1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 15358:2011Solid recovered fuels Quality management systems Particular requirements for their application to the production of solid recovered fuels BS EN 15358:2011 BRITISH
2、 STANDARDNational forewordThis British Standard is the UK implementation of EN 15358:2011. Itsupersedes DD CEN/TS 15358:2006 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee PTI/17, Solid biofuels.A list of organizations represented on this committee can
3、 beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 67492 1ICS 75.160.10Compliance with a British Standard cannot confer immunity fromlegal obligations
4、.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2011.Amendments issued since publicationDate Text affectedBS EN 15358:2011EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15358 March 2011 ICS 75.160.10 Supersedes CEN/TS 15358:200
5、6English Version Solid recovered fuels - Quality management systems - Particular requirements for their application to the production of solid recovered fuels Combustibles solides de rcupration - Systmes de management de la qualit - Impositions particulires pour leur application la production de com
6、bustibles solides de rcupration Feste Sekundrbrennstoffe - Qualittsmanagementsysteme - Besondere Anforderungen fr die Anwendung bei der Herstellung von festen Sekundrbrennstoffen This European Standard was approved by CEN on 22 January 2011. CEN members are bound to comply with the CEN/CENELEC Inter
7、nal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any
8、CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official ver
9、sions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, S
10、lovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CE
11、N national Members. Ref. No. EN 15358:2011: EBS EN 15358:2011EN 15358:2011 (E) 2 Contents Page Foreword 4Introduction .51 Scope 72 Normative references 73 Terms and definitions .74 Quality management system 84.1 General requirements 84.1.1 General 94.1.2 Outsourced processes 94.2 Documentation requi
12、rements .94.2.1 General 94.2.2 Quality manual 104.2.3 Control of documents 104.2.4 Control of records. 115 Management responsibility . 115.1 Management commitment . 115.2 Customer focus . 115.3 Quality policy 125.4 Planning . 125.4.1 Quality objectives . 125.4.2 Quality management system planning .
13、135.5 Responsibility, authority and communication . 145.5.1 Responsibility and authority . 145.5.2 Management representative 145.5.3 Internal communication . 155.6 Management review 155.6.1 General . 155.6.2 Review input 165.6.3 Review output . 166 Resource management 166.1 Provision of resources .
14、166.2 Human resources 176.2.1 General . 176.2.2 Competence, awareness and training 176.3 Infrastructure . 186.4 Work environment 187 Product realization 197.1 Planning of product realization . 197.1.1 Product and process validation 197.1.2 Control of changes . 197.2 Customer-related processes . 207.
15、2.1 Determination of requirements related to the product . 207.2.2 Review of requirements related to the product . 207.2.3 Customer communication . 217.3 Design and development . 217.3.1 Design and development planning . 217.3.2 Design and development inputs . 227.3.3 Design and development outputs
16、. 23BS EN 15358:2011EN 15358:2011 (E) 3 7.3.4 Design and development review 247.3.5 Design and development verification 247.3.6 Design and development validation 247.3.7 Control of design and development changes 247.4 Purchasing . 257.4.1 Purchasing process 257.4.2 Purchasing information 267.4.3 Ver
17、ification of purchased product . 267.5 Production and service provision . 287.5.1 Control of production and service provision . 287.5.2 Validation of processes for production and service provision 297.5.3 Identification and traceability . 297.5.4 Customer property 307.5.5 Preservation of product 307
18、.6 Control of monitoring and measuring devices 307.6.1 Measurement system analysis . 317.6.2 Calibration/verification records . 317.6.3 Laboratory/sampling requirements . 318 Measurement, analysis and improvement 328.1 General . 328.2 Monitoring and measurement 338.2.1 Customer satisfaction . 338.2.
19、2 Internal audit 338.2.3 Monitoring and measurement of processes . 348.2.4 Monitoring and measurement of product . 358.3 Control of nonconforming product . 368.3.1 Control of reworked product 368.3.2 Customer information . 368.4 Analysis of data . 368.5 Improvement 378.5.1 Continual improvement 378.
20、5.2 Corrective action . 388.5.3 Preventive action . 39Bibliography 40BS EN 15358:2011EN 15358:2011 (E) 4 Foreword This document (EN 15358:2011) has been prepared by Technical Committee CEN/TC 343 “Solid Recovered Fuels”, the secretariat of which is held by SFS. This European Standard shall be given
21、the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2011, and conflicting national standards shall be withdrawn at the latest by September 2011. This document supersedes CEN/TS 15358:2006. This document differs from CEN/TS 15358
22、:2006 only editorially. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN b
23、y the European Commission and the European Free Trade Association. 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, Croatia, Cyprus, Czech Republic, Denmark, E
24、stonia, 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. BS EN 15358:2011EN 15358:2011 (E) 5 Introduction In the context of soli
25、d recovered fuels (SRF) production, the Quality Management (QM) strategy is mainly based on the fact that, by increasing knowledge about the whole production-process, it is possible to reduce the amount of sampling and testing to be carried out on the final products. This strategy is expressed by go
26、od Quality Management Procedures in the manufacturing process, including good record-keeping. In the context of SRF, Quality Management offers a route through which the confidence of customers and regulators can be established and maintained. The goal of this European Standard is the development of
27、a Quality Management System (QMS) for SRF production and trade that provides for continual improvement, emphasising the fulfilment of quality requirements. This European Standard is a base for developing a QMS for a SRF supplier organization which has not earlier established a QMS. It can also be us
28、ed as a supporting document for a supplier which already has a QMS established. This European Standard, coupled with applicable customer-specific requirements and the normative references specified in Clause 2, defines the fundamental quality management system requirements for those subscribing to t
29、his European Standard. The development of a quality management system for solid recovered fuels based on this European Standard does not involve a compulsory third party certification, however this certification is recommended. The emphasis of this European Standard is on: 1) giving wider confidence
30、 to the production and trading of SRF; 2) defining the documentation to be used for internal procedures and communicating to all parties the specifications needed to ensure the achievement of the quality objectives; 3) verifying the origin and demonstrating the properties of the input materials (i.e
31、. non hazardous wastes). The Quality Management Systems accords with EN ISO 9001 to cover the whole process from the point of waste reception to the point of delivery of SRF to the customer. Quality Management Systems have several important features, including the definition of: a) the key steps in
32、the process; b) the person(s) who is/are responsible for each step of the process, and for the overall co-ordination of quality-management; c) training policies and procedures for execution; d) procedures for production; e) procedures for record-keeping, to provide full traceability; f) procedures f
33、or dealing with failures, and self-improvement; g) procedures for the development of the processing. BS EN 15358:2011EN 15358:2011 (E) 6 To accomplish CEN Internal Regulations for the drafting of documents in this European Standard boxed text is used for the original EN ISO 9001:2008 text, while sec
34、tor-specific supplemental requirements are outside the boxes. In this standard, the word “shall” indicates a requirement while the word “should” indicates a recommendation. Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement. Where the term “such as” i
35、s used, any suggestions given are for guidance only. BS EN 15358:2011EN 15358:2011 (E) 7 1 Scope This European Standard specifies requirements for the quality management system for the production and trade of solid recovered fuels from the reception of waste(s) up to the delivery of solid recovered
36、fuels (Figure 1). Figure 1 Quality management systems within the solid recovered fuels chain 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 edit
37、ion of the referenced document (including any amendments) applies. EN 15357:2011, Solid recovered fuels Terminology, definitions and descriptions EN 15359, Solid recovered fuels Specifications and classes EN ISO 9000:2005, Quality management systems Fundamentals and vocabulary (ISO 9000:2005) EN ISO
38、/IEC 17020, General criteria for the operation of various types of bodies performing inspection (ISO/IEC 17020:1998) EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005) 3 Terms and definitions For the purposes of this document, the t
39、erms and definitions given in EN ISO 9000:2005, EN 15357:2011 and the following apply. 3.1 product realization production of solid recovered fuels BS EN 15358:2011EN 15358:2011 (E) 8 4 Quality management system 4.1 General requirements EN ISO 9001:2008, Quality management systems Requirements 4 Qual
40、ity management system 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall a) determine the processe
41、s needed for the quality management system and their application throughout the organization, b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availabil
42、ity of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure where applicable and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall b
43、e managed by the organization in accordance with the requirements of this International Standard. Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be ap
44、plied to these outsourced processes shall be identified within the quality management system. NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement analysis and improvement. NO
45、TE 2 An “outsourced processes” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. NOTE 3 Ensuring control over outsourced process does not absolve the organization of the responsibility of conformity t
46、o all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as a) the potential impact of the outsourced process on the organizations capability to provide product that conforms to requirements, b) th
47、e to which the control for the process is shared, c) the capability of achieving the necessary control through the application of 7.4. BS EN 15358:2011EN 15358:2011 (E) 9 4.1.1 General The organization shall establish and maintain a programme for achieving its objectives and targets. It shall specif
48、y: a) a designation of responsibilities to named personnel for achieving objectives and targets at each relevant function and level of the organization; b) the means and timeframe by which they are to be achieved. If a project relates to new developments and new or modified activities, or products o
49、r services, programme(s) shall be reviewed and amended as necessary to ensure that quality management is applied appropriately to such projects. The organization shall establish and maintain internal procedures for defining responsibility and authority for handling and investigating non-conformity, taking action to mitigate any impacts caused and to initiate and complete corrective and preven
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