ISO 9001:2015
Quality management system, certified and audited annually.
Certifications
Audited systems, current certificates, no surprises
Certificates and audit reports are available on request and included in supplier qualification packages.
Registrations
Current certifications
ISO 13485:2016
Medical device quality management for regulated device components.
IATF 16949 (aligned)
Automotive process discipline: APQP, PPAP, MSA, SPC.
ISO 14001:2015
Environmental management system covering waste, energy and emissions.
FDA Registered Facility
Registered establishment for device component manufacturing.
UL Recognized Materials
UL 94 rated resin processing with documented yellow-card compliance.
Compliance
Material & regulatory declarations
RoHS & REACH
Declarations maintained for all processed resins and colorants.
FDA / USP Class VI
Food-contact and medical-grade material handling with segregated storage.
Conflict Minerals
CMRT reporting supported for supply chain disclosure requirements.
ITAR-aware handling
Controlled-document procedures for defense-adjacent programs.
Need our certificate package for supplier onboarding?
Request current ISO certificates, insurance documentation and quality manual excerpts through the contact form.