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1、 Reference number ISO 16106:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 16106 First edition 2006-03-01 Packaging Transport packages for dangerous goods Dangerous goods packagings, intermediate bulk containers (IBCs) and large packagings Guidelines for the application of ISO 9001 Emballage Emballage
2、de transport pour marchandises dangereuses Emballage pour marchandises dangereuses, grands rcipients vrac (GRV) et grands emballages Directives pour lapplication de lISO 9001 ISO 16106:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, th
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5、re that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utiliz
6、ed in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax +
7、41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved ISO 16106:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Quality management system. 2
8、 5 Management responsibility . 2 6 Resource management 2 7 Product realization 2 7.1 Planning of product realization. 2 7.2 Customer-related processes . 2 7.3 Design and development . 2 7.4 Purchasing 2 7.5 Production and service provision. 3 7.6 Control of monitoring and measuring devices 3 8 Measu
9、rement, analysis and improvement . 3 8.1 General. 3 8.2 Monitoring and measurement . 3 8.3 Control of nonconforming product. 4 8.4 Analyses of data . 4 8.5 Improvement . 4 Annex A (normative) Packaging specifications 5 Annex B (normative) IBC specifications 14 Annex C (normative) Items and elements
10、of verification, controls, monitoring and validation 19 Annex D (informative) Typical frequencies for the verification of conformity with design and performance requirements 24 Bibliography. 27 ISO 16106:2006(E) iv ISO 2006 All rights reserved Foreword ISO (the International Organization for Standar
11、dization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to
12、 be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Stan
13、dards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Int
14、ernational Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 16106
15、 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 261, Packaging, in collaboration with Technical Committee ISO/TC 122, Packaging, Subcommittee SC 3, Performance requirements and tests for means of packaging, packages and unit loads (as required by ISO/TC 1
16、22), in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). ISO 16106:2006(E) ISO 2006 All rights reserved v Introduction This International Standard gives guidance for the application of the ISO 9000 quality management system to the manufacture, measuring
17、and monitoring of design type approved dangerous goods packagings, Intermediate Bulk Containers (IBCs) and large packagings. The United Nations Recommendations on the Transport of Dangerous Goods 1 (referred to in this International Standard as the UN Model Regulations) require the application of a
18、quality assurance programme for the manufacture and testing of packagings, IBCs and large packagings that satisfies the competent authority in order to ensure that each manufactured packaging, IBC and large packaging meets the requirements. The UN Model Regulations are given legal entity by the prov
19、ision of a series of international modal agreements and national legislation for the transport of dangerous goods. These international agreements include the European Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR) 2; the Regulations Concerning the International Carr
20、iage of Dangerous Goods by Rail (RID) 3; the International Civil Aviation Organizations Technical Instructions for the Safe Transport of Dangerous Goods by Air 4; the International Maritime Dangerous Goods Code (IMDG) 5. The application of this International Standard will need to take into account t
21、he requirements of these international agreements and the national legislation for the transport of dangerous goods. Compliance with this International Standard does not replace the agreement of competent authorities with quality assurance programmes. In conjunction with ISO 9001, this International
22、 Standard specifies a system for applying quality processes and assurance to the production of dangerous goods packagings, IBCs and large packagings. The change in terminology in the ISO 9000 series from “quality assurance programmes” (1987 edition), over “quality systems” (1994 edition) to “quality
23、 management systems” (2000 edition), is not reflected in the UN Model Regulations and the international agreements referred to in the bibliography of this International Standard. The former term “quality assurance programme” is still used there. Furthermore, the term “testing”, which was used in the
24、 1994 edition of the ISO 9000 series in the context of product inspection and testing has now been replaced by “measurement and monitoring” in the 2000 edition. For the purposes of this International Standard, the latest terminology is used in accordance with ISO 9000. This difference in terminology
25、 should not deter users from using this International Standard. The reasons for establishing this International Standard in addition to the ISO 9000 series are as follows. a) The wording of the requirements in 6.1.1.4, 6.5.1.6.1 and 6.6.1.2 of the UN Model Regulations is restricted to the bare need
26、that a quality assurance programme be applied that satisfies the competent authority. This allows different interpretations. b) Dangerous goods packagings, IBCs and large packagings are subject to legal requirements. The conformity of any manufactured item with the relevant legal provisions is based
27、 on the principle of official design type testing and approval, which requires that specific measures be applied in order to secure the conformity of any of the unlimited number of items with the requirements of an approved design. Quality assurance can help standardize these specific measures. ISO
28、16106:2006(E) vi ISO 2006 All rights reserved c) In view of the cost implications of quality assurance/quality management measures, complete freedom of interpretation could have an avoidable negative impact on competition. d) The establishment of quality assurance/quality management measures is, par
29、ticularly for smaller companies, a large undertaking and calls for further guidance. e) Interactions between companies and competent authorities on the adequacy of quality assurance/quality management programmes need to be rationalized to minimize unnecessary effort. This International Standard is b
30、ased on Revision 14 of the UN Model Regulations. Clause referencing in this International Standard corresponds to ISO 9001:2000, with the exception of the annexes. INTERNATIONAL STANDARD ISO 16106:2006(E) ISO 2006 All rights reserved 1 Packaging Transport packages for dangerous goods Dangerous goods
31、 packagings, intermediate bulk containers (IBCs) and large packagings Guidelines for the application of ISO 9001 1 Scope This International Standard gives guidance on quality management provisions applicable to the manufacture, measuring and monitoring of design type approved dangerous goods packagi
32、ngs, intermediate bulk containers (IBCs) and large packagings. This International Standard can only be used in combination with ISO 9001:2000 and is not a stand-alone document. It does not apply to design type testing, for which reference is made to 6.1.5, 6.5.4 and 6.6.5 of the UN Model Regulations
33、 1. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000, Quality mana
34、gement systems Fundamentals and vocabulary ISO 9001:2000, Quality management systems Requirements ISO/IEC 17050-2, Conformity assessment Suppliers declaration of conformity Part 2: Supporting documentation 3 Terms and definitions For the purposes of this document, the terms and definitions given in
35、ISO 9000 and the following apply. 3.1 competent authority any national regulatory body or authority designated, or otherwise recognized as such, for any purpose in connection with the international agreements referred to in the bibliography of ISO 16106:2006 3.2 design type approved packaging, IBC o
36、r large packaging dangerous goods packaging that has been tested and approved in accordance with chapters 6.1.5, 6.5.4 and 6.6.5 of the UN Model Regulations, the modal agreements listed in the bibliography of ISO 16106:2006 or with national regulations -,-,- ISO 16106:2006(E) 2 ISO 2006 All rights r
37、eserved 4 Quality management system The management system requirements of ISO 9001:2000, Clause 4 apply. Documentation specified in ISO 9001:2000, 4.2.4 should be kept during the assumed lifetime of packagings, IBCs and large packagings or for five years, whichever is longer. 5 Management responsibi
38、lity The management system requirements of ISO 9001:2000, Clause 5 apply. NOTE Documentation can be subject to audit by the competent authority. 6 Resource management The management system requirements of ISO 9001:2000, Clause 6 apply. 7 Product realization 7.1 Planning of product realization The ma
39、nagement system requirements of ISO 9001:2000, 7.1 apply. The product specifications for packaging and IBCs should conform to Annex A and Annex B. NOTE Annex A and Annex B are extracted from ISO 16104:2003, Annex G and ISO 16467:2003, Annex C, respectively. 7.2 Customer-related processes The managem
40、ent system requirements of ISO 9001:2000, 7.2 apply. 7.3 Design and development The management system requirements of ISO 9001:2000, 7.3 apply. For the design validation process, specified in ISO 9001:2000, 7.3.6, reference should be made to the official design validation process (design type testin
41、g and approval procedure) which is completed by the allocation of the UN marking, as required in 6.1.3, 6.5.2 and 6.6.3 of the UN Model Regulations. 7.4 Purchasing The management system requirements of ISO 9001:2000, 7.4 apply. Purchased products should conform to customer requirements and the appro
42、ved design type specification. Verification of conformity by certificates of conformity in accordance with ISO/IEC 17050-2 or any other documentation providing the same level of confidence, or, where those are not provided with the delivery, by tests, should be based on the criteria given in C.1. Th
43、e conformity of components with the approved design type specification should be verified in accordance with the minimum specification data given in Annex A and Annex B. ISO 16106:2006(E) ISO 2006 All rights reserved 3 7.5 Production and service provision 7.5.1 Control of production and service prov
44、ision The management system requirements of ISO 9001:2000, 7.5.1 apply. After any change in process parameters, visual inspection should be carried out to ensure that the changes do not impair or change the specified design type criteria. NOTE Changes in process parameters can change the design char
45、acteristics and require retesting in accordance with 6.1.5, 6.5.4 and 6.6.5 of the UN Model Regulations. 7.5.2 Validation of processes for production and service provision Manufacturing processes should be validated using the control parameters given in C.2. The design type test and approval procedu
46、re is also required as validation of the manufacturing process and the equipment, personnel and procedures involved. 7.5.3 Identification and traceability The management system requirements of ISO 9001:2000, 7.5.3 apply 7.5.4 Customer property The management system requirements of ISO 9001:2000, 7.5
47、.4 apply 7.5.5 Preservation of product The management system requirements of ISO 9001:2000, 7.5.5 apply 7.6 Control of monitoring and measuring devices The management system requirements of ISO 9001:2000, 7.6 apply. 8 Measurement, analysis and improvement 8.1 General The management system requiremen
48、ts of ISO 9001:2000, 8.1 apply. 8.2 Monitoring and measurement The management system requirements ISO 9001:2000, 8.2 apply. Monitoring of production should be based on visual or computer-aided automated monitoring of the manufacturing process to identify any need for adjustment to the function of ma
49、chines and installations. At initial production, first samples should be checked for conformity with the design type specifications as described in Annex A and Annex B. Where applicable, conformity of the following should be verified: dimensions; masses; -,-,- ISO 16106:2006(E) 4 ISO 2006 All rights reserved quality of openings; quality of seams. Monitoring and measurement of the manufactured packagings