Quality assurance standards: comparison between IAEA 50-C/SG-Q and ISO 9001:1994

The International Atomic Energy Agency (IAEA) and the International Organization for Standardization (ISO) agreement regarding the scope and coverage of documents published by both organizations points out that the standards of safety developed by the IAEA are recommendations for use by its Member States in the framework of national regulations for the safe utilization of nuclear energy. Such standards should be considered as nuclear safety regulatory documents. The standards developed by the ISO are complementary technical documents emphasizing industrial application and contractual aspects. Regarding the quality assurance topic, the IAEA standards 50-C/SG-Q are mostly used directly or indirectly to establish the nuclear safety requirements at the utility-regulatory interface. The industrial ISO 9001 standards have progressively been used to implement the quality assurance requirements at the interface utility-supplier. The relationship between both standards is growing in significance owing to the impact upon the owners/operators of nuclear facilities and their contractors/suppliers. The relationship between the IAEA and ISO standards is considered critical, in particular regarding suppliers with a small range of nuclear supplies. These organizations are not always willing to prepare special quality assurance programmes based on nuclear safety standards. On the other hand, these organizations may be qualified on the basis of the ISO quality assurance standards. In any case, for delivering nuclear items and services the quality assurance programme must comply with the requirements established in the nuclear safety regulatory standards. This implies that the utility-supplier will have to demonstrate that the acceptable degree of quality assurance in relation to nuclear safety is accomplished. This may be achieved by imposing additional requirements on the supplier over and above those contained within the ISO. In order to provide a description of the differences between the IAEA and ISO standards when applied in nuclear installations, and to support the practical way of fulfilling nuclear safety, the IAEA established a project for producing a guidance report. Valuable contributions from the European Atomic Forum (FORATOM) were committed and contractual arrangements made, with the target of finalizing the report in the shortest feasible timeframe commensurable with available resources. The International Atomic Energy Agency (IAEA) Code and Safety Guides contained in the Safety Series No. 50-C/SG-Q define basic quality assurance requirements, which must be considered to ensure safety, and provides recommendations on how to fulfill these basic requirements. The IAEA 50-C/SG-Q standard reflects the performance based approach to quality assurance covering all aspects of plant safety, economics and efficiency. The IAEA requirements and recommendations are generally used at the nuclear utility-regulator interface. The International Organization for Standardization (ISO) International Standard ISO 9001:1994 specifies quality system requirements for use where any supplier's capability to design and supply a conforming product needs to be demonstrated. The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing. The ISO 9001:1994 standard is sometimes used at the nuclear utility-supplier interface. The objective of this report is to compare the requirements of IAEA 50-C/SG-Q (1996) with ISO 9001:1994 in order to identify the main differences and additional requirements contained within. The report also provides information and guidance, which may be considered when ISO 9001:1994 is utilized by the nuclear industry