Certifications
Our certifications confirm our credibility, certify our business processes, and demonstrate our commitment to quality, compliance, and high standards. At SteelcoBelimed, we see certification not as a formality, but as a reflection of our dedication to continuous improvement and responsible innovation. Each certification represents our ongoing effort to ensure safety, reliability, and sustainability across every phase of our operations. By adhering to internationally recognized standards, we strengthen the trust of our partners and customers worldwide, delivering solutions that meet – and often exceed – the industries’ most stringent requirements.
Process Certifications
Our management system complies to the highest international standards: ISO 9001 for Quality Management across our Italian production sites and ISO 13485 for Medical Devices at all healthcare production facilities. Additionally, our Riese Pio X site participates in the MDSAP (Medical Device Single Audit Program) and its quality system is certified MDR.
Product Certifications
SteelcoBelimed medical products are CE-marked Medical Devices, with quality assurance certified by IMQ (0051) or TÜV NORD (0044) per MDR and Directive 93/42/EEC. Our pharmaceutical solutions are developed and manufactured in compliance with cGMP requirements and in accordance with applicable international standards, such as SELO, ASME, and other relevant technical regulations.
The applicable regulations, directives and technical standards for each product are detailed on the corresponding product page
AEO Certifications
Steelco S.p.A., part of the SteelcoBelimed group, is certified as an Authorised Economic Operator (AEO), enabling customers to benefit from significant customs simplifications and streamlined international trade processes.
Environmental Certifications
Our manufacturing sites hold ISO 14001 certification for Environmental Management, while our Italian facilities are also certified to ISO 45001 for Occupational Health and Safety. As part of the Miele Group, we are proud to have achieved the Ecovadis gold rating.
