DIN EN 15267-2-2009 Air quality - Certification of automated measuring systems - Part 2 Initial assessment of the AMS manufacturers quality management system and post certification.pdf

1、July 2009DEUTSCHE NORM English price group 11No 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 13.040.99!$Xto“1538176www

2、.din.deDDIN EN 15267-2Air quality Certification of automated measuring systems Part 2: Initial assessment of the AMS manufacturers qualitymanagement system and post certification surveillance for themanufacturing processEnglish version of DIN EN 15267-2:2009-07Luftbeschaffenheit Zertifizierung von a

3、utomatischen Messeinrichtungen Teil 2: Erstmalige Beurteilung des Qualittsmanagementsystems des Herstellers undberwachung des Herstellungsprozesses nach der ZertifizierungEnglische Fassung DIN EN 15267-2:2009-07www.beuth.deDocument comprises 19 pagesThis standard has been included in the VDI/DIN Han

4、dbook on air quality, Volume 5.2 National foreword This standard has been prepared by Technical Committee CEN/TC 264 “Air quality”, Working Group WG 22 “Certification scheme for AMS” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Kommission Reinhaltung d

5、er Luft (KRdL) im VDI und DIN (Commission on Air Pollution Prevention of VDI and DIN Standards Committee), Section IV Umweltmesstechnik. DIN EN 15267-2:2009-07 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15267-2 March 2009 ICS 13.040.99 English Version Air quality Certification of automated

6、 measuring systems Part 2: Initial assessment of the AMS manufacturers quality management system and post certification surveillance for the manufacturing process Qualit de lair Certification des systmes de mesurage automatiss Partie 2: Evaluation initiale du systme de gestion de la qualit des fabri

7、cants dAMS et surveillance aprs certification du procd de fabrication Luftbeschaffenheit Zertifizierung von automatischen Messeinrichtungen Teil 2: Erstmalige Beurteilung des Qualittsmanagementsystems des Herstellers und berwachung des Herstellungsprozesses nach der Zertifizierung This European Stan

8、dard was approved by CEN on 14 February 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning

9、 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 language made by translation under the responsibility of a CEN member into its own lan

10、guage 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, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lu

11、xembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All ri

12、ghts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15267-2:2009: EEN 15267-2:2009 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Quality management systems 7 4.1 General requiremen

13、ts 7 4.2 Documentation requirements .7 5 Management responsibility 8 5.1 Management commitment 8 5.2 Customer focus 8 5.3 Quality policy .8 5.4 Planning 8 5.5 Responsibility, authority and communication 9 5.6 Management review .9 6 Resource management 10 6.1 Provision of resources . 10 6.2 Human res

14、ources 10 6.3 Infrastructure . 10 6.4 Work environment 10 7 Product realisation . 10 7.1 Planning of product realisation . 10 7.2 Customer-related processes . 10 7.3 Design and development . 11 7.4 Purchasing 12 7.5 Production and service provision . 13 7.6 Control of monitoring and measuring device

15、s 13 8 Measurement, analysis and improvement . 13 8.1 General . 13 8.2 Monitoring and measurement . 13 8.3 Control of non-conforming product 14 8.4 Analysis of data 14 8.5 Improvement . 14 9 Assessment . 15 9.1 Initial assessment . 15 9.2 Continuing surveillance . 15 Annex A (informative) Process fo

16、r the control and assessment of design changes 16 Bibliography . 17 DIN EN 15267-2:2009-07 EN 15267-2:2009 (E) 3 Foreword This document (EN 15267-2:2009) has been prepared by Technical Committee CEN/TC 264 “Air quality”, the secretariat of which is held by DIN. This European Standard shall be given

17、the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2009, and conflicting national standards shall be withdrawn at the latest by September 2009. Attention is drawn to the possibility that some of the elements of this document ma

18、y 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 is Part 2 of a series of European Standards: EN 15267-1, Air quality Certification of automated measuring systems Part 1: General principles EN 15267-2, Ai

19、r quality Certification of automated measuring systems Part 2: Initial assessment of the AMS manufacturers quality management system and post certification surveillance for the manufacturing process EN 15267-3, Air quality Certification of automated measuring systems Part 3: Performance criteria and

20、 test procedures for automated measuring systems for monitoring emissions from stationary sources 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, Cyprus, Czec

21、h 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 the United Kingdom. DIN EN 15267-2:2009-07 EN 15267-2:2009 (E) 4

22、Introduction The product certification of automated measuring systems (AMS) supports the requirements of certain Directives of the European Union (EU), which require, either directly or indirectly, that AMS comply with performance criteria, maximum permissible measurement uncertainties and testing r

23、equirements. These Directives include the Directive on the limitation of emissions of certain pollutants into the air from large combustion plants 1, the Directive on the incineration of waste 2 and the Framework Directive on ambient air quality assessment and management 3 and the associated daughte

24、r directives 4, 5, 6 and 7. An AMS will typically undergo design changes during its product life. It is essential to ensure that such changes do not alter the AMS such that it no longer conforms with its certified performance. In order to control such design changes for the product certification of

25、AMS this European Standard specifies the requirements for the manufacturers quality management system, the initial assessment of an AMS manufacturers production control, and the continuing surveillance of the effect on performance of certified AMS of subsequent design changes. This European Standard

26、 follows the structure of EN ISO 9001:2000 such that clause numbers in Clauses 4 to 8 of this standard coincide with those of EN ISO 9001:2000. However, this European Standard does not preclude the use of other quality management systems that are compatible with the objectives of EN ISO 9001:2000. D

27、IN EN 15267-2:2009-07 EN 15267-2:2009 (E) 5 1 Scope This European Standard specifies the requirements for the manufacturers quality management system, the initial assessment of the manufacturers production control and the continuing surveillance of the effect of subsequent design changes on the perf

28、ormance of certified automated measuring systems. This European Standard also serves as a reference document for auditing the manufacturers quality management system. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated reference

29、s, 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) EN ISO/IEC 17021, Conformity assessment Requirements for bodies providing audit and c

30、ertification of management systems (ISO/IEC 17021:2006) 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 following terms and definitions apply. 3.1 automated measuring

31、 system AMS entirety of all measuring instruments and additional devices for obtaining a result of measurement NOTE 1 Apart from the actual measuring device (the analyser), an AMS includes facilities for taking samples (e.g. probe, sample gas lines, flow meters and regulator, delivery pump) and for

32、sample conditioning (e.g. dust filter, pre-separator for interferents, cooler, converter). This definition also includes testing and adjusting devices that are required for functional checks and, if applicable, for commissioning. NOTE 2 The term “automated measuring system” (AMS) is typically used i

33、n Europe. The terms “continuous emission monitoring system” (CEM) and “continuous ambient-air-quality monitoring system” (CAM) are also typically used in the UK and USA. EN 15267-1:2008, 3.1 3.2 relevant body competent authority or certification body, nominated by a competent authority or EU member

34、state, that carries out the certification of automated measuring systems EN 15267-1:2008, 3.2 3.3 competent authority organisation which implements the requirements of EU Directives and regulates installations, which must comply with the requirements of applicable European Standards EN 15267-1:2008,

35、 3.3 DIN EN 15267-2:2009-07 EN 15267-2:2009 (E) 6 3.4 certification body any body operating a product certification system or any body accredited to EN ISO/IEC 17021 for the certification of quality management systems EN 15267-1:2008, 3.4 3.5 manufacturer organisation, situated at a stated location

36、or locations, that carries out or controls such stages in the manufacture, assessment, handling and storage of a product that enables it to accept responsibility for continued compliance of the product and its certification, and undertakes all obligations in that connection NOTE The term “manufactur

37、er“ is used instead of “organisation“ as used in EN ISO 9001. For the purpose of this document they are interchangeable. EN 15267-1:2008, 3.5 3.6 test laboratory laboratory accredited to EN ISO/IEC 17025 for carrying out performance tests on automated measuring systems in accordance with applicable

38、European Standards EN 15267-1:2008, 3.6 3.7 product automated measuring system EN 15267-1:2008, 3.7 3.8 technical documentation information for the operation of automated measuring systems, such as manuals 3.9 technical file record of the reference documents and design changes to the reference docum

39、ents EN 15267-1:2008, 3.8 3.10 reference document document that controls the manufacture and design of an AMS and is referenced in the test report NOTE Reference documents can include drawings, specifications, instructions and computer code. EN 15267-1:2008, 3.9 3.11 related document document not re

40、ferenced in the test report NOTE A related document can be used, for example, for the detailed manufacture of component parts. EN 15267-1:2008, 3.10 DIN EN 15267-2:2009-07 EN 15267-2:2009 (E) 7 3.12 certification range range over which the automated measuring system is tested and certified for compl

41、iance with the relevant performance criteria NOTE 1 The lower limit is typically the detection limit of the AMS and often considered to be zero. NOTE 2 Generally, the lower the certification range, the better the performance of the AMS. Also an AMS typically performs satisfactorily at higher values

42、over the measurement range. EN 15267-1:2008, 3.11 3.13 surveillance systematic iteration of conformity assessment activities as a basis for maintaining the validity of the statement of conformity NOTE For the purposes of this European Standard surveillance focuses on the manufacturers quality manage

43、ment system to ensure that automated measuring systems continue to comply with the standard to which they are certified. EN 15267-1:2008, 3.12 3.14 legislation directives, acts, ordinances and regulations EN 15267-1:2008, 3.13 4 Quality management systems 4.1 General requirements The manufacturers q

44、uality management system shall ensure compliance of all automated measuring systems, of the type that has been product certified, with the performance criteria specified in the relevant certificate. 4.2 Documentation requirements 4.2.1 General The requirements specified in 4.2.1 of EN ISO 9001:2000

45、apply. The manufacturer shall have methods to keep up-to-date with the requirements of legislation, standards and guidelines that are relevant to its certified AMS and AMS for which it seeks certification in accordance with the EN 15267 series of standards. 4.2.2 Quality manual The requirements spec

46、ified in 4.2.2 of EN ISO 9001:2000 apply. The quality management system manual shall ensure that no factor (e.g. measured components, scope) defined within the AMS certificate and technical documentation (e.g. reference documents) is modified without appropriate evaluation of its impact on the perfo

47、rmance of the AMS. DIN EN 15267-2:2009-07 EN 15267-2:2009 (E) 8 4.2.3 Control of documents The requirements specified in 4.2.3 of EN ISO 9001:2000 apply. Documents that control the manufacture and design of AMS are referred to as reference documents. They can include drawings, specifications, instru

48、ctions and computer code. The AMS manufacturer shall ensure that all related documents are cross-referenced to the relevant reference documents for the AMS. Where there are common reference documents associated with more than one AMS certificate, the manufacturer shall have methods to ensure simulta

49、neous supplementary action in the event of an amendment to such documents. Where a manufacturer also has documents for AMS not intended for testing and certification, then the manufacturer shall have a method that enables both the related documents and reference documents to be clearly identified. The AMS manufacturer shall either retain, or have access to any legislation and CEN standards which contains performance criteria for AMS. 4.2.4 Control of records The requirements specif