Mostly every organization globally producing products of industrial applications is overseen by some form a management or quality program. These programs exist to help manage business effectively and put in place best practice methodologies. Elements within these practices focus on outcomes which led to time and cost saving measures, increased efficiencies, and improved customer relationships. These program are successful due to continuous improvements, gaining greater control over processes, and therefore greater control over the results. These programs provide an organization a business culture which validates inherent quality of any product produced using best practice methodologies. Although some programs are meant to have universal application cross cutting multiple industries, there are specific industrial applications in which even the most widely used programs fall short.
ISO 9001 has been implemented by more than one million organizations in more than 75 countries. Many organizations interested in pursuing business in the nuclear industry, find that their ISO 9001 program must be modified to meet the requirements of Nuclear Quality Assurance. In its basic form, a Quality Management Program such as ISO 9001 is a business-process program. ISO standards are considered generic management standards that are universally applicable and do not differentiate between large and small companies.
For the required level of emphasis on safety and regulatory oversight, the aerospace industry is most aligned to the nuclear industry. The aerospace industry Quality Management System (QMS), AS9100, was first implemented in 1997, following cancellation of quality system specifications by the Department of Defense. Due to the lack of a government endorsed quality system by the Federal Aviation Administration, the aerospace industry independently developed a sector-specific quality program so that it could pass uniform requirements to its suppliers. The 2000 edition of AS9100, developed to conform to the 2000 edition of ISO 9001, added 80 additional requirements and amplified the original 18 requirements. Areas that the aerospace industry believed were not adequately addressed by ISO 9001 include design, development, manufacture, assembly, reliability, maintainability, servicing of aerospace products, and regulatory compliance.
In the nuclear industry similar evaluations have come to same conclusion. Evaluations for nuclear applicability done by the US NRC (SECY-03-0117), ASME (STP-NU-062), and the IAEA (Safety Report No. 22) have shown that an ISO 9001 program alone does not guarantee compliance or quality of end products and services. Most show that requirements in areas such as the quality assurance program, training and qualification, design and independence of design verification, and independence of inspection and testing activities did not meet applicable requirements for the nuclear industry. Other areas such as, documentation, nonconformance control, corrective actions, document control and records, inspection and testing, and audits also had to be heavily modified.
Although some standards such as the RCC-M, JSME, and CSA recognizes ISO in their code and regulatory frame work, there are usually several supplementary requirements added for procurement of components. These requirements include additional provisions for design verification, document and data control, purchasing data, product identification and traceability, inspection and testing, and control of nonconforming products. In some cases ISO is allowed only for procurement of components outside the primary system pressure boundary.
Although ISO has improved many organizations best practices, proven successful, and is widely used, a nuclear organization using ISO alone would not achieve the required level assurance required by nuclear industry. Most nuclear standards reflect industry experience and current understanding of the quality assurance requirements necessary to achieve safe, reliable, and efficient utilization of nuclear energy, and management and processing of radioactive materials. This standard focuses on the achievement of results, emphasizes the role of the individual and line management in the achievement of quality, and foster the application of these requirements in a manner consistent with the relative importance of the item or activity. The emphasis on the component versus a process orientated approach assures the safe operation of any nuclear power plant.