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

1、BS EN15267-2:2009ICS 13.040.99NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDAir quality Certification ofautomated measuringsystemsPart 2: Initial assessment of the AMSmanufacturers quality managementsystem and post certificationsurveillance for the manufacturi

2、ngprocessThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 April2009 BSI 2009ISBN 978 0 580 57915 8Amendments/corrigenda issued since publicationDate CommentsBS EN 15267-2:2009National forewordThis British Standard is the UK implementation of EN

3、 15267-2:2009.The UK participation in its preparation was entrusted to TechnicalCommittee EH/2/1, Stationary source emission.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a

4、contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS EN 15267-2:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 15267-2March 2009ICS 13.040.99English VersionAir quality - Certification of automated measur

5、ing systems - Part2: Initial assessment of the AMS manufacturers qualitymanagement system and post certification surveillance for themanufacturing processQualit de lair - Certification des systmes de mesurageautomatiss - Partie 2 : Evaluation initiale du systme degestion de la qualit des fabricants

6、dAMS et surveillanceaprs certification du procd de fabricationLuftbeschaffenheit - Zertifizierung von automatischenMesseinrichtungen - Teil 2: Erstmalige Beurteilung desQualittsmanagementsystems des Herstellers undberwachung des Herstellungsprozesses nach derZertifizierungThis European Standard was

7、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 such nati

8、onalstandards 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 translationunder the responsibility of a CEN member into its own language and not

9、ified 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, Luxembourg, Malt

10、a, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitati

11、on in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 15267-2:2009: EBS EN 15267-2:2009EN 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 requirements

12、 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 resou

13、rces 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 devices

14、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 for

15、the control and assessment of design changes 16 Bibliography . 17 BS EN 15267-2:2009EN 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 the sta

16、tus 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 may be th

17、e 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, Air quali

18、ty 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 test p

19、rocedures 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, Czech Repub

20、lic, 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. BS EN 15267-2:2009EN 15267-2:2009 (E) 4 Introduction

21、 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 requirements.

22、 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 daughter directives

23、 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 AMS this Eur

24、opean 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 follows the

25、 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. BS EN 15267-2

26、:2009EN 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 performance of certif

27、ied 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 references, only the editi

28、on 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 certification of m

29、anagement 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 system AMS entir

30、ety 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 sample conditioni

31、ng (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 in Europe. The ter

32、ms “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 state, that carri

33、es 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, 3.3 BS EN 15267-

34、2:2009EN 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 or locations, that car

35、ries 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 “manufacturer“ is used instead of

36、 “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 European Standards EN

37、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 documents EN 15267-1:2008,

38、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 referenced in the test r

39、eport NOTE A related document can be used, for example, for the detailed manufacture of component parts. EN 15267-1:2008, 3.10 BS EN 15267-2:2009EN 15267-2:2009 (E) 7 3.12 certification range range over which the automated measuring system is tested and certified for compliance with the relevant per

40、formance 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 over the measurement range.

41、 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 management system to ensure that

42、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 quality management system sh

43、all 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 apply. The manufacturer sha

44、ll 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 specified in 4.2.2 of EN ISO 90

45、01:2000 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 performance of the AMS. BS EN 15

46、267-2:2009EN 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, instructions and computer code. The AM

47、S 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 simultaneous supplementary action in th

48、e 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

49、 retain, or have access to any legislation and CEN standards which contains performance criteria for AMS. 4.2.4 Control of records The requirements specified in 4.2.4 of EN ISO 9001:2000 apply. 5 Management responsibility 5.1 Management commitment The requirements specified in 5.1 of EN ISO 9001:2000 apply. The manufacturer shall make a commitment to know and understand the monitoring requirements and applicable performance criteria for AMS, and the impact of these requirements on instrument design,