10 CFR 50 Appendix B Criterion I, Organization

v t e 10 CFR 50 Appendix B
Organization
Criterion 1	The applicant shall be responsible for the establishment and execution of the quality assurance program. The applicant may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part thereof, but shall retain responsibility for the quality assurance program. The authority and duties of persons and organizations performing activities affecting the safety-related functions of structures, systems, and components shall be clearly established and delineated in writing. These activities include both the performing functions of attaining quality objectives and the quality assurance functions. The quality assurance functions are those of (1) assuring that an appropriate quality assurance program is established and effectively executed; and (2) verifying, such as by checking, auditing, and inspecting, that activities affecting the safety-related functions have been correctly performed. The persons and organizations performing quality assurance functions shall have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions. There persons and organizations performing quality assurance functions shall report to a management level so that the required authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations, are provided. Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location or locations where activities are performed, the organizational structure for executing the quality assurance program may take various forms, provided that the persons and organizations assigned the quality assurance functions have the required authority and organizational freedom. Irrespective of the organizational structure, the individual(s) assigned the responsibility for assuring effective execution of any portion of the quality assurance program at any location where activities subject to this appendix are being performed, shall have direct access to the levels of management necessary to perform this function.
10 CFR 50 Appendix B Criterion I, Organization 10 CFR 50 Appendix B Criterion II, Quality Assurance Program 10 CFR 50 Appendix B Criterion III, Design Control 10 CFR 50 Appendix B Criterion IV, Procurement Document Control 10 CFR 50 Appendix B Criterion V, Instructions, Procedures, and Drawings 10 CFR 50 Appendix B Criterion VI, Document Control 10 CFR 50 Appendix B Criterion VII, Control of Purchased Material, Equipment, and Services 10 CFR 50 Appendix B Criterion VIII, Identification and Control of Materials, Parts, and Components 10 CFR 50 Appendix B Criterion IX, Control of Special Processes 10 CFR 50 Appendix B Criterion X, Inspection 10 CFR 50 Appendix B Criterion XI, Test Control 10 CFR 50 Appendix B Criterion XII, Control of Measuring and Test Equipment 10 CFR 50 Appendix B Criterion XIII, Handling, Storage and Shipping 10 CFR 50 Appendix B Criterion XIV, Inspection, Test, and Operating Status 10 CFR 50 Appendix B Criterion XV, Nonconforming Materials, Parts, or Components 10 CFR 50 Appendix B Criterion XVI, Corrective Action 10 CFR 50 Appendix B Criterion XVII, Control of Purchased Material, Equipment, and Services 10 CFR 50 Appendix B Criterion XVIII, Audits

10 CFR 50 Appendix B Criterion I, Organization

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