Practice guide
Finding the Requirements for a Product
A disciplined route from product identity and intended use to a documented federal requirement register.
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Appendix B establishes quality assurance criteria for applicable nuclear power plant and fuel reprocessing plant activities. Its importance extends through design, procurement, manufacture, installation, testing and operation. A supplier needs to understand the safety function and procurement commitments attached to its work before selecting the controls and records that will demonstrate acceptable performance.
The appendix concerns structures, systems and components that prevent or mitigate the consequences of postulated accidents. Its criteria address activities affecting their safety-related functions. Scope therefore begins with the licensed facility and the item’s function. A commercial catalogue description alone cannot establish whether the nuclear quality assurance requirements apply to a particular purchase.
The criteria address organization, the quality assurance program, design control and procurement document control. They also address instructions, procedures, drawings and document control. Design requirements need to reach the people purchasing material and performing work. A procurement review should establish the controlling technical baseline and the evidence expected from suppliers and their subcontractors.
The appendix includes purchased material and services, identification and control of materials, special processes, inspection, testing and measuring equipment. Handling, storage, shipping and inspection status also receive explicit attention. The organization’s procedures should connect each applicable control to the work actually performed; the presence of a quality manual does not by itself demonstrate implementation.
Nonconforming items, corrective action, quality assurance records and audits are separate criteria. In a supplier review, connect a discrepancy to the affected item, technical disposition and authority for release. Records should allow a later reviewer to reconstruct the accepted configuration and the verification performed, including work completed by a lower-tier supplier.
NCQM practice consideration: establish a requirement matrix at contract review. Assign design verification, source inspection, special-process qualification and record delivery to named organizational roles. Resolve conflicts between the purchase order, drawings and quality requirements before production. A generic statement of compliance is less useful than a traceable account of which requirement governs each activity.
Appendix B is not a universal certification scheme for all industrial goods. The applicable license, regulation and procurement arrangement determine the obligation. Where a purchaser invokes an industry quality standard, identify its edition and contractual status separately. Review the NRC source and the actual procurement documents together when evaluating whether a particular supply package is adequate.
Sources checked 2026-10-19. This is the review date for this profile, separate from any legal effective or compliance date.
Regulatory text
Appendix B — Quality Assurance Criteriawww.ecfr.gov
Agency context
NRC quality assurance regulatory resourceswww.nrc.gov
Practice guide
A disciplined route from product identity and intended use to a documented federal requirement register.
Read the guidePractice guide
A practical examination of identity, method, scope, results and the meaning of a conformity claim.
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