SIST EN 15267-2:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Luftbeschaffenheit - Zertifizierung von automatischen Messeinrichtungen - Teil 2: Erstmalige Beurteilung des Qualitätsmanagementsystems des Herstellers und Überwachung des Herstellungsprozesses nach der ZertifizierungQualité de l'air - Certification des systemes de mesurage automatisés - Partie 2 : Evaluation initiale du systeme de gestion de la qualité des fabricants d'AMS et surveillance apres certification du procédé de fabricationAir 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 process13.040.01Kakovost zraka na splošnoAir quality in generalICS:Ta slovenski standard je istoveten z:EN 15267-2:2009SIST EN 15267-2:2009en,fr,de01-oktober-2009SIST EN 15267-2:2009SLOVENSKI
STANDARD



SIST EN 15267-2:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 15267-2March 2009ICS 13.040.99 English VersionAir quality - Certification of automated measuring systems - Part2: Initial assessment of the AMS manufacturer's qualitymanagement system and post certification surveillance for themanufacturing processQualité de l'air - Certification des systèmes de mesurageautomatisés - Partie 2 : Evaluation initiale du système degestion de la qualité des fabricants d'AMS et surveillanceaprès certification du procédé de fabricationLuftbeschaffenheit - Zertifizierung von automatischenMesseinrichtungen - Teil 2: Erstmalige Beurteilung desQualitätsmanagementsystems des Herstellers undÜberwachung des Herstellungsprozesses nach derZertifizierungThis 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 15267-2:2009: ESIST EN 15267-2:2009



EN 15267-2:2009 (E) 2 Contents Page Foreword .3 Introduction .4 1 Scope .5 2 Normative references .5 3 Terms and definitions .5 4 Quality management systems .7 4.1 General requirements .7 4.2 Documentation requirements .7 5 Management responsibility .8 5.1 Management commitment .8 5.2 Customer focus .8 5.3 Quality policy .8 5.4 Planning .8 5.5 Responsibility, authority and communication .9 5.6 Management review .9 6 Resource management . 10 6.1 Provision of resources . 10 6.2 Human resources. 10 6.3 Infrastructure . 10 6.4 Work environment . 10 7 Product realisation . 10 7.1 Planning of product realisation . 10 7.2 Customer-related processes . 10 7.3 Design and development . 11 7.4 Purchasing . 12 7.5 Production and service provision . 13 7.6 Control of monitoring and measuring devices . 13 8 Measurement, analysis and improvement . 13 8.1 General . 13 8.2 Monitoring and measurement . 13 8.3 Control of non-conforming product . 14 8.4 Analysis of data . 14 8.5 Improvement . 14 9 Assessment . 15 9.1 Initial assessment . 15 9.2 Continuing surveillance . 15 Annex A (informative)
Process for the control and assessment of design changes . 16 Bibliography . 17
SIST EN 15267-2:2009



EN 15267-2:2009 (E) 3 Foreword This document (EN 15267-2:2009) has been prepared by Technical Committee CEN/TC 264 “Air quality”, the secretariat of which is held by DIN. This European Standard shall be given 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 2 of a series of European Standards: EN 15267-1, Air quality — Certification of automated measuring systems — Part 1: General principles EN 15267-2, Air 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 15267-2:2009



EN 15267-2:2009 (E) 4 Introduction The product certification of automated measuring systems (AMS) supports the requirements of certain Directives of the European Union (EU), which require, either directly or indirectly, that AMS comply with performance criteria, maximum permissible measurement uncertainties and testing 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]. An AMS will typically undergo design changes during its product life. It is essential to ensure that such changes do not alter the AMS such that it no longer conforms with its certified performance. In order to control such design changes for the product certification of AMS this European Standard specifies the requirements for  the manufacturer’s quality management system,  the initial assessment of an AMS manufacturer’s production control, and  the continuing surveillance of the effect on performance of certified AMS of subsequent design changes. This European Standard follows the structure of EN ISO 9001:2000 such that clause numbers in Clauses 4 to 8 of this standard coincide with those of EN ISO 9001:2000. However, this European Standard does not preclude the use of other quality management systems that are compatible with the objectives of EN ISO 9001:2000.
SIST EN 15267-2:2009



EN 15267-2:2009 (E) 5 1 Scope This European Standard specifies the requirements for the manufacturer’s quality management system, the initial assessment of the manufacturer’s production control and the continuing surveillance of the effect of subsequent design changes on the performance of certified automated measuring systems.
This European Standard also serves as a reference document for auditing the manufacturer’s quality management system. 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 ISO 9001:2000, 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) 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.
[EN 15267-1:2008, 3.1] 3.2 relevant body competent authority or certification body, nominated by a competent authority or EU member state, that carries out the certification of automated measuring systems
[EN 15267-1:2008, 3.2] 3.3 competent authority organisation which implements the requirements of EU Directives and regulates installations, which must comply with the requirements of applicable European Standards [EN 15267-1:2008, 3.3] SIST EN 15267-2:2009



EN 15267-2:2009 (E) 6 3.4 certification body any body operating a product certification system or any body accredited to EN ISO/IEC 17021 for the certification of quality management systems
[EN 15267-1:2008, 3.4] 3.5 manufacturer organisation, situated at a stated location 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. [EN 15267-1:2008, 3.5] 3.6 test laboratory laboratory accredited to EN ISO/IEC 17025 for carrying out performance tests on automated measuring systems in accordance with applicable European Standards [EN 15267-1:2008, 3.6] 3.7 product
automated measuring system
[EN 15267-1:2008, 3.7] 3.8 technical documentation information for the operation of automated measuring systems, such as manuals 3.9 technical file record of the reference documents and design changes to the reference documents [EN 15267-1:2008, 3.8] 3.10 reference document document that controls the manufacture and design of an AMS and is referenced in the test report
NOTE Reference documents can include drawings, specifications, instructions and computer code.
[EN 15267-1:2008, 3.9] 3.11 related document document not referenced in the test report NOTE A related document can be used, for example, for the detailed manufacture of component parts. [EN 15267-1:2008, 3.10] SIST EN 15267-2:2009



EN 15267-2:2009 (E) 7 3.12 certification range
range over which the automated measuring system is tested and certified for compliance with the relevant 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. [EN 15267-1:2008, 3.11] 3.13 surveillance systematic iteration of conformity assessment activities as a basis for maintaining the validity of the statement of conformity
NOTE For the purposes of this European Standard surveillance focuses on the manufacturer’s quality management system to ensure that automated measuring systems continue to comply with the standard to which they are certified. [EN 15267-1:2008, 3.12] 3.14 legislation directives, acts, ordinances and regulations [EN 15267-1:2008, 3.13] 4 Quality management systems 4.1 General requirements
The manufacturer’s quality management system shall ensure compliance of all automated measuring systems, of the type that has been product certified, with the performance criteria specified in the relevant certificate. 4.2 Documentation requirements 4.2.1 General The requirements specified in 4.2.1 of EN ISO 9001:2000 apply.
The manufacturer shall have methods to keep up-to-date with the requirements of legislation, standards and guidelines that are relevant to its c
...

SLOVENSKI STANDARD
oSIST prEN 15267-2:2007
01-julij-2007
.DNRYRVW]UDND&HUWLILFLUDQMHDYWRPDWVNLKPHULOQLKVLVWHPRY$06GHO
=DþHWQRRFHQMHYDQMHSURL]YDMDOþHYLKVLVWHPRYNDNRYRVWL]D$06LQQDG]RUQDG
SURL]YDMDOþHYLPLSURFHVLSRFHUWLILFLUDQMX
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
Luftbeschaffenheit - Zertifizierung von automatischen Messeinrichtungen - Teil 2:
Erstmalige Beurteilung des Qualitätsmanagementsystems des Herstellers und
Überwachung des Herstellungsprozesses nach der Zertifizierung
Qualité de l'air - Certification des systemes de mesurage automatisés - Partie 2 :
Evaluation initiale du systeme de gestion de la qualité des fabricants d'AMS et
surveillance apres certification du procédé de fabrication
Ta slovenski standard je istoveten z: prEN 15267-2
ICS:
13.040.99 Drugi standardi v zvezi s Other standards related to air
kakovostjo zraka quality
oSIST prEN 15267-2:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
DRAFT
prEN 15267-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2007
ICS 13.040.99

English Version
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
Qualité de l'air - Certification des systèmes de mesurage
automatisés - Partie 2 : Evaluation initiale du système de
gestion de la qualité des fabricants d'AMS et surveillance
après certification du procédé de fabrication
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 15267-2:2007: E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------
prEN 15267-2:2007 (E)
Contents Page
Foreword.3
Introduction .3
1 Scope .4
2 Normative references .4
3 Terms and definitions .4
4 Quality management systems.5
4.1 General requirements.5
4.2 Documentation requirements.5
5 Management responsibility .6
5.1 Management commitment .6
5.2 Customer focus.6
5.3 Quality policy .6
5.4 Planning.6
5.5 Responsibility, authority and communication.7
5.6 Management review.7
6 Resource management .7
6.1 Provision of resources.7
6.2 Human resources.8
6.3 Infrastructure.8
6.4 Work environment .8
7 Product realisation .8
7.1 Planning of AMS realisation .8
7.2 Customer-related processes .8
7.3 Design and development .8
7.4 Purchasing .9
7.5 Production and service provision.11
7.6 Control of monitoring and measuring devices.11
8 Measurement, analysis and improvement .11
8.1 General.11
8.2 Monitoring and measurement .11
8.3 Control of non-conforming product.12
8.4 Analysis of data .12
8.5 Improvement .12
9 Assessment.12
9.1 Initial assessment.12
9.2 Continuing surveillance .13
Annex A (informative) Process for the control and assessment of design changes.14
Bibliography .15

2

---------------------- Page: 3 ----------------------
prEN 15267-2:2007 (E)
Foreword
This document (prEN 15267-2:2007) 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 2 of a series of European Standards:
 EN 15267-1, Air quality – Certification of automated measuring systems – Part 1: General principles
 EN 15267-2, Air 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 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].
This standard defines the requirements for:
 the manufacturer’s quality management system;
 the initial assessment of an AMS manufacturer’s production control;
 the continuing surveillance of the effect on performance of certified AMS of subsequent design changes.
The clauses of this standard supplement those of EN ISO 9001:2000. The additional requirements to
EN ISO 9001:2000 cover specific provisions that apply to the control of design and manufacturing of AMS.
AMS typically undergo design changes during their design lives and it is essential to ensure that such
changes do not change the performance of the AMS such that it no longer meets the required performance
criteria.
3

---------------------- Page: 4 ----------------------
prEN 15267-2:2007 (E)
1 Scope
This European Standard covers the supplementary requirements for an AMS manufacturer’s management
system to EN ISO 9001:2000, for the control of design and manufacturing of AMS. This European Standard
also serves as a reference document for auditing the AMS manufacturer’s management system.
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 ISO 9001:2000, Quality management systems – Requirements.
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 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 regulate 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.
4

---------------------- Page: 5 ----------------------
prEN 15267-2:2007 (E)
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 test report
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
legislation
directives, acts, ordinances and regulations
4 Quality management systems
4.1 General requirements
The manufacturer’s quality management system shall meet the requirements of EN ISO 9001:2000 and the
supplementary requirements described in this European Standard.
NOTE The clause numbers in this standard coincide with those of EN ISO 9001:2000.
4.2 Documentation requirements
4.2.1 General
The manufacturer shall have methods to both access and keep up-to-date with the requirements of relevant
international legislation, international standards and guidelines, which include performance criteria for AMS.
5

---------------------- Page: 6 ----------------------
prEN 15267-2:2007 (E)
4.2.2 Management system manual
The quality management system shall ensure that no factor (e.g. measured components, scope) defined
within the AMS certificate and technical documentation (e.g. reference drawings) is modified without
appropriate evaluation of its impact on the performance of the AMS.
4.2.3 Control of documents
The AMS manufacturer shall have a method to refer to all related drawings to the relevant reference drawings
for the AMS.
Where there are common reference drawings associated with more than one AMS certificate, the
manufacturer shall have methods to ensure simultaneous supplementary action in the event of an amendment
to such drawings.
Where a manufacturer also has drawings for AMS not intended for testing and certification, then the
manufacturer shall have a method that enables both the related drawings and refer
...