Certifications and approvals demonstrate that processes, responsibilities, quality, and documentation are managed professionally and systematically
ISO 9001:2015 - Link
ISO 9001 is the world's most widely adopted international standard for quality management. It defines the requirements for an effective Quality Management System (QMS), helping organizations streamline processes and production, ensure consistent product quality, and meet regulatory requirements as well as customer expectations.
ISO 13485:2016 - Link
ISO 13485 is an internationally recognized standard for Quality Management Systems (QMS) specifically designed for organizations involved in the design, manufacture, and distribution of medical devices. The standard supports regulatory compliance, risk management throughout the product lifecycle, and imposes stringent requirements for documentation, traceability, and process control.
Clean room (class 8 / 100.000): ISO-norm for class 8 (EN14644 annex B)
A controlled environment compliant with the ISO norm, ensuring that airborne particles, dust, and microorganisms are maintained below strictly defined limits to prevent product contamination.
UN-requirement 3291. Please contact USON PLAST
CE-certificate. Please contact USON PLAST
Operation Clean Sweep - Link
