What does ISO 13485 stand for?
European legislation imposes strict requirements on the production of medical devices. The ISO 13485 certificate is the medical version of ISO 9001, specially developed to allow manufacturers of medical devices to comply with these medical directives. The quality management system EN ISO 13485:2016 is accepted worldwide and branch-wide. The ISO certificate is a standard that imposes requirements on an organisation’s quality management system.
ISO 13485 and Oceanz 3D printing: since 2015
Oceanz has drawn up an official quality policy for the purpose of obtaining the certificate. During the audit, Oceanz demonstrated a level of quality management that was recognised by the renowned certification and inspection body LRQA/Lloyds. The ISO certificate is valid for 3 years. Lloyds carries out an annual audit.