Quality & standards
Quality is built into how we plan, make, paint and inspect every part, from incoming raw material to the final painted product. Our management systems are certified to ISO 13485, ISO 9001, ISO 14001 and ISO 45001, and our PU-RIM parts are UL Recognized.
Certifications
Our quality, environmental and safety systems are audited by accredited third parties, so you can qualify us with confidence.
Medical device quality system for our molded and machined instrument parts.
View certificate for ISO 13485:2016 (PDF, opens in a new tab)Quality management across our machining, molding and blow molding production.
View certificate for ISO 9001:2015 (PDF, opens in a new tab)Managing and reducing the environmental impact of our operations.
View certificate for ISO 14001:2015 (PDF, opens in a new tab)An audited system for keeping our people safe and healthy at work.
View certificate for ISO 45001:2018 (PDF, opens in a new tab)Our polyurethane (PU-RIM) parts are UL Recognized for use in certified equipment.
Request a copy of the UL QMMY2 certificateCertificates open as PDF in a new tab. For a copy of any other quality document, contact our team.
ISO 13485 is the international quality management standard for organisations involved in medical devices. Our certification sets the rules for how we control documents, processes, inspection and traceability for medical and diagnostic instrument components.
QMMY2 is UL’s Fabricated Parts – Component category, which covers material traceability for molded and fabricated plastic parts used in UL-certified equipment. We have held it for our polyurethane reaction injection molding (PU-RIM) production since 2016. Our PU-RIM parts are molded in a UL 94 V-0 flame-rated polyurethane (Covestro Baydur 110 FR-2N).
In-house quality control
Our own quality team checks geometry, appearance and finish at every stage, so a part is only approved when it fits and looks right.
Raw materials and purchased components are verified against specification before release to production.
First-article and in-process checks during molding, machining and painting keep every process stable.
Parts are measured against your drawings and CAD, from small precision features to large panels.
Visible surfaces are inspected for defects to agreed cosmetic standards before parts move on.
Every finish is checked for colour match, gloss level, coating thickness and adhesion.
Large panels are checked for profile, fit and flatness on purpose-built fixtures that replicate how they mount on the final product.
A final inspection confirms each shipment meets drawing, finish and packaging requirements.
Inspection records and material traceability are maintained under our ISO 13485 system.
Dimensional quality
Dimensional inspection runs alongside production, from first articles through repeat orders, with results recorded for traceability. When a part needs to mate with others in your assembly, we check that too.
Large-part inspection
Large instrument dress panels and covers are checked on dedicated fixtures that replicate how they mount on the final product. This verifies profile and fit before parts leave the factory, not on your assembly line.
Ask us about inspection plans, first-article reports and our certifications as part of your RFQ.