1、 DEUTSCHE NORMJune 2006DIN EN ISO 16106 ICS 13.300; 55.180.99 Packaging Transport packages for dangerous goods Dangerous goods packagings, intermediate bulk containers (IBCs) and large packagings Guidelines for the application of ISO 9001 (ISO 16106:2006) English version of DIN EN ISO 16106:2006-06
2、Verpackung Verpackungen zur Befrderung gefhrlicher Gter Gefahrgutverpackungen, Gropackmittel (IBC) und Groverpackungen Leitfaden fr die Anwendung der ISO 9001 (ISO 16106:2006) Englische Fassung DIN EN ISO 16106:2006-06 Document comprises 34 pages No part of this standard may be reproduced without pr
3、ior permission of DIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany, has the exclusive right of sale for German Standards (DIN-Normen). English price group 15 www.din.de www.beuth.de !,o4r“11.06 9761779DIN EN ISO 16106:2006-06 2 National foreword This standard
4、 has been published in accordance with a decision taken by CEN/TC 261 to adopt, without al-teration, International Standard ISO 16106 as a European Standard. The responsible German body involved in its preparation was the Normenausschuss Verpackungswesen (Packaging Standards Committee), Technical Co
5、mmittee NA 115-01-06 AA Gefahrgutverpackungen. The DIN Standards corresponding to the International Standards referred to in clause 2 of the EN are as fol-lows: ISO 9000 DIN EN ISO 9000 ISO 9001 DIN EN ISO 9001 ISO/IEC 17050-2 DIN EN ISO/IEC 17050-2 National Annex NA (informative) Bibliography DIN E
6、N ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO/IEC 17050-2, Conformity assessment Suppliers declaration of conformity Part 2: Support-ing documentation EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 161
7、06 March 2006 ICS 55.020; 13.300 English Version Packaging - Transport packages for dangerous goods - Dangerous goods packagings, intermediate bulk containers (IBCs) and large packagings - Guidelines for the application of ISO 9001 (ISO 16106:2006) Emballage - Emballage de transport pour marchandise
8、s dangereuses - Emballage pour marchandises dangereuses, grands rcipients vrac (GRV) et grands emballages - Directives pour lapplication de lISO 9001 (ISO 16106:2006) Verpackung - Verpackungen zur Befrderung gefhrlicher Gter - Gefahrgutverpackungen, Gropackmittel (IBC) und Groverpackungen - Richtlin
9、ien fr die Anwendung der ISO 9001 (ISO 16106:2006) This European Standard was approved by CEN on 3 February 2006. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any a
10、lteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by tr
11、anslation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece
12、, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management
13、 Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16106:2006: EEN ISO 16106:2006 (E) 2 Foreword This document (EN ISO 16106:2006) has been prepared by Technical Committee CEN/TC 2
14、61 “Packaging”, the secretariat of which is held by AFNOR, in collaboration with Technical Committee ISO/TC 122 “Packaging”. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2006, and con
15、flicting national standards shall be withdrawn at the latest by September 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia
16、, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN ISO 16106:2006 (E) 3 Contents Page Foreword .2 Introduction.4 1 Scope6 2 N
17、ormative references6 3 Terms and definitions .6 4 Quality management system7 5 Management responsibility 7 6 Resource management.7 7 Product realization 7 7.1 Planning of product realization7 7.2 Customer-related processes7 7.3 Design and development7 7.4 Purchasing .7 7.5 Production and service pro
18、vision .8 7.6 Control of monitoring and measuring devices 8 8 Measurement, analysis and improvement8 8.1 General .8 8.2 Monitoring and measurement 8 8.3 Control of nonconforming product .9 8.4 Analyses of data 9 8.5 Improvement 9 Annex A (normative) Packaging specifications.10 Annex B (normative) IB
19、C specifications 19 Annex C (normative) Items and elements of verification, controls, monitoring and validation.24 Annex D (informative) Typical frequencies for the verification of conformity with design and performance requirements.29 Bibliography32 EN ISO 16106:2006 (E) 4 Introduction This Interna
20、tional Standard gives guidance for the application of the ISO 9000 quality management system to the manufacture, measuring and monitoring of design type approved dangerous goods packagings, Intermediate Bulk Containers (IBCs) and large packagings. The United Nations Recommendations on the Transport
21、of Dangerous Goods 1(referred to in this International Standard as the UN Model Regulations) require the application of a 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 manufactu
22、red packaging, IBC and large packaging meets the requirements. The UN Model Regulations are given legal entity by the provision of a series of international modal agreements and national legislation for the transport of dangerous goods. These international agreements include the European Agreement C
23、oncerning the International Carriage of Dangerous Goods by Road (ADR) 2; the Regulations Concerning the International Carriage 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 Internation
24、al Maritime Dangerous Goods Code (IMDG) 5. The application of this International Standard will need to take into account the requirements of these international agreements and the national legislation for the transport of dangerous goods. Compliance with this International Standard does not replace
25、the agreement of competent authorities with quality assurance programmes. In conjunction with ISO 9001, this International 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
26、 the ISO 9000 series from “quality assurance programmes” (1987 edition), over “quality systems” (1994 edition) to “quality 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.
27、 The former term “quality assurance programme” is still used there. Furthermore, the term “testing”, which was used in the 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
28、of this International Standard, the latest terminology is used in accordance with ISO 9000. This difference in terminology 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
29、 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 that a quality assurance programme be applied that satisfies the competent authority. This allows different interpretations. b) Dangerous goods packagings, IBCs and large packagi
30、ngs are subject to legal requirements. The conformity of any manufactured item with the relevant legal provisions is based 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
31、of items with the requirements of an approved design. Quality assurance can help standardize these specific measures. EN ISO 16106:2006 (E) 5 c) In view of the cost implications of quality assurance/quality management measures, complete freedom of interpretation could have an avoidable negative impa
32、ct on competition. d) The establishment of quality assurance/quality management measures is, particularly 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 pro
33、grammes need to be rationalized to minimize unnecessary effort. This International Standard is based 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. EN ISO 16106:2006 (E) 6 1 Scope This Int
34、ernational Standard gives guidance on quality management provisions applicable to the manufacture, measuring and monitoring of design type approved dangerous goods packagings, intermediate bulk containers (IBCs) and large packagings. This International Standard can only be used in combination with I
35、SO 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 1. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated r
36、eferences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000, Quality management systems Fundamentals and vocabulary ISO 9001:2000, Quality management systems Requirements ISO/IEC 17050-2, Conformity ass
37、essment Suppliers declaration of conformity Part 2: Supporting documentation 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply. 3.1 competent authority any national regulatory body or authority designated, or otherwise reco
38、gnized 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 or 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
39、of the UN Model Regulations, the modal agreements listed in the bibliography of ISO 16106:2006 or with national regulations EN ISO 16106:2006 (E) 7 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
40、be kept during the assumed lifetime of packagings, IBCs and large packagings or for five years, whichever is longer. 5 Management responsibility The management system requirements of ISO 9001:2000, Clause 5 apply. NOTE Documentation can be subject to audit by the competent authority. 6 Resource mana
41、gement The management system requirements of ISO 9001:2000, Clause 6 apply. 7 Product realization 7.1 Planning of product realization The management 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
42、and Annex B are extracted from ISO 16104:2003, Annex G and ISO 16467:2003, Annex C, respectively. 7.2 Customer-related processes The management 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 v
43、alidation process, specified in ISO 9001:2000, 7.3.6, reference should be made to the official design validation process (design type testing 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 Purchas
44、ing The management system requirements of ISO 9001:2000, 7.4 apply. Purchased products should conform to customer requirements and the approved design type specification. Verification of conformity by certificates of conformity in accordance with ISO/IEC 17050-2 or any other documentation providing
45、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. The conformity of components with the approved design type specification should be verified in accordance with the minimum specification data given in Annex A and
46、 Annex B. EN ISO 16106:2006 (E) 8 7.5 Production and service provision 7.5.1 Control of production and service provision 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
47、 impair or change the specified design type criteria. NOTE Changes in process parameters can change the design characteristics 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
48、 processes should be validated using the control parameters given in C.2. The design type test and approval procedure 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 requirem
49、ents of ISO 9001:2000, 7.5.3 apply 7.5.4 Customer property The management system requirements of ISO 9001:2000, 7.5.4 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 requirements of ISO 9001:2000, 8.1 apply. 8.2 Monitoring and measurement The management system requirements ISO 9001:
