Title 15
SECTION 995.25
995.25 Quality management system.
§ 995.25 Quality management system.(a) Quality management system for CEVADs. (1) CEVAD shall operate a quality management system, based on ISO 9001-2000 or equivalent, which embraces all elements of the process used to process and redistribute NOAA ENC files. The minimum requirements for such a quality management system are those defined in this part. The quality management system must ensure that the production process complies with all relevant requirements of this part.
(2) The quality management system must, at a minimum, include an adequate account of:
(i) The quality objectives and the organizational structure, responsibilities, and powers of management with regard to production quality;
(ii) The techniques, processes, and systematic actions that will be used for quality management throughout the production process, including NOAA ENC conversion and the quality of the product being redistributed;
(iii) The examination and tests that will be carried out before, during, and after processes essential for the quality of the product, and the frequency with which they will be carried out;
(iv) The quality records, such as inspection records and test data, qualification reports of personnel concerned resulting from the program specified herein; and
(v) The means for monitoring the achievement of the required quality of the product and the effective operation of the quality management system.
(3) Design and development changes shall be reviewed, verified, and validated as appropriate and approved by the ISO 9001 certification authority (or equivalent if another quality management system is used) before implementation.
(4) If the type approved conversion software is maintained by a third party, CEVAD shall ensure that no changes made to the conversion software render the type approval of the conversion software invalid, and shall evaluate the effects of such changes on the end users of the product.
(5) CEVAD shall analyze both internal information and that received from external parties in order to continually monitor and improve the production process and the product being redistributed.
(6) CEVAD shall ensure that personnel performing work affecting the production process are competent with regard to appropriate education, training, skills, and expertise.
(7) CEVAD shall conduct internal audits at planned intervals to determine whether the quality management system conforms to the requirements of this part and is effectively implemented and maintained. The audit program shall take into consideration the individual processes' importance in relation to the product quality, as well as results of previous audits. Selection of auditors and conducting of audits shall, as far as practicable, insure objectivity and impartiality in the audit process.
(8) CEVAD shall ensure that actions are taken without undue delay to eliminate detected non-conformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results.
(b) [Reserved]