The Radiopharmaceuticals Division of the Australian Nuclear Science and Technology Organisation (ANSTO) has been accredited with the international quality standard known as ISO 9001:1994.
Accreditation is good news for patients who need nuclear medicine to diagnose and treat cancer and other diseases. Quality Assurance Manager Jacqueline Whitwell said that the awarding of the internationally recognised standard means that every aspect of production of ANSTO radiopharmaceuticals from design to manufacture is traceable and controllable.
'Patients requiring radiopharmaceuticals and the workers who handle them can be assured that we follow the highest quality standards all the way from order processing, through the production process to patient use,' Ms Whitwell said. "It means that each member of staff involved in the process makes sure that the product complies with specifications before passing it on."
Accreditation means that ANSTO's Radiopharmaceutical Division is endorsed by Australian Standards and listed as a Quality Assurance company in the Australian and international certification network databases. A quality management system that meets the requirements of ISO 9001:1994 focuses on the quality management system's effectiveness in meeting customer requirements and may be used to demonstrate the ability to meet customer requirements, prevent nonconformity and address customer satisfaction and quality improvement.
The certification covers the Quality Management System for research and development and the manufacture of radiopharmaceuticals and radioactive starting materials for use in the manufacture of diagnostic and therapeutic goods for human use, and industrial radioactive sealed sources and associated goods and services.