[Code of Federal Regulations]

[Title 15, Volume 3]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 15CFR995.25]



[Page 405-406]

 

                  TITLE 15--COMMERCE AND FOREIGN TRADE

 

CHAPTER IX--NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT 

                               OF COMMERCE

 

PART 995_CERTIFICATION REQUIREMENTS FOR DISTRIBUTORS OF NOAA HYDROGRAPHIC 

PRODUCTS--Table of Contents

 

   Subpart C_Requirements for Certified Distributors and Value Added 

                    Distributors of NOAA ENC Products

 

Sec. 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



[[Page 406]]



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]