 Guidelines & Standards References |
ISO • EN • FDA ISO 13485 Certification |
ISO 13485
ISO (International Organization for Standardization) is a worldwide federation of national standards bodies. The functions of the organization are performed by technical committees which are comprised of representatives from various countries who have an interest in the subject matter of the technical committee. Drafts of any standards proposed by a committee are circulated to all member bodies for voting and must obtain at least a 66% approval in order to pass.
ISO 13485 sets forth quality system requirements for the medical device industry which can be used by a supplier to demonstrate its commitment to quality practices and capabilities. It also defines requirements for the assessment of accomplishment of those practices and capabilities by external parties who audit the supplier.
While certification by, and compliance with, ISO 13485 is voluntary in many countries, those companies who earn certification to this standard demonstrate their firm commitment to quality systems and their recognition of the needs of their own customers who might wish to earn certification. The Quality System models which are called out in ISO 13485 are detailed and highly comprehensive. Complying firms need to have given a great deal of time and personnel attention to quality system development in order to earn certification. All BeamOne contract Service Centers are certified to ISO 13485.
EN 552
In cooperation with EN 46002, which operates as the standards umbrella for sterilization activity, EN 552 sets forth specific guidelines and requirements for proper validation of radiation sterilization methodology.
BeamOne was the first U.S. contract irradiation sterilization services provider to obtain both ISO 9002 (subsequently 13485) and EN 46002 certification. The decision was made to pursue these certifications to demonstrate to BeamOne's customers that we recognize their needs and challenges for the future. BeamOne will continue to do everything in its power to support and assist manufacturers in the development of their own businesses with BeamOne as an integral partner.
Food and Drug AdministrationBeamOne Service Centers are operated under the guidelines of Good Manufacturing Practices.