Izon Science, a leading manufacturer of precision nanotechnology measurement instrumentation, today announced it has achieved ISO 13485:2003 certification.
The quality assurance certification covers the design, development, manufacture and distribution of Izon’s nano- and micro-particle analysis systems.
Hans van der Voorn, Executive Chairman of Izon Science says, “The ISO certification helps address the QA requirements necessary when tackling markets in bioanalysis, diagnostics, pre-clinical testing and vaccine quality assurance.”
The new standard provides a validated structure for product specification, design, production and delivery. Emphasis is placed on identifying customer needs, correctly specifying equipment, and continually checking that those needs are being met. Thorough review, risk assessment and document control systems are built in.
CFR21 Part 11 compliance for Izon Control Suite Software guarantees that electronic records produced by Izon equipment are genuine, tamper-proof, and meet FDA requirements for approval.
The internationally recognized ISO standard will assist Izon Science by providing:
Faster and easier market access
Reduced operational costs by highlighting process deficiencies and improving efficiency
Increased customer satisfaction by consistently delivering quality products and systematically addressing customer feedback
Proven commitment to quality through an internationally recognized standard
"The improved quality management system is a necessary step as we expand our business, and will ensure the robust and scalable processes are in place as we grow and access new markets,” says van der Voorn.
About Izon Science
Izon Science has developed the world’s first nanopore based measurement system available for general use. Izon’s instruments are used for precise measurement and analysis of individual particles across a wide range of scientific fields including bionanotechnology, nanomedicine, vaccinology, microbiology, biomedical research, environmental science, and particle based nanoscience. Izon originated in New Zealand and now sells its products in 34 countries. It has its European headquarters in Oxford, UK and its US headquarters are in Cambridge, MA.