Compliance · DMX-QA-000
What we require from our supply chain
Damrix Plastics is a distributor. We do not manufacture material and we hold no manufacturing certification. Every standard referenced on this site is held by certified manufacturing partners in our supply chain. This page sets out what we require from those partners, how we verify it and what documentation reaches you with the material.
- Role
- Distributor
- Partner QMS
- ISO 9001 · ISO 13485
- Verification
- Registrar checked
- Retention
- 7 years
Attribution statement
Certifications are held by our partners, verified by us
Materials are sourced through manufacturing partners certified to ISO 9001:2015 and ISO 13485:2016. Certificates of conformance and full lot traceability are provided with every order. Damrix does not represent itself as a certified manufacturer, an FDA-registered facility or an ISO-certified producer.
If a certificate lapses or a partner changes a grade formulation, the affected grade is withdrawn from offer until re-verified.
Standards library
Standard explainers and what we require against each
Each entry states the standard, the scope it covers and the evidence we require from certified manufacturing partners before a grade is represented as conforming.
Quality management systems
We require current ISO 9001:2015 certification from the manufacturing partners producing our stock, verified against the issuing registrar before a source is approved.
Medical device quality management
For materials destined for pharmaceutical and medical device environments, we require our manufacturing partners to operate under a certified ISO 13485:2016 quality management system.
Indirect food additives — polymers
Grades offered for food-contact service must carry a compliance statement from the manufacturing partner referencing the applicable 21 CFR 177 subsection, including the additive and pigment package.
Food equipment materials
We require an active NSF listing reference for grades represented as NSF 51 compliant. Listings are checked against the NSF register, not accepted on a datasheet claim.
Multiple-use plastic materials
For dairy and sanitary process equipment we require conformity to 3-A Sanitary Standard 20-27 from the manufacturing partner for the specific grade supplied.
Biological reactivity
Grades represented as USP Class VI must have in vivo biological reactivity test data traceable to the resin, issued by or on behalf of the manufacturing partner.
Biological evaluation of medical devices
Where a device or fluid-path application requires it, we require ISO 10993 series test summaries — typically -4, -5 and -6 — for the specific grade.
Restricted and declarable substances
Declarations covering RoHS 2011/65/EU and REACH SVHC content are obtained from manufacturing partners on request for any grade we supply.
Document library
Specimen documents and procedure summaries
Specimen certificates and procedure summaries are available for review by quality and procurement groups assessing Damrix as a supplier. Lot-specific documents are issued against actual shipments.
- Certificate of conformance — specimenDOC-COC-SPECPDF · 180 KB
- Certificate of analysis — specimenDOC-COA-SPECPDF · 214 KB
- Food-contact compliance statement — specimenDOC-FCS-SPECPDF · 165 KB
- Lot traceability procedure summaryDOC-TRC-002PDF · 96 KB
- Sample and first-article approval workflowDOC-SAP-001PDF · 128 KB
- Supplier approval and verification policyDOC-SUP-003PDF · 142 KB
Specimen documents are illustrative. Contact us for current controlled copies.
Next step
Request documentation for a specific grade
Tell us the grade and the standard your quality system requires. We confirm what documentation exists, what does not, and what can be obtained from the manufacturing partner.