Iso 13485 Medical Industry Certification

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design development production installation and delivery of medical. ISO 13485:2003 certification is a medical industry international standard that sets specific quality requirements for manufacturers of medical devices. Devices are required to conform to the requirements of ISO 13485 Medical Devices in order to be entitled to show the CE marking. The Oxford Quality Centre has a range of consultants across the country
This follow up audit process is conducted annually as required for certification to ensure ongoing compliance with the certified standard requirements.
ISO 13485 and 9001 certification is a natural next step. Following extensive research and planning we undertook to become certified in the worldwide-recognized ISO standards as the basis for our design processes
ISO 13485 is an internationally recognized standard of quality which articulates the stringent requirements of the Quality Management System (QMS) for the design and manufacture of medical devices. The ISO 13485 Standard specifies the requirements for a Quality Management System which a manufacturers or distributers of medical devices needs to demonstrate. This Quality Standard also proves the organizational commitment and ability of the Company to provide design manufacture and sale of medical device.