SIST EN 15267-1:2009
(Main)Air quality - Certification of automated measuring systems - Part 1: General principles
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 der Produktzertifizierung von automatischen Messeinrichtungen (AMS) zur Überwachung von Emissionen aus stationären Quellen und von Immissionen fest. Diese Produktzertifizierung besteht aus den folgenden sequenziellen Stufen:
a) Eignungsprüfung einer AMS;
b) erstmalige Beurteilung des Qualitätsmanagementsystems des Herstellers der AMS;
c) Zertifizierung;
d) Produktüberwachung nach der Zertifizierung.
Qualité de l'air - Certification des systemes 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
Relations
Buy Standard
Standards Content (Sample)
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
---------------------- Page: 2 ----------------------
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
2
---------------------- Page: 4 ----------------------
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.
3
---------------------- 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.
4
---------------------- 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)
5
---------------------- 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
6
---------------------- 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
7
---------------------- Page: 9 ----------------------
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
...
SLOVENSKI STANDARD
oSIST prEN 15267-1:2007
01-julij-2007
.DNRYRVW]UDND&HUWLILFLUDQMHDYWRPDWVNLKPHULOQLKVLVWHPRY $06 GHO
6SORãQDQDþHOD
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: prEN 15267-1
ICS:
13.040.99 Drugi standardi v zvezi s Other standards related to air
kakovostjo zraka quality
oSIST prEN 15267-1:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
DRAFT
prEN 15267-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2007
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
automatisés - Partie 1 : Principes généraux
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 264.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 15267-1:2007: E
worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
prEN 15267-1:2007 (E)
Contents Page
Foreword.3
Introduction .3
1 Scope .4
2 Normative references .4
3 Terms and definitions .4
4 Abbreviations.6
5 Principles.6
5.1 Performance testing of the AMS .6
5.2 Initial assessment of the AMS manufacturer's quality management system .7
5.3 Certification .7
5.4 Post certification product surveillance .7
6 Roles and responsibilities .7
6.1 General.7
6.2 Roles and responsibilities of the manufacturer .8
6.3 Roles and responsibilities of the test laboratory .8
6.4 Roles and responsibilities of the certification body .9
6.5 Roles and responsibilities of the relevant body.9
7 Certification procedure .10
7.1 General.10
7.2 Performance testing of the AMS .10
7.3 Initial assessment of the manufacturer’s quality management system .10
7.4 Certification .10
7.5 Post-certification surveillance of the quality management system .11
7.6 Review of certifications.11
Annex A (informative) Application and assessment processes.12
Annex B (informative) Example certificate template.13
Bibliography .15
2
---------------------- Page: 3 ----------------------
prEN 15267-1:2007 (E)
Foreword
This document (prEN 15267-1:2007) has been prepared by Technical Committee CEN/TC 264 “Air quality”,
the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
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
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 15267-4, Air quality – Certification of automated measuring systems – Part 4: Performance
specifications and test procedures for automated measuring systems for monitoring ambient air quality
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].
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 45011:1998 [7] 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 45011:1998 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 45011:1998 is
identical to ISO/IEC Guide 65:1996. The document EA-6/01 [8] published by the International Accreditation
3
---------------------- Page: 4 ----------------------
prEN 15267-1:2007 (E)
Forum (IAF) provides guidelines on the application of EN 45011:1998. The purpose of EA-6/01 is to
harmonise the worldwide application of EN 45011:1998 by accreditation bodies as an important step towards
mutual recognition between certification bodies under the IAF Multilateral Agreement (MLA).
EN 45011:1998 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 45011:1998 to the
certification of AMS for monitoring ambient air quality and emissions from stationary sources. It is Part 1 of a
four 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.
1 Scope
This European Standard specifies the general principles of the product certification of automated measuring
systems (AMS) for monitoring emissions from stationary sources and ambient air quality. This product
certification consists of the following sequential stages:
a) performance testing of an AMS;
b) initial assessment of the AMS manufacturer’s quality management system;
c) certification;
d) post-certification product-surveillance.
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.
prEN 15267-2, Air Quality – Certification of automated measuring systems – Part 2: Initial assessment of the
manufacturer’s quality management system and post certification surveillance for the manufacturing process.
prEN 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.
prEN 15267-4, Air Quality – Certification of automated measuring systems – Part 4: Performance
specifications and test procedures for automated measuring systems for monitoring ambient air quality.
EN ISO 9001:2000, Quality management systems – Requirements.
EN ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
4
---------------------- Page: 5 ----------------------
prEN 15267-1:2007 (E)
3.1
automated measuring system
AMS
entirety of all measuring instruments and additional devices for obtaining a measurement result
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 AMS
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
accredited body qualified to EN ISO/IEC 17021 for the certification of quality management systems and/or
EN 45011 for the certification of products
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 its certification and undertakes all obligations in that connection
NOTE The term manufacturer is used instead of organisation as used in EN ISO 9001:2000. For the purpose of this
standard they are interchangeable.
3.6
test laboratory
laboratory accredited to EN ISO/IEC 17025 for carrying out performance tests
3.7
product
AMS or components, which form the AMS
NOTE In the context of this European Standard product means AMS.
3.8
technical documentation
information for the operation of AMS, such as manuals
3.9
technical file
record of the reference drawings and design changes to the reference drawings
3.10
reference drawing
drawing referenced in the testing report
5
---------------------- Page: 6 ----------------------
prEN 15267-1:2007 (E)
3.11
related drawing
drawing not referenced in the testing report
NOTE A related drawing could be used, for example, for the detailed manufacture of component parts.
3.12
certification range
range over which the AMS 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.
3.13
product surveillance
evaluation to determine the continued conformity of the certified product with specified requirements
[ISO/IEC Guide 2]
3.14
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
5 Principles
5.1 Performance testing of the AMS
Performance testing consists of a combination of laboratory and field testing. Laboratory testing is designed to
assess whether an 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 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].
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.
6
---------------------- Page: 7 ----------------------
prEN 15267-1:2007 (E)
The applicable standard for AMS for monitoring emissions from stationary sources is prEN 15267-3, and the
applicable standard for AMS for monitoring ambient air is prEN 15267-4. These two standards contain
performance criteria and test procedures for AMS.
5.2 Initial assessment of the AMS manufacturer's quality management system
An AMS typically undergoes design changes during its production life and it is essential to ensure that after
such changes, the AMS still meets the required performance criteria. Therefore, in order to meet these
performance criteria the manufacturer controls the quality assurance of production and design of the AMS
using a quality management system, which meets the requirements of EN ISO 9001:2000 and the
supplementary requirements specified in prEN 15267-2.
NOTE One means of demonstrating the compliance with EN ISO 9001:2000 and the requirements of prEN 15267-2
is through an initial and subsequent assessments of the manufacturer’s quality management system, as carried out by a
certification body accredited to EN ISO/IEC 17021.
5.3 Certification
The reports from the testing of the AMS and evidence of compliance with EN ISO 9001:2000 and prEN
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.