaluation questionnaire with legally signed quality sections, tax documentation, and a full set of quality-system certifications.
Solution
We completed every section of the supplier evaluation, returned the signed quality documentation, and supplied ISO 9001, IATF 16949 and ISO 13485 certificates. We provided transparent BOM-level quotations across all 19 assemblies, with alternative-material options clearly flagged.
Result
We passed the customer's supplier-quality evaluation, and the quotations were accepted as the basis for assembling the initial purchase package.