Incoming material
Identify material, supplier records, specification revision, and the checks required before release to production.
Quality Due Diligence
Trust signals buyers can actually audit.
Use this page to define the controls, records, certificate scope, and market-specific checks that must be verified for a quoted product before ordering.
Material document reviewFirst-article criteriaRelease record scopeCertificate status check
Quality Summary
A defensible OEM quality plan identifies the quoted product, specification revision, test method, acceptance criteria, record owner, and approval status. Do not treat a facility statement, certificate category, or supplier document as product-level proof without matching its scope.
Control Flow
Quality checkpoints to agree before production.
The applicable checks and records depend on product type, material, intended use, destination market, and the buyer-approved specification.
First article
Agree dimensions, color, hardness, pack fit, label, leaflet, and written buyer approval criteria.
In-process sampling
Define only applicable visual, physical, chemical, microbial, residual, and packaging tests, including method and limit.
Final release
Agree final inspection fields, quantity and carton checks, release authority, retained records, and buyer handoff files.
Market & Certificate Review
Verify applicability before requesting a badge.
Certification and regulatory routes are product- and market-specific. The checks below are due-diligence prompts, not claims that YUJI or every product holds each status.
Quality-system certificates
Verify the holder, issuing body, standard, covered activities or products, issue date, expiry date, and current status.
United States
Determine device classification, product code, establishment/listing duties, and any exemption limitations. FDA registration or listing does not mean approval. Check FDA guidance.
European Union
Determine which legislation applies before using CE marking; if no rule specifically requires CE, it must not be used. Check EU guidance.
Material and claim files
Match each specification, test report, scheme certificate, or religious claim to the quoted material, finished product, method, and permitted wording.
Evidence Matrix
Turn trust claims into auditable procurement files.
The page avoids unsupported certificate promises and instead states what buyers should request and verify.
Specification and supplier records
Useful for silicone cup/disc material review, pad material selection, and packaging bill-of-material checks.First-article and in-process checks
Specify the applicable dimensions, physical tests, chemical or microbial tests, packaging checks, methods, limits, and record format by product type.QC records and export handoff
Final inspection, quantity, carton labels, packing list, and release records support procurement due diligence.Certificate scans and claim review
Buyers should verify standards, product scope, expiry dates, importer responsibility, and local retail claim rules.Document Pack
What procurement teams should request before ordering.
Ask YUJI to list the exact specifications, certificate scans, test summaries, QC release records, sterilization-related documents, packaging files, carton data, and sample approvals available for the quoted project. Verify scope and approval status before using any file externally.
Important boundary
Document availability is not the same as product approval. Market classification, claims, registration, importer responsibility, and retail compliance must be confirmed for the target country by the responsible parties.