ISO 9001
Quality management
Quality-system requirements for applicable molding production sites.
Review the production scope, inspection plan, nonconformance process and release requirements for the selected facility.
Quality assurance
Quality & Manufacturing Standards
The right production process starts with the right qualification requirements.
Our manufacturing network brings together plastic injection molding, liquid silicone rubber molding, overmolding and precision mold tooling. We match the production site, quality requirements and inspection plan to each project.
Discuss Your Quality RequirementsManufacturing partner qualifications
Standards within our production network
FECISION coordinates molding projects through manufacturing partners. Certifications apply to the named production facility and its stated scope, not automatically to every FECISION program.
ISO 13485
Medical silicone programs
Medical silicone rubber production within the certified supplier scope.
Match the part, material and manufacturing activities to the facility’s scope. Product approvals, sterility and biocompatibility require separate project-specific evidence.
IATF 16949
Automotive component production
Applicable silicone accessory and plastic-part manufacturing facilities.
Confirm the production location, component scope and customer requirements. Manufacturing certification does not automatically include product design.
QC080000
Hazardous substance management
Hazardous substance process management for applicable silicone production.
Align material declarations and substance controls with the part specification. This standard is not a cleanroom classification or a product test report.
ISO 14001
Environmental management
Environmental management at applicable manufacturing facilities.
Environmental-system certification relates to the stated production activities. It is not a blanket environmental claim for every finished part.
ISO 45001
Occupational health & safety
Workplace health and safety management at applicable manufacturing facilities.
Review the relevant production site and activities as part of supplier qualification and project planning.
These are manufacturing-network summaries, not certificates issued to FECISION. The relevant certificate, current status, production address and scope are checked for the selected program. Supplier identities and certificate copies are not published on this page.
Controlled molding environments
Cleanroom requirements are project-specific
A cleanroom requirement must identify the production area, classification, operating state and inspection date. Quality-system certification alone does not establish an ISO cleanroom class.
For contamination-sensitive silicone or plastic parts, the production route and supporting environmental documentation are reviewed against your specification before a commitment is made.
Explore cleanroom injection moldingFrom drawing to production
What we review for your project
Production site & scope
Match the selected manufacturing facility and its certification scope to the material, part and intended application.
Material & tooling requirements
Agree the resin or silicone grade, drawing requirements, tooling approach and acceptance criteria during DFM.
Inspection & documentation
Define the required dimensional reports, traceability records and any application-specific validation before production.
Share your drawing and quality requirements
Include the material, target volume, critical dimensions, intended application and any required production-site standards.