1、August 2007DEUTSCHE NORM English price group 10No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 03.120.10; 13.300!,z(“9
2、875805www.din.deDDIN EN 12798Transport quality management system Road, rail and inland navigation transport Quality management system requirements to supplement EN ISO 9001for the transport of dangerous goods with regard to safetyEnglish version of DIN EN 12798:2007-08Qualittsmanagementsystem fr die
3、 Befrderung Befrderung auf der Strae, mit der Eisenbahn und auf Binnenwasserstraen Forderungen des Qualittsmanagementsystems zur Ergnzung von EN ISO 9001 imHinblick auf Sicherheit bei der Befrderung gefhrlicher GterEnglische Fassung DIN EN 12798:2007-08SupersedesDIN EN 12798:1999-05www.beuth.deDocum
4、ent comprises 17 pages 10.07DIN EN 12798:2007-08 2 National foreword This standard has been prepared by Working Group WG 3 “Quality of transport of dangerous goods” of CEN/TC 320 “Transport Logistics and services” (Secretariat: DS, Denmark). This standard falls in the domain of the Normenausschuss T
5、ankanlagen (Tank Installations Standards Committee), Technical Committee NA 104-03-02 AA Qualitt des Transports gefhrlicher Gter. The German Technical Committee was however not involved in the preparation of the standard. This revision of the 1999 edition of EN 12798 was necessary due to the withdra
6、wal of the 1994 edition of EN ISO 9002 “Quality systems Model for quality assurance in production, installation and servicing” and the publication of the 2000 edition of EN ISO 9001 “Quality management systems Requirements”. Amendments This standard differs from DIN EN 12798:1999-05 as follows: a) T
7、he reference to EN ISO 9002 has been replaced by reference to EN ISO 9001 throughout the text. Previous editions DIN EN 12798: 1999-05 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12798 May 2007 ICS 03.120.10; 13.300 Supersedes EN 12798:1999 English Version Transport quality management syste
8、m - Road, rail and inland navigation transport - Quality management system requirements to supplement EN ISO 9001 for the transport of dangerous goods with regard to safety Systmes qualit transport - Transport par route, transport ferroviaire et transport par voie fluviale - Prescriptions relatives
9、au systme dassurance qualit pour complter lEN ISO 9001 vis-vis de la scurit pour le transport de matires dangereuses Qualittsmanagementsystem fr die Befrderung - Befrderung auf der Strae , mit der Eisenbahn und auf Binnenwasserstraen - Forderungen des Qualittsmanagementsystems zur Ergnzung von EN IS
10、O 9001 im Hinblick auf Sicherheit bei der Befrderung gefhrlicher Gter This European Standard was approved by CEN on 15 March 2007. 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 stand
11、ard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other
12、language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, F
13、inland, France,Germany, Greece, 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
14、 KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12798:2007: EEN 12798:2007 (E) 2 Contents Page Foreword4 1 Scope 5 2 Normative references 5 3 Terms and
15、 definitions .5 4 Quality management system5 4.1 General requirements5 4.2 Documentation requirements.6 4.2.1 General6 4.2.2 Quality manual .6 4.2.3 Control of documents .6 4.2.4 Control of records6 5 Management responsibility 7 5.1 Management commitment 7 5.2 Customer focus7 5.3 Quality policy .7 5
16、.4 Planning7 5.4.1 Quality objectives 7 5.4.2 Quality management system planning7 5.5 Responsibility, authority and communication7 5.5.1 Responsibility and authority 7 5.5.2 Management representative .7 5.5.3 Internal communication 7 5.6 Management review.7 6 Resource management .8 6.1 Provision of
17、resources8 6.2 Human resources.8 6.2.1 General8 6.2.2 Competence, awareness and training .8 6.3 Infrastructure8 6.4 Work environment .8 7 Product realization.8 7.1 Planning of product realization8 7.2 Customer-related processes 8 7.3 Design and development 8 7.4 Purchasing .9 7.4.1 Process .9 7.4.2
18、Purchasing information 9 7.4.3 Verification of purchased product .9 7.5 Production and service provision9 7.5.1 Control of production and service provision9 7.5.2 Validation of processes for production and service provision 12 7.5.3 Identification and traceability.12 7.5.4 Customer property.12 7.5.5
19、 Preservation of product 12 7.6 Control of monitoring and measuring devices.12 8 Measurement, analysis and improvement 12 8.1 General12 8.2 Monitoring and measurement 12 EN 12798:2007 (E) 3 8.2.1 Customer satisfaction.12 8.2.2 Internal audit 13 8.2.3 Monitoring and measurement of processes.13 8.2.4
20、Monitoring and measurement of product .13 8.3 Control of nonconforming product .13 8.4 Analysis of data .13 8.5 Improvement 13 8.5.1 Continual improvement 13 8.5.2 Corrective action .14 8.5.3 Preventive action.14 Bibliography15 EN 12798:2007 (E) 4 Foreword This document (EN 12798:2007) has been prep
21、ared by Technical Committee CEN/TC 320 “Transport - Logistics and services”, the secretariat of which is held by DS. 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 November 2007, and conflicting
22、national standards shall be withdrawn at the latest by November 2007. This document supersedes EN 12798:1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
23、Cyprus, Czech Republic, Denmark, Estonia, 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 12798:2007 (E) 5 1 Scope This Euro
24、pean Standard specifies quality management system requirements, supplementary to those of EN ISO 9001:2000, for the management of safety in the field of the transport of dangerous goods by road, rail and inland navigation. Application of this document covers, and is limited to, the range of transpor
25、t related services that a company claims to provide in compliance with this European Standard. 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 ed
26、ition of the referenced document (including any amendments) applies. EN ISO 9001:2000, Quality management systems - Requirements (ISO 9001:2000) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 transport deliberate change of location of danger
27、ous goods by road, rail and inland navigation extending from receipt to delivery and including temporary breaks in between 3.2 dangerous goods substances and articles defined and listed in regulations as applicable to their transport 3.3 company organisation, or part thereof, involving carrying out
28、the transport of dangerous goods 3.4 periodic inspection series of planned inspections carried out at specified intervals NOTE 1 The term “product“ used in EN ISO 9001:2000 corresponds with the application of this European Standard to any transport related service. NOTE 2 The term “supplier“ used in
29、 EN ISO 9001:2000 corresponds with the application of this European Standard to any company, as defined above. 4 Quality management system 4.1 General requirements EN ISO 9001:2000, 4.1 and the following additional requirements apply. Each specific quality management system requirement, unless other
30、wise indicated in this European Standard, shall apply to both quality and safety. EN 12798:2007 (E) 6 The quality management system of the company shall address the relevant safety requirements of the regulations for the transport of dangerous goods. 4.2 Documentation requirements 4.2.1 General EN I
31、SO 9001:2000, 4.2.1 and the following additional requirements apply. A company profile shall be available with the following key elements: General data: a) Name and address of head office; b) Legal company status; c) Line of business. Data concerning the transport of dangerous goods: d) Name and add
32、ress of any other depots and offices; e) Number of employees; f) Composition of the fleet; g) Types of dangerous goods generally carried (according to danger classes). The company shall have a clear organizational chart. The company shall make available proof of insurance coverage or other indemnity
33、 arrangements. NOTE Attention is drawn to existing regulations concerning indemnity and relevant to the transport of dangerous goods. 4.2.2 Quality manual EN ISO 9001:2000, 4.2.2 applies. 4.2.3 Control of documents EN ISO 9001:2000, 4.2.3 applies. NOTE The documents of external origin mentioned in 4
34、.2.3 of EN ISO 9001:2000 should include all applicable standards, regulations, codes of practice, service manuals, and general documentation related to safety practices in the transport of dangerous goods. 4.2.4 Control of records EN ISO 9001:2000, 4.2.4 applies. EN 12798:2007 (E) 7 5 Management res
35、ponsibility 5.1 Management commitment EN ISO 9001:2000, 5.1 applies. 5.2 Customer focus EN ISO 9001:2000, 5.2 applies. 5.3 Quality policy EN ISO 9001:2000, 5.3 and the following additional requirement apply. The company shall document its policy for quality and safety and these documents shall be si
36、gned by the manager in charge. 5.4 Planning 5.4.1 Quality objectives EN ISO 9001:2000, 5.4.1 applies. 5.4.2 Quality management system planning EN ISO 9001:2000, 5.4.2 applies. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority EN ISO 9001:2000, 5.5.1 and the following
37、 additional requirement apply. The personnel mentioned in EN ISO 9001:2000, 5.5.1, including temporary personnel, shall be given a functional description of their position in the company and of all the safety obligations incumbent upon them. 5.5.2 Management representative EN ISO 9001:2000, 5.5.2 an
38、d the following additional requirement apply. The responsibility for the safety management system shall be specifically allocated to a named individual. NOTE A single management representative may be responsible for both quality and safety aspects of the quality management system or the responsibili
39、ty for each aspect may be assigned to separate individuals. 5.5.3 Internal communication EN ISO 9001:2000, 5.5.3 and the following additional requirement apply. Safety shall be a continuing topic of internal communication at all levels within the company. The resulting actions taken shall be in writ
40、ing and subject to an implementation plan. 5.6 Management review EN ISO 9001:2000, 5.6 applies. EN 12798:2007 (E) 8 6 Resource management 6.1 Provision of resources EN ISO 9001:2000, 6.1 applies. 6.2 Human resources 6.2.1 General EN ISO 9001:2000, 6.2.1 applies. 6.2.2 Competence, awareness and train
41、ing EN ISO 9001:2000, 6.2.2 and the following additional requirements apply. These requirements shall also cover provisions for refresher training on safety aspects of changing regulations, product knowledge and technology. These requirements shall also cover recruitment and selection of personnel i
42、nvolved in the transport of dangerous goods, based on criteria such as experience, capability, education, proficiency and technical ability. The company shall have in place a policy regarding appropriate medical surveillance of personnel. These requirements shall also apply for temporary personnel.
43、NOTE Regulations may exist with respect to requirements for medical surveillance and the recording and confidentiality of records maintained. 6.3 Infrastructure EN ISO 9001:2000, 6.3 applies. 6.4 Work environment EN ISO 9001:2000, 6.4 applies. 7 Product realization 7.1 Planning of product realizatio
44、n EN ISO 9001:2000, 7.1 applies. 7.2 Customer-related processes EN ISO 9001:2000, 7.2 applies. 7.3 Design and development EN ISO 9001:2000, 7.3 applies. EN 12798:2007 (E) 9 7.4 Purchasing 7.4.1 Process EN ISO 9001:2000, 7.4.1 and the following additional requirements apply. The company shall require
45、 that subcontractors comply with an equivalent level of safety. This requirement shall be incorporated in the service contract. Adherence to the safety requirements by subcontractors shall be verified on a regular basis and the results shall be recorded in writing. Exceptionally this requirement may
46、 be satisfied by a subcontractor submitting only a declaration concerning the safety requirements (see 4.2.4). When tank-cleaning is subcontracted, it shall only be carried out by specialised undertakings. 7.4.2 Purchasing information EN ISO 9001:2000, 7.4.2 and the following additional requirements
47、 apply. Where tank-cleaning services are subcontracted, the purchasing/specification documents shall contain the requirement that cleaning certificates be provided by the service provider. The service procurer shall retain such certificates with other relevant safety documentation. When the product
48、or service bought corresponds with a requirement of this European Standard, pertinent safety specifications shall be incorporated in the purchasing document. 7.4.3 Verification of purchased product EN ISO 9001:2000, 7.4.3 applies. NOTE Receiving inspection and testing procedures should at cover at t
49、he least, containers, means of transport, equipment and maintenance/repair items. These may be new, reconditioned or second-hand, and may be bought or hired. 7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.1.1 General EN ISO 9001:2000, 7.5.1 and the following additional requirements apply. Where the absence of operating instructions/procedures could adversely affect safety, the company shall establish and maintain written instructions for the personnel concerned. Where operating activitie
