EN 12798-2007 en Transport Quality Management System - Road Rail and Inland navigation transport - Quality management system requirements to supplement EN ISO 9001 for the transpor.pdf

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1、BS EN 12798:2007ICS 03.120.10; 13.300NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDTransport qualitysystem Road railand inland navigationtransport Qualitysystem requirementsto supplement EN 9002for the transport ofdangerous goods, withregard to safetyThis Brit

2、ish Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 August2008 BSI 2008ISBN 978 0 580 53850 6Amendments/corrigenda issued since publicationDate CommentsBS EN 12798:2007National forewordThis British Standard is the UK implementation of . It supersedes BSEN

3、12798:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee TW/2, Transport logistics and services.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the neces

4、sary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS EN 12798:2007EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 12798May 2007ICS 03.120.10; 13.300 Supersedes EN 12798:1999 English Versio

5、nTransport Quality Management System - Road, Rail and Inlandnavigation transport - Quality management system requirementsto supplement EN ISO 9001 for the transport of dangerousgoods with regard to safetySystmes qualit Transport - Transport par route, transportferroviaire et transport par voie fluvi

6、ale - Prescriptionsrealtives au systme dassurance qualit pour complterlEN ISO 9001 vis-vis de la scurit pour le transport dematires dangereusesQualittsmanagementsystem fr die Befrderung -Befrderung auf der Strae , mit der Eisenbahn und aufBinnenwasserstraen - Forderungen desQualittsmanagementsystems

7、 zur Ergnzung von EN ISO9001 im Hinblick auf Sicherheit bei der Befrderunggefhrlicher GterThis 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 EuropeanStandard the status o

8、f a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 versi

9、on in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmar

10、k, 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.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEU

11、ROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 12798:2007: EBS EN 12798:2007EN 12798:2007 (E) 2 Contents Page Foreword4 1 Scope 5 2 Normative re

12、ferences 5 3 Terms and 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

13、.3 Quality policy .7 5.4 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 managemen

14、t .8 6.1 Provision of 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

15、.4.1 Process .9 7.4.2 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 Cust

16、omer property.12 7.5.5 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 BS EN 12798:2007EN 12798:2007 (E) 3 8.2.1 Customer satisfaction.12 8.2.2 Internal audit 13 8.2.3 Monitoring

17、and measurement of processes.13 8.2.4 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 BS EN 12798:2007EN 12798:2007 (E)

18、4 Foreword This document (EN 12798:2007) has been prepared 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 endorse

19、ment, at the latest by November 2007, and conflicting 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 implemen

20、t this European Standard: Austria, Belgium, Bulgaria, 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

21、 United Kingdom. BS EN 12798:2007EN 12798:2007 (E) 5 1 Scope This European 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. Applica

22、tion of this document covers, and is limited to, the range of transport 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,

23、 only the edition cited applies. For undated references, the latest edition 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 de

24、finitions apply. 3.1 transport deliberate change of location of dangerous 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 transp

25、ort 3.3 company organisation, or part thereof, involving carrying out 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 Standar

26、d to any transport related service. NOTE 2 The term “supplier“ used in 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 ap

27、ply. Each specific quality management system requirement, unless otherwise indicated in this European Standard, shall apply to both quality and safety. BS EN 12798:2007EN 12798:2007 (E) 6 The quality management system of the company shall address the relevant safety requirements of the regulations f

28、or the transport of dangerous goods. 4.2 Documentation requirements 4.2.1 General EN ISO 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;

29、c) Line of business. Data concerning the transport of dangerous goods: d) Name and address 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

30、chart. The company shall make available proof of insurance coverage or other indemnity 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

31、 EN ISO 9001:2000, 4.2.3 applies. NOTE The documents of external origin mentioned in 4.2.3 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 Co

32、ntrol of records EN ISO 9001:2000, 4.2.4 applies. BS EN 12798:2007EN 12798:2007 (E) 7 5 Management responsibility 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 requireme

33、nt apply. The company shall document its policy for quality and safety and these documents shall be signed 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, au

34、thority and communication 5.5.1 Responsibility and authority EN ISO 9001:2000, 5.5.1 and the following 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

35、the safety obligations incumbent upon them. 5.5.2 Management representative EN ISO 9001:2000, 5.5.2 and 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 b

36、e responsible for both quality and safety aspects of the quality management system or the responsibility 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

37、 internal communication at all levels within the company. The resulting actions taken shall be in writing and subject to an implementation plan. 5.6 Management review EN ISO 9001:2000, 5.6 applies. BS EN 12798:2007EN 12798:2007 (E) 8 6 Resource management 6.1 Provision of resources EN ISO 9001:2000,

38、 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 training 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 regul

39、ations, product knowledge and technology. These requirements shall also cover recruitment and selection of personnel involved 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

40、regarding appropriate medical surveillance of personnel. These requirements shall also apply for temporary personnel. 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

41、 applies. 6.4 Work environment EN ISO 9001:2000, 6.4 applies. 7 Product realization 7.1 Planning of product realization 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. BS EN 12798:2007EN 12798:2007

42、 (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 that subcontractors comply with an equivalent level of safety. This requirement shall be incorporated in the service contract. Adherence to the safety requirements b

43、y subcontractors shall be verified on a regular basis and the results shall be recorded in writing. Exceptionally this requirement may 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 c

44、arried out by specialised undertakings. 7.4.2 Purchasing information EN ISO 9001:2000, 7.4.2 and the following additional requirements apply. Where tank-cleaning services are subcontracted, the purchasing/specification documents shall contain the requirement that cleaning certificates be provided by

45、 the service provider. The service procurer shall retain such certificates with other relevant safety documentation. When the product or service bought corresponds with a requirement of this European Standard, pertinent safety specifications shall be incorporated in the purchasing document. 7.4.3 Ve

46、rification of purchased product EN ISO 9001:2000, 7.4.3 applies. NOTE Receiving inspection and testing procedures should at cover at the 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 Prod

47、uction 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 writt

48、en instructions for the personnel concerned. Where operating activities include an interface with another organization (e.g. loading and unloading locations), the company shall liaise with that organization to ensure that all activities are covered by the agreed operating instructions/procedures and

49、 that particular responsibilities are identified and agreed. 7.5.1.2 Management and use of personal protective equipment Where applicable, the company shall ensure that, at least: personal protective equipment is properly managed, and, especially, that it is kept in prescribed places, known to the personnel; personnel physically involved in the transport of dangerous goods have and use personal protective equipment according to the regulations and special instructions; BS EN 12798:2007EN 12798:2007 (E) 10 personnel are trained in the use of the