Quality Documents and Supplier Qualification

Aokeray provides product-, material- and order-specific documentation for custom PTFE, FEP and Pebax tubing projects. The exact document package must be confirmed in the quotation, purchase order or quality agreement before production.

A raw-material document, quality-system certificate or third-party test report applies only to its named organization, site, material, test article and stated scope. It should not be interpreted as approval of every Aokeray component or the customer’s finished medical device.

Documents to request during supplier qualification

  • Current quality-system certificate and stated scope, when applicable
  • Supplier questionnaire and manufacturing-site information
  • Named resin grade and supplier material documentation
  • Certificate of Conformance or other order-release document
  • Dimensional inspection report or agreed inspection data
  • Lot or batch identification and label information
  • Packaging, cleanliness and handling requirements
  • Available material compliance or test reports for the named grade
  • Change-notification, retention and traceability requirements agreed in writing

Separate four types of evidence

1. Resin-supplier documentation

Applies to the named raw material and the scope stated by the resin supplier. Confirm the grade, suffix, additives, revision and date.

2. Aokeray quality-system documentation

Applies to the organization, site and activities shown on the current certificate or document. Request the current copy and verify its scope and validity.

3. Supplied-component inspection documents

Apply to the tubing or processed component released against the order, drawing and inspection plan. Define the required measurements, sampling and report format before quotation.

4. Finished-device validation

Biocompatibility, sterilization compatibility, shelf life, clinical use and regulatory approval of the finished device remain the device manufacturer’s responsibility unless a separate written agreement defines another scope.

How to request documents

Provide the product page or part description, drawing number and revision, resin grade, prototype or production quantity, destination country and the exact documents required by your QA or regulatory team. Aokeray will confirm which documents are available, which are order-specific and which require additional review.

Documents that require scope verification

Requests involving ISO certificates, FDA-related statements, ISO 10993 or USP test reports, RoHS/REACH declarations, cleanroom information, sterilization, material compliance or customer-specific questionnaires must be reviewed against the current source document before public or purchase-order use.

Frequently asked questions

Does an ISO certificate mean every product is certified?

No. A management-system certificate applies to the organization, site, activities and scope printed on that certificate. It is not a product approval.

Does an FDA-listed or compliant resin make the finished tube FDA approved?

No. Resin information applies to the named material and stated condition of use. The finished component and medical device require their own specification, evidence and regulatory assessment.

Can a material test report be used for every resin grade?

No. Confirm the exact grade, additives, test article, method, date and report scope.

How do I obtain the current documents?

Send your supplier-qualification checklist and identify the product, material and order stage. Current documents and permitted distribution are confirmed by the responsible quality team.

Engineering and Supplier-Qualification Resources

Request a documentation review

Send the drawing or product reference and your required-document list. Do not send patient data or protected health information.

Request Quality Documents