Solid recovered fuels - Quality management systems - Particular requirements for their application to the production of solid recovered fuels

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 fuels (Figure 1).

Feste Sekundärbrennstoffe - Qualitätsmanagementsysteme - Besondere Anforderungen für die Anwendung bei der Herstellung von festen Sekundärbrennstoffen

Diese Europäische Norm legt die Anforderungen an das Qualitätsmanagementsystem für die Herstellung von
und den Handel mit festen Sekundärbrennstoffen fest, beginnend mit der Annahme des Abfalls (der Abfälle)
bis hin zur Lieferung von festen Sekundärbrennstoffen (siehe Bild 1).

Combustibles solides de récupération - Systèmes de management de la qualité - Impositions particulières pour leur application à la production de combustibles solides de récupération

La présente Norme européenne établit les prescriptions applicables à un système de management de la qualité pour la production et le commerce de combustibles solides de récupération de la réception des déchets à la livraison des combustibles solides de récupération (Figure 1).

Trdna alternativna goriva - Sistemi vodenja kakovosti - Posebne zahteve za njihovo uporabo pri proizvodnji trdnih alternativnih goriv

Ta evropski standard določa zahteve za sistem vodenja kakovosti za proizvodnjo in promet s trdnimi alternativnimi gorivi od sprejema odpadkov do dostave trdnih alternativnih goriv (slika 1).

General Information

Status
Published
Public Enquiry End Date
30-Aug-2009
Publication Date
07-Apr-2011
Technical Committee
Current Stage
6100 - Translation of adopted SIST standards (Adopted Project)
Start Date
27-May-2013
Due Date
26-May-2014
Completion Date
08-Jan-2014

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Trdna alternativna goriva - Sistemi vodenja kakovosti - Posebne zahteve za njihovo uporabo pri proizvodnji trdnih alternativnih gorivFeste Sekundärbrennstoffe - Qualitätsmanagementsysteme - Besondere Anforderungen für die Anwendung bei der Herstellung von festen SekundärbrennstoffenCombustibles solides de récupération - Systèmes de management de la qualité - Impositions particulières pour leur application à la production de combustibles solides de récupérationSolid recovered fuels - Quality management systems - Particular requirements for their application to the production of solid recovered fuels75.160.10Trda gorivaSolid fuels03.120.99Drugi standardi v zvezi s kakovostjoOther standards related to qualityICS:Ta slovenski standard je istoveten z:EN 15358:2011SIST EN 15358:2011en,fr,de01-maj-2011SIST EN 15358:2011SLOVENSKI

STANDARDSIST-TS CEN/TS 15358:20071DGRPHãþD
SIST EN 15358:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15358
March 2011 ICS 75.160.10 Supersedes CEN/TS 15358:2006English Version

Solid recovered fuels - Quality management systems - Particular requirements for their application to the production of solid recovered fuels

Combustibles solides de récupération - Systèmes de management de la qualité - Impositions particulières pour leur application à la production de combustibles solides de récupération

Feste Sekundärbrennstoffe - Qualitätsmanagementsysteme - Besondere Anforderungen für die Anwendung bei der Herstellung von festen Sekundärbrennstoffen This European Standard was approved by CEN on 22 January 2011.

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 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 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 versions.

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, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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 CEN national Members. Ref. No. EN 15358:2011: ESIST EN 15358:2011

EN 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 requirements ...............................................................................................................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 ............................................................................................. 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 ....................................................................................................................... 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 ............................................................................................................. 207.2.1 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 ..................................................................................................... 23SIST EN 15358:2011

EN 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 Verification 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 ...................................................................................................................... 307.6 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 ......................................................................................................................... 338.2.2 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 ...................................................................................................................... 378.5.2 Corrective action ................................................................................................................................. 388.5.3 Preventive action ................................................................................................................................. 39Bibliography ...................................................................................................................................................... 40 SIST EN 15358:2011

EN 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 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 15358:2006 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 by 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, 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.

SIST EN 15358:2011

EN 15358:2011 (E) 5 Introduction In the context of solid 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 good 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 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 used 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 this 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 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. 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 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 for dealing with failures, and self-improvement; g) procedures for the development of the processing. SIST EN 15358:2011

EN 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 sector-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” is used, any suggestions given are for guidance only. SIST EN 15358:2011

EN 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 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 edition 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/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 terms and definitions given in EN ISO 9000:2005, EN 15357:2011 and the following apply. 3.1 product realization production of solid recovered fuels SIST EN 15358:2011

EN 15358:2011 (E) 8 4
Quality management system 4.1
General requirements EN ISO 9001:2008, Quality management systems – Requirements

4 Quality 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 processes 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 availability 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 be 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 applied 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. NOTE 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 to 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 organization’s capability to provide product that conforms to requirements, b) the to which the control for the process is shared, c) the capability of achieving the necessary control through the application of 7.4. SIST EN 15358:2011

EN 15358:2011 (E) 9
4.1.1

General The organization shall establish and maintain a programme for achieving its objectives and targets. It shall specify: 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 or 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 preventive actions. Any corrective or preventive action taken to eliminate the causes of actual and potential non-conformities shall be appropriate to the magnitude of the problems and commensurate with the quality impact encountered. The organization shall implement and record any changes in the documented procedures resulting from corrective and preventive actions. The supplier of solid recovered fuels is responsible for the conformity with the agreed specification. The quality management system shall be as comprehensive as is necessary to meet the quality objectives and shall be included in quality systems of different operators in the production chain. The responsibility for the inputs, the partly-processed materials and/or the finished solid recovered fuels in the different parts of the production chain shall be transferred to the next operator in the chain, and eventually to the end user as soon as it has been accepted that the material correspond to the quality agreed between the parties. 4.1.2

Outsourced processes Among the outsourced processes, the transport of input waste and of solid recovered fuels and the selection and control of laboratories for analysis should be managed according to documented procedures. Other outsourced processes should be managed in line with in-house processes. 4.2

Documentation requirements 4.2.1

General EN ISO 9001:2008, Quality management systems - Requirements 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, SIST EN 15358:2011

EN 15358:2011 (E) 10 c) documented procedures and records required by this International Standard, and d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes. NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium. 4.2.2

Quality manual EN ISO 9001:2008, Quality management systems - Requirements 4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusions, b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. The quality manual is a document prepared by the organization that systematically defines procedures needed to implement a quality management system for a solid recovered fuels supply chain. The quality manual is a tool to demonstrate to all parties (producers, customers, authorities, other interested organizations, etc.) how the requirements are fulfilled. 4.2.3

Control of documents EN ISO 9001:2008, Quality management systems - Requirements 4.2.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, SIST EN 15358:2011

EN 15358:2011 (E) 11 e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 4.2.4

Control of records EN ISO 9001:2008, Quality management systems - Requirements 4.2.4 Control of records Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

The organization shall establish a document procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records shall remain legible, readily identifiable and retrievable. 5

Management responsibility 5.1

Management commitment EN ISO 9001:2008, Quality management systems – Requirements 5 Management responsibility 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 5.2

Customer focus EN ISO 9001:2008, Quality man
...

SLOVENSKI SIST EN 15358
STANDARD
maj 2011
Trdna alternativna goriva – Sistemi vodenja kakovosti – Posebne zahteve za
njihovo uporabo pri proizvodnji trdnih alternativnih goriv
Solid recovered fuels – Quality management systems – Particular requirements
for their application to the production of solid recovered fuels
Combustibles solides de récupération – Systèmes de management de la qualité

– Impositions particulières pour leur application à la production de combustibles

solides de récupération
Feste Sekundärbrennstoffe – Qualitätsmanagementsysteme – Besondere
Anforderungen für die Anwendung bei der Herstellung von festen
Sekundärbrennstoffen
Referenčna oznaka
ICS 03.120.99; 75.160.10 SIST EN 15358:2011 (sl)
Nadaljevanje na straneh II in od 1 do 35

© 2014-01 Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 15358 : 2011
NACIONALNI UVOD

Standard SIST EN 15358 (sl), Trdna alternativna goriva – Sistemi vodenja kakovosti – Posebne zahteve za

njihovo uporabo pri proizvodnji trdnih alternativnih goriv, 2011, ima status slovenskega standarda in je

istoveten evropskemu standardu EN 15358 (en), Solid recovered fuels – Quality management systems –

Particular requirements for their application to the production of solid recovered fuels, 2011.

NACIONALNI PREDGOVOR

Besedilo standarda EN 15358:2011 je pripravil tehnični odbor CEN/TC 343 Trdna alternativna goriva,

katerega sekretariat vodi SFS. Slovenski standard SIST EN 15358:2011 je prevod angleškega

besedila evropskega standarda EN 15358:2011. V primeru spora glede besedila slovenskega prevoda

v tem standardu je odločilen izvirni evropski standard v angleškem jeziku.

Odločitev za izdajo tega dokumenta je dne 4. aprila 2011 sprejel SIST/TC AGO Alternativna goriva iz

odpadkov.
ZVEZE S STANDARDI

S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi

standardi, navedeni v izvirniku, razen standardov, ki so že sprejeti v nacionalno standardizacijo:

SIST EN 15357:2011 (en) Trdna alternativna goriva – Terminologija, definicije in opisi

SIST EN 15359:2012 (en) Trdna alternativna goriva – Specifikacije in razredi

SIST EN ISO 9000:2005 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2005)

SIST EN ISO/IEC 17020:2012 (sl,en) Ugotavljanje skladnosti – Zahteve za delovanje različnih

organov, ki izvajajo kontrolo (ISO/IEC 17020:2012)

SIST EN ISO/IEC 17025:2005 (sl,en) Splošne zahteve za usposobljenost preskuševalnih in

kalibracijskih laboratorijev (ISO/IEC 17025:2005)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN 15358:2011.
PREDHODNA IZDAJA
– SIST-TS CEN/TS 15358:2007.
OPOMBE

– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN 15358:2011

to pomeni “slovenski standard”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN 15358:2011 in je objavljen z dovoljenjem

CEN
Avenue Marnix 17
B 1000 Bruselj
Belgija

This national document is identical with EN 15358:2011 and is published with the permission of

CEN
Avenue Marnix 17
B 1000 Bruxelles
Belgium
---------------------- Page: 2 ----------------------
EVROPSKI STANDARD EN 15358
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM marec 2011
ICS 75.160.10 Nadomešča CEN/TS 15358:2006
Slovenska izdaja

Trdna alternativna goriva – Sistemi vodenja kakovosti – Posebne zahteve za njihovo

uporabo pri proizvodnji trdnih alternativnih goriv

Solid recovered fuels – Quality Combustibles solides de récupération Feste Sekundärbrennstoffe –

management systems – – Systèmes de management de la Qualitätsmanagementsysteme –

Particular requirements for their qualité – Impositions particulières Besondere Anforderungen für die

application to the production of pour leur application à la production Anwendung bei der Herstellung

solid recovered fuels de combustibles solides de von festen Sekundärbrennstoffen
récupération
Ta evropski standard je CEN sprejel dne 22. januarja 2011.

Člani CEN morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je predpisano,

da mora biti ta evropski standard brez kakršnihkoli sprememb sprejet kot nacionalni standard.

Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na voljo pri

Upravnem centru CEN/CENELEC ali članih CEN.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih

jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru

CEN/CENELEC, veljajo kot uradne izdaje.

Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,

Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve,

Luksemburga, Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije,

Slovaške, Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
Upravni center: Avenue Marnix 17, B-1000 Bruselj

© 2011 CEN Lastnice avtorskih pravic so vse države članice CEN Ref. oznaka EN 15358:2011 E

---------------------- Page: 3 ----------------------
SIST EN 15358 : 2011
Vsebina Stran

Predgovor .................................................................................................................................................4

Uvod .........................................................................................................................................................5

1 Področje uporabe .................................................................................................................................6

2 Zveze s standardi .................................................................................................................................6

3 Izrazi in definicije ..................................................................................................................................6

4 Sistem vodenja kakovosti.....................................................................................................................7

4.1 Splošne zahteve................................................................................................................................7

4.1.1 Splošno...........................................................................................................................................7

4.1.2 Procesi, predani v izvajanje zunanjim izvajalcem ..........................................................................8

4.2 Zahteve glede dokumentacije ...........................................................................................................8

4.2.1 Splošno...........................................................................................................................................8

4.2.2 Poslovnik kakovosti ........................................................................................................................8

4.2.3 Obvladovanje dokumentov.............................................................................................................9

4.2.4 Obvladovanje zapisov ....................................................................................................................9

5 Odgovornost vodstva............................................................................................................................9

5.1 Zavezanost vodstva...........................................................................................................................9

5.2 Osredotočenost na odjemalce.........................................................................................................10

5.3 Politika kakovosti.............................................................................................................................10

5.4 Planiranje.........................................................................................................................................10

5.4.1 Cilji kakovosti................................................................................................................................10

5.4.2 Planiranje sistema vodenja kakovosti ..........................................................................................11

5.5 Odgovornosti, pooblastila in komuniciranje.....................................................................................12

5.5.1 Odgovornosti in pooblastila ..........................................................................................................12

5.5.2 Predstavnik vodstva .....................................................................................................................12

5.5.3 Notranje komuniciranje.................................................................................................................12

5.6 Vodstveni pregled............................................................................................................................13

5.6.1 Splošno.........................................................................................................................................13

5.6.2 Vhodni podatki za pregled............................................................................................................13

5.6.3 Rezultat pregleda .........................................................................................................................13

6 Vodenje virov......................................................................................................................................14

6.1 Priskrba virov...................................................................................................................................14

6.2 Človeški viri .....................................................................................................................................14

6.2.1 Splošno.........................................................................................................................................14

6.2.2 Kompetentnost, zavedanje in usposabljanje................................................................................14

6.3 Infrastruktura ...................................................................................................................................15

6.4 Delovno okolje.................................................................................................................................15

7 Realizacija proizvoda..........................................................................................................................16

7.1 Planiranje realizacije proizvoda.......................................................................................................16

7.1.1 Validacija proizvoda in procesa....................................................................................................16

7.1.2 Obvladovanje sprememb .............................................................................................................16

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SIST EN 15358 : 2011

7.2 Procesi, povezani z odjemalci.........................................................................................................16

7.2.1 Določitev zahtev v zvezi s proizvodom.........................................................................................16

7.2.2 Pregled zahtev v zvezi s proizvodom...........................................................................................17

7.2.3 Komuniciranje z odjemalci............................................................................................................17

7.3 Snovanje in razvoj ...........................................................................................................................18

7.3.1 Planiranje snovanja in razvoja......................................................................................................18

7.3.2 Vhodi za snovanje in razvoj..........................................................................................................18

7.3.3 Rezultati snovanja in razvoja........................................................................................................19

7.3.4 Pregled snovanja in razvoja ........................................................................................................20

7.3.5 Overjanje snovanja in razvoja ......................................................................................................20

7.3.6 Validacija snovanja in razvoja ......................................................................................................20

7.3.7 Obvladovanje sprememb snovanja in razvoja ............................................................................20

7.4 Nabava ...........................................................................................................................................21

7.4.1 Proces nabave .............................................................................................................................21

7.4.2 Informacije za nabavo .................................................................................................................22

7.4.3 Overjanje nabavljenih proizvodov ...............................................................................................22

7.5 Proizvodnja in izvedba storitev .......................................................................................................23

7.5.1 Obvladovanje proizvodnje in izvedbe storitev .............................................................................23

7.5.2 Validacija procesov za proizvodnjo in izvedbo storitev ...............................................................24

7.5.3 Identifikacija in sledljivost ............................................................................................................25

7.5.4 Lastnina odjemalcev ....................................................................................................................25

7.5.5 Ohranitev proizvoda ....................................................................................................................25

7.6 Obvladovanje nadzornih in merilnih naprav ...................................................................................25

7.6.1 Analiza merilnega sistema ..........................................................................................................26

7.6.2 Zapisi o kalibraciji/overjanju ........................................................................................................26

7.6.3 Zahteve za laboratorije/vzorčenje ...............................................................................................26

8 Merjenje, analize in izboljševanje ......................................................................................................27

8.1 Splošno............................................................................................................................................27

8.2 Nadzorovanje in merjenje ...............................................................................................................27

8.2.1 Zadovoljstvo odjemalcev .............................................................................................................27

8.2.2 Notranja presoja ..........................................................................................................................28

8.2.3 Nadzorovanje in merjenje procesov ............................................................................................29

8.2.4 Nadzorovanje in merjenje proizvodov .........................................................................................29

8.3 Obvladovanje neskladnih proizvodov .............................................................................................30

8.3.1 Obvladovanje predelanih proizvodov ..........................................................................................30

8.3.2 Obveščanje odjemalcev ..............................................................................................................30

8.4 Analiza podatkov ............................................................................................................................31

8.5 Izboljševanje ...................................................................................................................................32

8.5 1 Nenehno izboljševanje ................................................................................................................32

8.5.2 Korektivni ukrepi ..........................................................................................................................32

8.5.3 Preventivni ukrepi ........................................................................................................................33

Literatura.................................................................................................................................................34

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SIST EN 15358 : 2011
Predgovor

Ta dokument (EN 15358:2011) je pripravil tehnični odbor CEN/TC 343 "Trdna alternativna goriva",

katerega sekretariat vodi SFS.

Ta evropski standard mora dobiti status nacionalnega standarda bodisi z objavo istovetnega besedila

ali z razglasitvijo najpozneje septembra 2011, nasprotujoče nacionalne standarde pa je treba

razveljaviti najpozneje septembra 2011.
Ta dokument nadomešča CEN/TS 15358:2006.
Ta dokument se od CEN/TS 15358:2006 razlikuje le uredniško.

Opozoriti je treba na možnost, da so lahko nekateri elementi tega dokumenta predmet patentnih

pravic. CEN [in/ali CENELEC] ne prevzema odgovornosti za identifikacijo nekaterih ali vseh takih

patentnih pravic.

Ta dokument je bil pripravljen v okviru mandata, ki sta ga CEN dala Evropska komisija in Evropsko

združenje za prosto trgovino (EFTA).

V skladu z notranjimi predpisi CEN/CENELEC morajo ta evropski standard obvezno uvesti nacionalne

organizacije za standardizacijo naslednjih držav: Avstrije, Belgije, Bolgarije, Cipra, Češke republike,

Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve,

Luksemburga, Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije,

Slovaške, Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
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SIST EN 15358 : 2011
Uvod

V okviru proizvodnje trdnih alternativnih goriv (TAG) temelji strategija vodenja kakovosti predvsem na

dejstvu, da se lahko z boljšim poznavanjem celotnega procesa proizvodnje zmanjša količina vzorčenja

in preskušanja, ki ga je treba izvesti na končnih proizvodih. Za to strategijo so značilni dobri postopki

vodenja kakovosti v procesu izdelave, vključno z dobrim vodenjem zapisov. V okviru trdnih

alternativnih goriv vodenje kakovosti zagotavlja način, s katerim se lahko pridobi in ohrani zaupanje

odjemalcev ter upravnih organov.

Cilj tega evropskega standarda je razvoj sistema vodenja kakovosti za proizvodnjo trdnih alternativnih

goriv in trgovanje z njimi, ki zagotavlja nenehno izboljševanje, pri čemer je poudarek na izpolnjevanju

zahtev v zvezi s kakovostjo.

Ta evropski standard je podlaga za razvoj sistema vodenja kakovosti za dobavno organizacijo trdnih

alternativnih goriv, ki pred tem še ni vzpostavila sistema vodenja kakovosti. Uporabi se lahko tudi kot

podporni dokument za dobavitelja, ki že ima vzpostavljen sistem vodenja kakovosti.

Ta evropski standard v povezavi z veljavnimi posebnimi zahtevami odjemalcev in zvezami s standardi

iz točke 2 določa temeljne zahteve za sistem vodenja kakovosti za tiste, ki so nanj pristali. Razvoj

sistema vodenja kakovosti za trdna alternativna goriva, ki temelji na tem evropskem standardu, ne

zajema obveznega certificiranja skladnosti, ki ga izvaja tretja stranka, vendar je to certificiranje

priporočeno.
Ta evropski standard se osredotoča na:

1) povečanje zaupanja v proizvodnjo in trgovanje s trdnimi alternativnimi gorivi;

2) določitev dokumentacije, ki jo je treba uporabiti za notranje postopke, in obveščanje vseh

udeleženih strank o potrebnih specifikacijah za izpolnitev ciljev kakovosti;

3) overjanje izvora in dokazovanje lastnosti vhodnih materialov (npr. nenevarni odpadki).

Sistemi vodenja kakovosti so v skladu s standardom EN ISO 9001, pri čemer zajemajo celoten proces

od trenutka sprejema odpadkov do trenutka, ko je trdno alternativno gorivo dobavljeno odjemalcu.

Sistemi vodenja kakovosti imajo številne pomembne funkcije, vključno z določanjem:

a) ključnih korakov v procesu;

b) oseb, ki so odgovorne za posamezen korak procesa in za splošno koordinacijo vodenja

kakovosti;
c) izobraževanja – politik in postopkov za izvedbo;
d) postopkov za proizvodnjo;
e) postopkov za vodenje zapisov za zagotavljanje popolne sledljivosti;
f) postopkov za obravnavo napak in postopkov za samoizboljševanje;
g) postopkov za razvoj obdelave.

Za doseganje skladnosti z notranjimi predpisi CEN za osnutke dokumentov se v tem evropskem

standardu za prvotno besedilo standarda EN ISO 9001:2008 uporablja besedilo v okvirčkih, dodatne

zahteve, specifične za področje, pa so zapisane zunaj okvirčkov.

V tem standardu beseda »morati« pomeni zahtevo, beseda »naj« pa pomeni priporočilo.

Odstavki, označeni z »OPOMBA«, so napotki za razumevanje ali pojasnilo zahteve.
Kjer je uporabljen izraz »kot je/so«, so vse navedbe podane samo kot napotki.
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SIST EN 15358 : 2011
1 Področje uporabe

Ta evropski standard določa zahteve za sistem vodenja kakovosti za proizvodnjo trdnih alternativnih

goriv in trgovanje z njimi od sprejema odpadkov do dostave trdnih alternativnih goriv (slika 1).

Slika 1: Sistemi vodenja kakovosti v verigi trdnih alternativnih goriv
2 Zveze s standardi

Za uporabo tega dokumenta so nujni naslednji referenčni dokumenti. Pri datiranih sklicevanjih se

uporablja samo navedena izdaja. Pri nedatiranih sklicevanjih se uporablja zadnja izdaja referenčnega

dokumenta (vključno z morebitnimi dopolnili).
EN 15357:2011 Trdna alternativna goriva – Terminologija, definicije in opisi
EN 15359 Trdna alternativna goriva – Specifikacije in razredi
EN ISO 9000:2005 Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2005)

EN ISO/IEC 17020 Splošna merila za delovanje različnih organov, ki izvajajo kontrolo

(ISO/IEC 17020:1998)

EN ISO/IEC 17025 Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih

laboratorijev (ISO/IEC 17025:2005)
3 Izrazi in definicije

V tem dokumentu se uporabljajo izrazi in definicije, navedeni v standardih EN ISO 9000:2005 in

EN 15357:2011, ter naslednji izraz in definicija:
3.1
realizacija proizvoda
proizvodnja trdnih alternativnih goriv
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SIST EN 15358 : 2011
4 Sistem vodenja kakovosti
4.1 Splošne zahteve
EN ISO 9001:2008, Sistemi vodenja kakovosti – Zahteve
4 Sistem vodenja kakovosti
4.1 Splošne zahteve

Organizacija mora vzpostaviti, dokumentirati, izvajati in vzdrževati sistem vodenja kakovosti ter nenehno

izboljševati njegovo uspešnost v skladu z zahtevami tega mednarodnega standarda.
Organizacija mora:

a) določiti procese, potrebne za sistem vodenja kakovosti, in njihovo uporabo v celotni organizaciji,

b) določiti zaporedje in medsebojne vplive teh procesov,

c) določiti kriterije in metode, potrebne za zagotovitev tako uspešnega delovanja kot tudi uspešnega

obvladovanja teh procesov,

d) zagotoviti, da so na voljo viri in informacije, potrebne za podporo delovanja in nadzorovanja teh procesov,

e) nadzorovati, meriti, kjer je to primerno, in analizirati te procese in

f) izvajati ukrepe, potrebne za doseganje planiranih rezultatov in za nenehno izboljševanje teh procesov.

Organizacija mora voditi te procese skladno z zahtevami tega mednarodnega standarda.

V primeru, da se organizacija odloči predati zunanjim izvajalcem v izvajanje katerikoli proces, ki vpliva na

skladnost proizvoda z zahtevami, mora organizacija zagotoviti obvladovanje teh procesov. Vrsta in obseg

obvladovanja teh procesov morata biti določena s sistemom vodenja kakovosti.

OPOMBA 1: Procesi, potrebni za sistem vodenja kakovosti, na katere se sklicuje zgornje besedilo, vključujejo procese za

vodstvene aktivnosti, priskrbo virov, realizacijo proizvoda, merjenje, analize in izboljševanje.

OPOMBA 2: Proces, predan v izvajanje zunanjim izvajalcem, je proces, ki ga organizacija potrebuje za njen sistem

vodenja kakovosti in za katerega se odloči, da ga bo izvajala zunanja stranka.

OPOMBA 3: Zagotavljanje obvladovanja procesov, predanih v izvajanje zunanjim izvajalcem, ne razbremeni organizacije

od odgovornosti za skladnost z vsemi zahtevami odjemalcev, zakonodaje in regulative. Na vrsto in obseg

obvladovanja procesa, predanega v izvajanje zunanjim izvajalcem, lahko vplivajo dejavniki, kot na primer:

a) potencialni vpliv procesa, predanega v izvajanje zunanjim izvajalcem, na sposobnost organizacije

zagotavljati proizvod, ki je skladen z zahtevami;
b) stopnja, do katere je obvladovanje procesa deljeno;
c) sposobnost doseganja potrebnega obvladovanja z uporabo točke 7.4.
4.1.1 Splošno

Organizacija mora vzpostaviti in vzdrževati program za doseganje svojih okvirnih in izvedbenih ciljev.

Program mora določiti:

a) odgovornosti imenovanega osebja za doseganje okvirnih in izvedbenih ciljev na posameznih

funkcijah in ravneh znotraj organizacije;
b) sredstva in časovne okvire, v katerih je treba zastavljene cilje doseči.

Če se v projekt uvedejo novosti in nove ali spremenjene aktivnosti, proizvodi ali storitve, je treba

programe pregledati in jih po potrebi spremeniti, pri čemer se zagotovi ustrezna uporaba sistema

vodenja kakovosti pri takšnih projektih.

Organizacija mora vzpostaviti in vzdrževati notranje postopke za določitev odgovornosti in pooblastil

za obravnavo in preiskavo neskladnosti, ukrepanje za zmanjšanje morebitnih nastalih vplivov ter

začetek in izvedbo korektivnih ter preventivnih ukrepov.

Morebitni korektivni ali preventivni ukrep za odpravljanje vzrokov dejanskih in potencialnih

neskladnosti mora biti sorazmeren s težo problemov in ustrezati nastalemu vplivu na kakovost.

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SIST EN 15358 : 2011

Organizacija mora izvesti in zapisati vse spremembe dokumentiranih postopkov, ki so posledica

korektivnih in preventivnih ukrepov.

Dobavitelj trdnih alternativnih goriv je odgovoren za skladnost z dogovorjeno specifikacijo. Sistem

vodenja kakovosti mora biti tako izčrpen, kot je to potrebno za izpolnjevanje ciljev kakovosti ter mora

biti vključen v sisteme kakovosti različnih izvajalcev v proizvodni verigi.

Odgovornost za vhode, delno predelane materiale in/ali proizvedena trdna alternativna goriva v

različnih delih proizvodne verige je treba prenesti na naslednjega izvajalca v verigi ter sčasoma na

končnega uporabnika, in sicer takoj, ko je potrjeno, da material ustreza kakovosti, dogovorjeni med

strankami.
4.1.2 Procesi, predani v izvajanje zunanjim izvajalcem

Med procesi, predanimi v izvajanje zunanjim izvajalcem, naj se transport vhodnih odpadkov in trdnih

alternativnih goriv ter izbor in obvladovanje laboratorijev za analizo vodi v skladu z dokumentiranimi postopki.

Drugi procesi, predani v izvajanje zunanjim izvajalcem, naj se vodijo v skladu z notranjimi procesi.

4.2 Zahteve glede dokumentacije
4.2.1 Splošno
EN ISO 9001:2008, Sistemi vodenja kakovosti – Zahteve
4.2 Zahteve glede dokumentacije
4.2.1 Splošno
Dokumentacija sistema vodenja kakovosti mora vključevati:
a) dokumentirane izjave o politiki kakovosti in ciljih kakovosti,
b) poslovnik kakovosti,
c) dokumentirane postopke in zapise, ki jih zahteva ta mednarodni standard, in

d) dokumente, vključno z zapisi, ki jih je organizacija določila kot potrebne, da bi zagotovila uspešno

planiranje, delovanje in obvladovanje njenih procesov.

OPOMBA 1: Kjer se v tem mednarodnem standardu pojavlja izraz »dokumentiran postopek«, to pomeni, da je postopek

vzpostavljen, dokumentiran, da se izvaja in vzdržuje. En sam dokument se lahko nanaša na zahteve enega

ali več postopkov. Zahtevani dokumentirani postopek se lahko nahaja v več kot samo enem dokumentu.

OPOMBA 2: Obseg dokumentacije sistema vodenja kakovosti se lahko razlikuje od ene do druge organizacije zaradi:

a) velikosti organizacije in vrste aktivnosti,
b) kompleksnosti procesov in njihovih medsebojnih vplivov,
c) kompetentnosti osebja.
OPOMBA 3: Dokumentacija je lahko v kakršnikoli obliki ali v kateremkoli mediju.
4.2.2 Poslovnik kakovosti
EN ISO 9001:2008, Sistemi vodenja kakovosti – Zahteve
4.2.2 Poslovnik kakovosti
Organizacija mora izdelati in vzdrževati poslovnik kakovosti, ki vključuje:

a) predmet sistema vodenja kakovosti, vključno z razlogi in s podrobnostmi glede morebitnih opustitev,

b) dokumentirane postopke, vzpostavljene za sistem vodenja kakovosti, ali sklicevanje nanje,

c) opis medsebojnega vpliva pr
...

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