Onefive GmbH is certified ISO 9001:2008 and ISO 13485:2012.
The certifications have been accredited by DQS Medizinprodukte GmbH.
The ISO 9001:2008 certification shows that the company is committed to provide cutting edge technology and to produce it with the highest levels of quality in all phases of the product’s life.
The ISO 13485:2012 standard specifies the requirement for a Quality Management System to ensure the production of devices that strictly fulfill the regulatory requirements of medical device production.
The Quality Management System (QMS) is a well established and continuous process at Onefive. From the very beginning it has been a key part of the company’s strategy to deliver high performance products of highest quality to the photonics industry.