As quality assurance is a top priority for our customers, so too is it also top priority for us. Our Quality Management System is certified to the ISO9001 (Quality), ISO13485 (Medical Devices) and ISO14001 (Environmental) standards. This provides confirmation through an independent standards authority that that we have control over the method of manufacture of your product, and full traceability of any raw materials or purchased parts that are used in the production process.
As your manufacturing partner Smithstown can offer full validation of your product incorporating Production Part Approval Process (PPAP). This includes: Process Mapping, Risk Analysis, First Article Inspections, Process Capabilities, Gage R&R and Process Capability assessment (Cpk, Ppk).