01
Quality system
Controls connect incoming materials, formulation, manufacturing and final inspection.
- Incoming material control
- Formulation & batch traceability
- Process control
- Dimensional inspection
- Physical-property testing
- Release documentation
Quality & compliance
Evidence matched to the material and application.
WORTH maintains certified management systems and controlled manufacturing while treating compliance as product- and project-specific.
ISO 9001Quality management
ISO 13485Medical devices QMS
Class 100,000Cleanroom
Concept visual · replace with verified WORTH photographyCompany certificationsISO 9001 and ISO 13485
Controlled environmentClass 100,000 cleanroom
Core principleEvidence matched to exact grade and intended use
02
Compliance approach
Selected materials and products have been evaluated against applicable requirements. Documentation is confirmed by formulation and use.
- ISO 10993 where applicable
- USP Class VI where applicable
- FDA food-contact requirements
- LFGB testing
- UL-linked materials or reports
- Customer-specific documentation
03
Important distinction
Management-system certification does not make every formulation universally approved. Contact us to review the exact material, test scope and intended application.
- Request certificate copies
- Request test reports
- Confirm material grade
- Confirm intended use
- Confirm sterilization method
- Define validation plan
Project questions
What engineering and sourcing teams ask us.
Final recommendations depend on the exact application, selected material and agreed project scope.
01Which certifications are held by WORTH?
WORTH holds ISO 9001 and ISO 13485 management-system certifications.
02Do ISO 10993, USP Class VI, FDA, LFGB and UL apply to every product?
No. These tests, listings or compliance documents apply only to the relevant tested material, report scope or application. We confirm applicability before supply.
03Can customers request certificate and test-report copies?
Yes. Available documents can be provided during a qualified project review after the exact material and intended use are identified.
Documentation by application
Confirm the exact grade, test scope and intended use.
Technical data and compliance documentation are supplied according to the selected material or product. We do not treat one test report as universal approval for every formulation.
Review our quality approachStart a technical conversation
Bring us the application, drawing or material challenge.
Our team will review your requirements and recommend an appropriate material, process and development path.