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
Review manufacturing-partner certifications, production-site scope and inspection requirements for your injection molding project.
Manufacturing partner qualifications
Manufacturing Partner Certifications
Explore certificate copies from our manufacturing network. Supplier identities are protected in these public copies; the original standards, scope and dates are retained.
View certificatePartner certificate · redacted copy
ISO 13485:2016
Medical device quality management
Production and sales of medical silicone rubber products, excluding activities requiring qualification permits.
- Issued by
- Guangdong Zhonghui Certification
- Valid from
- Printed expiry
View certificatePartner certificate · redacted copy
IATF 16949:2016
Automotive quality management
Manufacturing of silicone accessories. The certificate scope excludes product design.
- Issued by
- Quality Austria
- Valid from
- Printed expiry
View certificatePartner certificate · redacted copy
IECQ QC080000:2017
Hazardous substance process management
Production and sales of silicone rubber products, excluding activities requiring qualification permits.
- Issued by
- Guangdong Zhonghui Certification
- Valid from
- Printed expiry
View certificatePartner certificate · redacted copy
ISO 14001:2015
Environmental management
Environmental management for silicone rubber production and sales, excluding activities requiring qualification permits.
- Issued by
- Guangdong Zhonghui Certification
- Valid from
- Printed expiry
View certificatePartner certificate · redacted copy
ISO 45001:2018
Occupational health & safety
Occupational health and safety management for silicone rubber production and sales, excluding activities requiring qualification permits.
- Issued by
- Guangdong Zhonghui Certification
- Valid from
- Printed expiry
Manufacturing partner qualifications
Quality standards for your application
These standards relate to our manufacturing partners and the activities within each facility’s certification scope. We review the selected production site and quality documentation against your project requirements.
ISO 13485
Medical silicone programs
Medical silicone rubber production within the certified supplier scope.
Align manufacturing activities with the facility’s certification scope. Plan product approvals, sterility and biocompatibility evaluations separately for the intended application.
IATF 16949
Automotive component production
Applicable silicone accessory and plastic-part manufacturing facilities.
Review the certified manufacturing scope and customer requirements, with product-design responsibilities agreed for each automotive program.
QC080000
Hazardous substance management
Hazardous substance process management for applicable silicone production.
Match material declarations and substance-control records to your part specification. Identify any additional product testing in the inspection plan.
ISO 14001
Environmental management
Environmental management at applicable manufacturing facilities.
Review environmental-management coverage for the selected production site and activities. Define any product-specific environmental requirements in the project specification.
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.
Controlled molding environments
Cleanroom molding for your application
For contamination-sensitive silicone or plastic parts, define the required production area, cleanroom classification and operating conditions during project review.
Cleanroom classification records are reviewed separately from quality-system certificates. We match the environmental documentation and inspection date to your part specification.
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.