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IATA危险品规章 Dangerous Goods Regulations 2(61)

时间:2014-11-10 01:35来源:IATA 作者:航空 点击:
  
6.4.2.5.2.4 The inspection body must be approved by (c) the relevant cylinder and closed cryogenic receptacle the appropriate national authority for the inspection of manufacturing, quality control, quality assurance, and cylinders and closed cryogenic receptacles and must: process operation instructions that will be used;
(a)
have a staff with an organisational structure, capable,  (d) quality records, such as inspection reports, test data
trained, competent, and skilled, to satisfactorily per-and calibration data;
form its technical functions; (e) management reviews to ensure the effective oper-
(b)have access to suitable and adequate facilities and ation of the quality system arising from the audits in equipment; accordance with 6.4.2.5.3.2;
(c)operate in an impartial manner and be free from any (f) the process describing how customer requirements influence which could prevent it from doing so; are met;
(d)
ensure commercial confidentiality of the commercial  (g) the process for control of documents and their
and proprietary activities of the manufacturer and revision;
other bodies; (h) the means for control of non-conforming cylinders
(e)maintain clear demarcation between actual inspec-and closed cryogenic receptacles, purchased compo-tion body functions and unrelated functions; nents, in-process and final materials; and
(f)
operate a documented quality system;  (i) training programmes and qualification procedures for
(g)
ensure that the tests and inspections specified in the  relevant personnel.
relevant cylinder and closed cryogenic receptacle 6.4.2.5.3.2 Audit of the Quality System. The manufac-standard and these Regulations are performed; and
turer's quality system must be audited as follows:
(h)  maintain an effective and appropriate report and (a) the quality system must be initially assessed to record system in accordance with 6.4.2.5.6.
determine whether it meets the requirements in
6.4.2.5.2.5 The inspection body must perform design 6.4.2.5.3.1 to the satisfaction of the appropriate type approval, and cylinder and closed cryogenic recep-national authority; 6.4 tacle production testing, inspection and certification to (b) the manufacturer must be notified of the results of verify conformity with the relevant cylinder and closed the audit. The notification must contain the con-cryogenic receptacle standard (see 6.4.2.5.4 and clusions of the audit and any corrective actions 6.4.2.5.5). required;
6.4.2.5.2.6  The Manufacturer must: (c) periodic audits must be carried out, to the satisfaction of the appropriate national authority, to ensure that
(a) operate a documented quality system in accordance the manufacturer maintains and applies the quality with 6.4.2.5.3;
system. Reports of the periodic audits must be
(b)apply for design type approvals in accordance with provided to the manufacturer. 6.4.2.5.4;
6.4.2.5.3.3 Maintenance of the Quality System. The
(c)
select an inspection body from the list of approved
manufacturer must: inspection bodies maintained by the appropriate
national authority in the country of approval; and (a)  maintain the quality system as approved in order that it remains adequate and efficient;
(d) maintain records in accordance with 6.4.2.5.6.
(b) notify the appropriate national authority that approved
6.4.2.5.2.7 The Testing Laboratory must have:  the quality system, of any intended changes. The
(a)staff with an organizational structure, sufficient in proposed changes must be evaluated in order to number, competence and skill; and determine whether the amended quality system will
(b)
suitable and adequate facilities and equipment to still satisfy the requirements in 6.4.2.5.3.1. perform, to the satisfaction of the inspection body, the tests required by the manufacturing standard. 6.4.2.5.4 Approval Process
6.4.2.5.4.1 Initial Design Type Approval. The initial
6.4.2.5.3 Manufacturer's Quality System  design type approval must consist of the approval of the
6.4.2.5.3.1  Quality System Requirements. The quality manufacturer's quality system and the approval of the cylinder and closed cryogenic receptacle design to
system must contain all the elements, requirements and be produced. An application for an initial design type
provisions adopted by the manufacturer. It must be documented in a systematic and orderly manner in the approval must meet the requirements of 6.4.2.5.4.2 to
6.4.2.5.4.6 and 6.4.2.5.4.9.
form of written policies, procedures and instructions. The contents must in particular include adequate 6.4.2.5.4.2 A manufacturer desiring to produce cylinders descriptions of: and closed cryogenic receptacles in accordance with a
(a)the organizational structure and responsibilities of cylinder and closed cryogenic receptacle standard and personnel with regard to design and product quality; these Regulations must apply for, obtain and retain a
(b)
the design control and design verification techniques,  Design Type Approval Certificate issued by the appropri-
processes and procedures that will be used when  ate national authority in the country of approval for at least one cylinder and closed cryogenic receptacle
designing the cylinders and closed cryogenic recep-design type in accordance with the procedure given
tacles; in 6.4.2.5.4.9. This certificate must, on request, be
submitted to the appropriate national authority of the country of use.
6.4.2.5.4.3 An application must be made for each manu-facturing facility and must include:
(a)the name and registered address of the manufacturer and, in addition, if the application is submitted by an authorized representative, its name and address;
(b)the address of the manufacturing facility (if different from the above);
(c)the name and title of the person(s) responsible for the quality system;
 
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