ISO 13485

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 the ISO 9001, specially developed to allow manufacturers of medical devices to comply with these medical guidelines. The quality management system EN ISO 13485: 2003 is accepted worldwide and sector-wide. The ISO certificate is a standard that sets requirements for the quality management system of an organization.

ISO 13485 and Oceanz 3D printing

Oceanz has set up an official quality policy for obtaining the certificate. During the audit, Oceanz demonstrated a level of quality management that was recognized by the renowned certification and inspection institution LRQA / Lloyds. The ISO certificate is valid for 3 years. Lloyds conducts an audit every year.