Air quality - Certification of automated measuring systems - Part 1: General principles

This European Standard specifies the general principles, including common procedures and requirements, for the product certification of automated measuring systems (AMS) for monitoring ambient air quality and emissions from stationary sources. This product certification consists of the following sequential stages:
a)   performance testing of an automated measuring system;
b)   initial assessment of the AMS manufacturer’s quality management system;
c)   certification;
d)   surveillance.
This European Standard applies to the certification of all AMS for monitoring ambient air quality and emissions from stationary sources for which performance criteria and test procedures are available in European Standards.

Luftbeschaffenheit - Zertifizierung von automatischen Messeinrichtungen - Teil 1: Grundlagen

Diese Europäische Norm legt die Grundlagen einschließlich allgemeiner Verfahren und Anforderungen für die Produktzertifizierung von automatischen Messeinrichtungen (AMS) zur Überwachung von Emissionen aus stationären Quellen und von Immissionen fest. Diese Produktzertifizierung besteht aus den folgenden sequentiellen Stufen:  
a)   Eignungsprüfung einer automatischen Messeinrichtung;
b)   erstmalige Beurteilung des Qualitätsmanagementsystems des Herstellers der automatischen Messeinrichtung;
c)   Zertifizierung;
d)   Überwachung.
Diese Europäische Norm gilt für die Zertifizierung von allen automatischen Messeinrichtungen zur Überwachung von Immissionen und von Emissionen aus stationären Quellen, für die Mindestanforderungen und Prüfprozeduren in Europäischen Normen verfügbar sind.

Qualité de l'air - Certification des systèmes de mesurage automatisés - Partie 1 : Principes généraux

La présente Norme européenne spécifie les principes généraux, y compris les modes opératoires et les exigences communs, de la certification de produit des systèmes de mesurage automatisés (AMS) de contrôle de la qualité de l’air ambiant et des émissions de sources fixes. Cette certification de produit inclut les étapes séquentielles suivantes :
a)   les essais de performance d’un système de mesurage automatisé ;
b)   l’évaluation initiale du système de management de la qualité du fabriquant de l’AMS ;
c)   la certification ;
d)   la surveillance.
Le présente Norme européenne est applicable à la certification de tous les AMS de contrôle de l’air ambiant et des émissions de sources fixes dont les critères de performances et les modes opératoires d’essai sont mentionnés dans les Normes européennes en vigueur.

Kakovost zraka - Certificiranje avtomatskih merilnih sistemov (AMS) - 1. del: Splošna načela

General Information

Status
Published
Publication Date
17-Mar-2009
Current Stage
9093 - Decision to confirm - Review Enquiry

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SLOVENSKI STANDARD
SIST EN 15267-1:2009
01-oktober-2009
Kakovost zraka - Certificiranje avtomatskih merilnih sistemov (AMS) - 1. del:
Splošna načela

Air quality - Certification of automated measuring systems - Part 1: General principles

Luftbeschaffenheit - Zertifizierung von automatischen Messeinrichtungen - Teil 1:

Grundlagen

Qualité de l'air - Certification des systemes de mesurage automatisés - Partie 1 :

Principes généraux
Ta slovenski standard je istoveten z: EN 15267-1:2009
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
13.040.01 Kakovost zraka na splošno Air quality in general
SIST EN 15267-1:2009 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 15267-1:2009
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SIST EN 15267-1:2009
EUROPEAN STANDARD
EN 15267-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 13.040.99
English Version
Air quality - Certification of automated measuring systems - Part
1: General principles

Qualité de l'air - Certification des systèmes de mesurage Luftbeschaffenheit - Zertifizierung von automatischen

automatisés - Partie 1 : Principes généraux Messeinrichtungen - Teil 1: Grundlagen

This European Standard 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 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 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 Management Centre has the same status as the

official 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, 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

© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 15267-1:2009: E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 15267-1:2009
EN 15267-1:2009 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Introduction .........................................................................................................................................................4

1 Scope ......................................................................................................................................................5

2 Normative references ............................................................................................................................5

3 Terms and definitions ...........................................................................................................................6

4 Abbreviations .........................................................................................................................................7

5 Principles ................................................................................................................................................7

5.1 Performance testing of the automated measuring system ...............................................................7

5.2 Initial assessment of the AMS manufacturer's quality management system .................................8

5.3 Certification ............................................................................................................................................8

5.4 Surveillance ............................................................................................................................................8

6 Roles and responsibilities ....................................................................................................................9

6.1 General ....................................................................................................................................................9

6.2 Roles and responsibilities of the manufacturer .................................................................................9

6.3 Roles and responsibilities of the test laboratory ...............................................................................9

6.4 Roles and responsibilities of the relevant body .............................................................................. 10

7 Certification procedure ...................................................................................................................... 11

7.1 General ................................................................................................................................................. 11

7.2 Performance testing of the automated measuring system ............................................................ 11

7.3 Initial assessment of the manufacturer’s quality management system ....................................... 11

7.4 Certification ......................................................................................................................................... 11

7.5 Surveillance ......................................................................................................................................... 12

7.6 Review of certifications ...................................................................................................................... 13

Annex A (informative) Application and assessment processes ................................................................ 14

Annex B (informative) Example certificate template ................................................................................... 15

Bibliography ..................................................................................................................................................... 17

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SIST EN 15267-1:2009
EN 15267-1:2009 (E)
Foreword

This document (EN 15267-1:2009) 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 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 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 is Part 1 of a series of European Standards:

EN 15267-1, Air quality — Certification of automated measuring systems — Part 1: General principles

EN 15267-2, Air quality — Certification of automated measuring systems — Part 2: Initial assessment of the

AMS manufacturer’s 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 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, 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 the United Kingdom.
---------------------- Page: 5 ----------------------
SIST EN 15267-1:2009
EN 15267-1:2009 (E)
Introduction

The 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. 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 [4], [5], [6] and [7].

The responsibility for approving AMS for monitoring ambient air quality under Directive 96/62/EC lies with the

national competent authority or a body designated by the EU member state. No explicit requirement for

approving AMS for monitoring emissions from stationary sources is defined in the relevant EU Directives,

although the competent authorities in some EU member states have such arrangements in place.

In some EU member states the competent authority delegates the responsibility for approval of AMS to a

certification body accredited to EN 45011 by national accreditation bodies. In some EU member states the

competent authority cannot be accredited by external bodies, in others they may be. These approaches have

built up over many years and reflect the different administrative and legal arrangements that exist in the EU

member states. In order to recognize these different approaches, this European Standard uses the collective

term “relevant body” when referring to competent authority or certification body. The terms “competent

authority” and “certification body” are only used where it is necessary to be specific for the purpose of clarity in

the way in which a requirement applies under the different approaches.

The European Standard EN 45011 specifies general criteria that a certification body operating product

certification shall follow if it is to be recognized at a national or European level as competent and reliable in the

operation of a product certification system, irrespective of the sector involved. It is intended for the use of

accreditation bodies concerned with recognizing the competence of certification bodies. EN 45011 is identical

to ISO/IEC Guide 65. The document EA-6/01 [8] published by the International Accreditation Forum (IAF)

provides guidelines on the application of EN 45011. The purpose of EA-6/01 is to harmonise the worldwide

application of EN 45011 by accreditation bodies as an important step towards mutual recognition between

certification bodies under the IAF Multilateral Agreement (MLA).

EN 45011 recognizes that these general criteria may have to be supplemented when applied to a particular

sector. This European Standard provides guidance on the application of EN 45011 to the certification of AMS

for monitoring ambient air quality and emissions from stationary sources. It is Part 1 of a three part series of

European Standards, which specify common requirements for the certification of AMS in EU member states.

This European Standard defines common procedures and requirements for the certification of AMS to

facilitate mutual recognition by the relevant bodies and thereby minimise administrative and cost burdens on

AMS manufacturers seeking certification in multiple member states. It also describes the roles and

responsibilities of manufacturers, test laboratories, certification bodies (for quality management systems) and

relevant bodies under these procedures.
---------------------- Page: 6 ----------------------
SIST EN 15267-1:2009
EN 15267-1:2009 (E)
1 Scope

This European Standard specifies the general principles, including common procedures and requirements, for

the product certification of automated measuring systems (AMS) for monitoring ambient air quality and

emissions from stationary sources. This product certification consists of the following sequential stages:

a) performance testing of an automated measuring system;
b) initial assessment of the AMS manufacturer’s quality management system;
c) certification;
d) surveillance.

This European Standard applies to the certification of all AMS for monitoring ambient air quality and emissions

from stationary sources for which performance criteria and test procedures are available in European

Standards.
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 14211, Ambient air quality — Standard method for the measurement of the concentration of nitrogen

dioxide and nitrogen monoxide by chemiluminescence

EN 14212, Ambient air quality — Standard method for the measurement of the concentration of sulphur

dioxide by ultraviolet fluorescence

EN 14625, Ambient air quality — Standard method for the measurement of the concentration of ozone by

ultraviolet photometry

EN 14626, Ambient air quality — Standard method for the measurement of the concentration of carbon

monoxide by nondispersive infrared spectroscopy

EN 14662-3, Ambient air quality — Standard method for measurement of benzene concentrations — Part 3:

Automated pumped sampling with in situ gas chromatography

EN 15267-2, Air quality — Certification of automated measuring systems — Part 2: Initial assessment of the

AMS manufacturer’s 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 procedures for automated measuring systems for monitoring emissions from stationary sources

EN 45011, General requirements for bodies operating product certification systems (ISO/IEC Guide 65:1996)

EN ISO 9001, Quality management systems — Requirements (ISO 9001:2000)

EN ISO/IEC 17021, Conformity assessment — Requirements for bodies providing audit and certification 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)
---------------------- Page: 7 ----------------------
SIST EN 15267-1:2009
EN 15267-1:2009 (E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
automated measuring 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 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 in 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.
3.2
relevant body

competent authority or certification body, nominated by a competent authority or EU member state, that

carries out the certification of automated measuring systems
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
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
3.5
manufacturer

organisation, situated at a stated location 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 "manufacturer" is used instead of "organisation" as used in EN ISO 9001. For the purpose of this

document they are interchangeable.
3.6
test laboratory

laboratory accredited to EN ISO/IEC 17025 for carrying out the performance tests on automated measuring

systems in accordance with applicable European Standards
3.7
product
automated measuring system
3.8
technical file
record of the reference documents and design changes to the reference documents
3.9
reference document

document that controls the manufacture and design of an AMS and is referenced in the test report

---------------------- Page: 8 ----------------------
SIST EN 15267-1:2009
EN 15267-1:2009 (E)

NOTE Reference documents can include drawings, specifications, instructions and computer code.

3.10
related document
document not referenced in the test report

NOTE A related document can be used, for example, for the detailed manufacture of component parts.

3.11
certification range

range over which the automated measuring system is tested and certified for compliance 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 over the measurement range.
3.12
surveillance

systematic iteration of conformity assessment activities as a basis for maintaining the validity of the statement

of conformity
[EN ISO/IEC 17000:2004, 6.1]

NOTE For the purposes of this European Standard surveillance focuses on the manufacturer’s quality management

system to ensure that automated measuring systems continue to comply with the standard to which they are certified.

3.13
legislation
directives, acts, ordinances and regulations
4 Abbreviations
AMS automated measuring system
EA European Co-operation for Accreditation
EU European Union
IAF International Accreditation Forum
MLA Multilateral Agreement
QMS quality management system
5 Principles
5.1 Performance testing of the automated measuring system

Performance testing consists of a combination of laboratory and field testing. Laboratory testing is designed to

assess whether an automated measuring system (AMS) can meet, under controlled conditions, the

performance criteria specified for the relevant performance characteristics. Field testing, over a minimum

three month period, is designed to assess whether an AMS can continue to work and meet the relevant

performance criteria in a real application. For emissions monitoring, AMS field testing is carried out on an

industrial installation representative of the intended application for the AMS for which the manufacturer seeks

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SIST EN 15267-1:2009
EN 15267-1:2009 (E)

certification. For ambient air monitoring AMS field testing is carried out at sites as specified in the Framework

Directive on ambient air quality assessment and management [3] and the associated daughter directives [4],

[5], [6] and [7] as well as in the corresponding European Standards.

An AMS is tested to evaluate its performance against criteria specified in an applicable European Standard for

the performance and testing of AMS. The testing is carried out by a test laboratory accredited to EN

ISO/IEC 17025 with test procedures specified in the applicable Standard.
The applicable standards include:
 EN 15267-3 for AMS for monitoring emissions from stationary sources,

 EN 14211, EN 14212, EN 14625, EN 14626 and EN 14662-3 for AMS for monitoring ambient air quality,

and

 other European Standards currently under preparation that specify performance criteria and test

procedures for AMS for monitoring emissions from stationary sources or monitoring ambient air quality.

5.2 Initial assessmen
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Luftbeschaffenheit - Zertifizierung von automatischen Messeinrichtungen - Teil 1: GrundlagenQualité de l'air - Certification des systemes de mesurage automatisés - Partie 1 : Principes générauxAir quality - Certification of automated measuring systems - Part 1: General principles13.040.01Kakovost zraka na splošnoAir quality in generalICS:Ta slovenski standard je istoveten z:EN 15267-1:2009SIST EN 15267-1:2009en,fr,de01-oktober-2009SIST EN 15267-1:2009SLOVENSKI

STANDARD
SIST EN 15267-1:2009

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 15267-1March 2009ICS 13.040.99 English VersionAir quality - Certification of automated measuring systems - Part1: General principlesQualité de l'air - Certification des systèmes de mesurageautomatisés - Partie 1 : Principes générauxLuftbeschaffenheit - Zertifizierung von automatischenMesseinrichtungen - Teil 1: GrundlagenThis European Standard 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 such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:

Avenue Marnix 17,

B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 15267-1:2009: ESIST EN 15267-1:2009

EN 15267-1:2009 (E) 2 Contents Page Foreword ..............................................................................................................................................................3 Introduction .........................................................................................................................................................4 1 Scope ......................................................................................................................................................5 2 Normative references ............................................................................................................................5 3 Terms and definitions ...........................................................................................................................6 4 Abbreviations .........................................................................................................................................7 5 Principles ................................................................................................................................................7 5.1 Performance testing of the automated measuring system ...............................................................7 5.2 Initial assessment of the AMS manufacturer's quality management system .................................8 5.3 Certification ............................................................................................................................................8 5.4 Surveillance ............................................................................................................................................8 6 Roles and responsibilities ....................................................................................................................9 6.1 General ....................................................................................................................................................9 6.2 Roles and responsibilities of the manufacturer .................................................................................9 6.3 Roles and responsibilities of the test laboratory ...............................................................................9 6.4 Roles and responsibilities of the relevant body .............................................................................. 10 7 Certification procedure ...................................................................................................................... 11 7.1 General ................................................................................................................................................. 11 7.2 Performance testing of the automated measuring system ............................................................ 11 7.3 Initial assessment of the manufacturer’s quality management system ....................................... 11 7.4 Certification ......................................................................................................................................... 11 7.5 Surveillance ......................................................................................................................................... 12 7.6 Review of certifications ...................................................................................................................... 13 Annex A (informative)

Application and assessment processes ................................................................ 14 Annex B (informative)

Example certificate template ................................................................................... 15 Bibliography ..................................................................................................................................................... 17

SIST EN 15267-1:2009

EN 15267-1:2009 (E) 3 Foreword This document (EN 15267-1:2009) 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 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 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 is Part 1 of a series of European Standards: EN 15267-1, Air quality — Certification of automated measuring systems — Part 1: General principles EN 15267-2, Air quality — Certification of automated measuring systems — Part 2: Initial assessment of the AMS manufacturer’s 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 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, 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 the United Kingdom. SIST EN 15267-1:2009

EN 15267-1:2009 (E) 4 Introduction The 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. 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 [4], [5], [6] and [7]. The responsibility for approving AMS for monitoring ambient air quality under Directive 96/62/EC lies with the national competent authority or a body designated by the EU member state. No explicit requirement for approving AMS for monitoring emissions from stationary sources is defined in the relevant EU Directives, although the competent authorities in some EU member states have such arrangements in place.

In some EU member states the competent authority delegates the responsibility for approval of AMS to a certification body accredited to EN 45011 by national accreditation bodies. In some EU member states the competent authority cannot be accredited by external bodies, in others they may be. These approaches have built up over many years and reflect the different administrative and legal arrangements that exist in the EU member states. In order to recognize these different approaches, this European Standard uses the collective term “relevant body” when referring to competent authority or certification body. The terms “competent authority” and “certification body” are only used where it is necessary to be specific for the purpose of clarity in the way in which a requirement applies under the different approaches. The European Standard EN 45011 specifies general criteria that a certification body operating product certification shall follow if it is to be recognized at a national or European level as competent and reliable in the operation of a product certification system, irrespective of the sector involved. It is intended for the use of accreditation bodies concerned with recognizing the competence of certification bodies. EN 45011 is identical to ISO/IEC Guide 65. The document EA-6/01 [8] published by the International Accreditation Forum (IAF) provides guidelines on the application of EN 45011. The purpose of EA-6/01 is to harmonise the worldwide application of EN 45011 by accreditation bodies as an important step towards mutual recognition between certification bodies under the IAF Multilateral Agreement (MLA).

EN 45011 recognizes that these general criteria may have to be supplemented when applied to a particular sector. This European Standard provides guidance on the application of EN 45011 to the certification of AMS for monitoring ambient air quality and emissions from stationary sources. It is Part 1 of a three part series of European Standards, which specify common requirements for the certification of AMS in EU member states. This European Standard defines common procedures and requirements for the certification of AMS to facilitate mutual recognition by the relevant bodies and thereby minimise administrative and cost burdens on AMS manufacturers seeking certification in multiple member states. It also describes the roles and responsibilities of manufacturers, test laboratories, certification bodies (for quality management systems) and relevant bodies under these procedures. SIST EN 15267-1:2009

EN 15267-1:2009 (E) 5 1 Scope This European Standard specifies the general principles, including common procedures and requirements, for the product certification of automated measuring systems (AMS) for monitoring ambient air quality and emissions from stationary sources. This product certification consists of the following sequential stages: a) performance testing of an automated measuring system; b) initial assessment of the AMS manufacturer’s quality management system; c) certification; d) surveillance.

This European Standard applies to the certification of all AMS for monitoring ambient air quality and emissions from stationary sources for which performance criteria and test procedures are available in European Standards. 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 14211, Ambient air quality — Standard method for the measurement of the concentration of nitrogen dioxide and nitrogen monoxide by chemiluminescence EN 14212, Ambient air quality — Standard method for the measurement of the concentration of sulphur dioxide by ultraviolet fluorescence EN 14625, Ambient air quality — Standard method for the measurement of the concentration of ozone by ultraviolet photometry EN 14626, Ambient air quality — Standard method for the measurement of the concentration of carbon monoxide by nondispersive infrared spectroscopy EN 14662-3, Ambient air quality — Standard method for measurement of benzene concentrations — Part 3: Automated pumped sampling with in situ gas chromatography EN 15267-2, Air quality — Certification of automated measuring systems — Part 2: Initial assessment of the AMS manufacturer’s 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 procedures for automated measuring systems for monitoring emissions from stationary sources

EN 45011, General requirements for bodies operating product certification systems (ISO/IEC Guide 65:1996) EN ISO 9001, Quality management systems — Requirements (ISO 9001:2000)

EN ISO/IEC 17021, Conformity assessment — Requirements for bodies providing audit and certification 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) SIST EN 15267-1:2009

EN 15267-1:2009 (E) 6 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 automated measuring 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 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 in 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.

3.2 relevant body competent authority or certification body, nominated by a competent authority or EU member state, that carries out the certification of automated measuring systems

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 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

3.5 manufacturer organisation, situated at a stated location 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 "manufacturer" is used instead of "organisation" as used in EN ISO 9001. For the purpose of this document they are interchangeable. 3.6 test laboratory laboratory accredited to EN ISO/IEC 17025 for carrying out the performance tests on automated measuring systems in accordance with applicable European Standards

3.7 product
automated measuring system

3.8 technical file record of the reference documents and design changes to the reference documents 3.9 reference document document that controls the manufacture and design of an AMS and is referenced in the test report

SIST EN 15267-1:2009

EN 15267-1:2009 (E) 7 NOTE Reference documents can include drawings, specifications, instructions and computer code. 3.10 related document document not referenced in the test report

NOTE A related document can be used, for example, for the detailed manufacture of component parts. 3.11 certification range

range over which the automated measuring system is tested and certified for compliance 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 over the measurement range. 3.12 surveillance systematic iteration of conformity assessment activities as a basis for maintaining the validity of the statement of conformity

[EN ISO/IEC 17000:2004, 6.1] NOTE For the purposes of this European Standard surveillance focuses on the manufacturer’s quality management system to ensure that automated measuring systems continue to comply with the standard to which they are certified. 3.13 legislation directives, acts, ordinances and regulations 4 Abbreviations AMS automated measuring system EA European Co-operation for Accreditation EU European Union IAF International Accreditation Forum

MLA Multilateral Agreement

QMS quality management system 5 Principles 5.1 Performance testing of the automated measuring system

Performance testing consists of a combination of laboratory and field testing. Laboratory testing is designed to assess whether an automated measuring system (AMS) can meet, under controlled conditions, the performance criteria specified for the relevant performance characteristics. Field testing, over a minimum three month period, is designed to assess whether an AMS can continue to work and meet the relevant performance criteria in a real application. For emissions monitoring, AMS field testing is carried out on an industrial installation representative of the intended application for the AMS for which the manufacturer seeks SIST EN 15267-1:2009

EN 15267-1:2009 (E) 8 certification. For ambient air monitoring AMS field testing is carried out at sites as specified in the Framework Directive on ambient air quality assessment and management [3] and the associated daughter directives [4], [5], [6] and [7] as well as in the corresponding European Standards. An AMS is tested to evaluate its performance against criteria specified in an applicable European Standard for the performance and testing of AMS. The testing is carried out by a test laboratory accredited to EN ISO/IEC 17025 with test procedures specified in the applicable Standard. The applicable standards include:  EN 15267-3 for AMS for monitoring emissions from stationary sources,

 EN 14211, EN 14212, EN 14625, EN 14626 and EN 14662-3 for AMS for monitoring ambient air quality, and  other European Standards currently under preparation that specify performance criteria and test procedures for AMS for monitoring emissions from stationary sources or monitoring ambient air quality. 5.2 Initial assessment of the AMS manufacturer's quality management system An AMS typically under

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