ISO 9001:2015
In conformity with UNI EN ISO 9001:2015
What it is. The international standard for quality management systems. It certifies that U.Jet works with controlled, documented processes geared towards continuous improvement. What it guarantees for you. Every stage — from design to delivery — follows procedures audited by an independent body, with traceability, supplier control and complaint management: consistent, reliable quality in what you receive.
Scope
Design, production, market placement and ethylene oxide sterilisation of single-use medical devices for the surgical field and patient protection, specialist surgical kits and packs made of non-woven fabric, and single-use ophthalmology devices.
ISO 13485:2016
In conformity with UNI CEI EN ISO 13485:2021 (ISO 13485:2016)
What it is. The quality standard specific to medical devices, recognised worldwide and required by health authorities. What it guarantees for you. The entire life cycle of the single-use device — design, production in a controlled environment, ethylene oxide sterilisation, batch release and post-market surveillance — is managed according to safety and traceability requirements designed for products intended for the operating theatre.
Scope
Quality management system ensuring control of the entire production cycle of single-use medical devices: design, production, ethylene oxide sterilisation and market placement.
ISO 13485:2016
In conformity with UNI CEI EN ISO 13485:2021 (ISO 13485:2016)
What it is. Certifies, to ISO 13485, the specific ethylene oxide (EtO) sterilisation process — the critical stage that makes single-use devices sterile. What it guarantees for you. Process parameters, validation, load control and batch release are managed and audited by an independent body, according to requirements designed for products intended for the operating theatre.
Scope
Ethylene oxide sterilisation of garments, flat and operating drapes, covers, containment systems, kits and specialist disposable sterile and non-sterile surgical packs, in non-woven material and similar devices. Ethylene oxide sterilisation of sterile disposable ophthalmic devices.
ISO 14001:2015
Compliant with ISO 14001:2015
What it is. The international standard for environmental management systems. It certifies that U.Jet monitors and continuously reduces the environmental impact of its activity. What it means for you. You rely on a supplier that manages consumption, waste and emissions under rules audited by an independent body: product quality and environmental responsibility go together.
Scope
Production of polylaminate materials and single-use medical devices in nonwoven fabric, by cutting, assembling and sterilization (IAF 04, 19).
