Summary

Quality assurance is vital for the success of radiation technologies and requires the development of standardized procedures and the harmonization of process validation and control. The guidelines in this publication have been developed based on requests from Member States to provide guidance on fulfilling the requirements of the International Standard for Development, Validation and Routine Control for a Radiation Process, published by the International Organization for Standardization (ISO). While the ISO standard was developed for the sterilization of healthcare products, the present guidelines are generalized and are therefore relevant to any radiation process. This is possible since the principles involved in regulating a radiation process for achieving quality products are generally the same for any product or application. In several places, additional information has been included to provide insight into the radiation process that could help irradiator operators and their quality managers to provide better service to their customers.