EN 15267-2:2009

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

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.

Luftbeschaffenheit - Zertifizierung von automatischen Messeinrichtungen - Teil 2: Erstmalige Beurteilung des Qualitätsmanagementsystems des Herstellers und Überwachung des Herstellungsprozesses nach der Zertifizierung

Diese Europäische Norm legt die Anforderungen an das Qualitätsmanagementsystem des Herstellers, die erstmalige Beurteilung der Produktionslenkung des Herstellers und die fortgesetzte Überwachung von Einflüssen auf die Leistungsfähigkeit zertifizierter automatischer Messeinrichtungen, die durch spätere bauliche Änderungen hervorgerufen werden.
Diese Europäische Norm dient auch als Bezugsdokument für die Auditierung des Qualitätsmanagementsystems des Herstellers.

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

La présente Norme européenne spécifie les exigences relatives au système de management de la qualité du
fabricant, l’évaluation initiale du contrôle de la production du fabricant et la surveillance continue de l’impact
qu’ont pu avoir des modifications ultérieures de conception sur les performances des systèmes de mesurage
automatisés certifiés.
La présente Norme européenne sert également de document de référence pour l’audit du système de
management de la qualité du fabricant.

Kakovost zraka - Certificiranje avtomatskih merilnih sistemov (AMS) - 2. del: Začetno ocenjevanje proizvajalčevih sistemov kakovosti za AMS in nadzor nad proizvajalčevimi procesi proizvodnje po certificiranju

General Information

• Status: Withdrawn
• Publication Date: 17-Mar-2009
• Withdrawal Date: 04-Jul-2023
• ICS: 03.100.70 - Management systems
• ICS: 13.040.99 - Other standards related to air quality
• Technical Committee: CEN/TC 264 - Air quality
• Drafting Committee: CEN/TC 264/WG 22 - Certification scheme for AMS
• Directive: 2000/69/EC - Directive 2000/69/EC of the European Parliament and of the Council of 16 November 2000 relating to limit values for benzene and carbon monoxide in ambient air. Benzene, CO-2nd Daughter Directive
• Directive: 2000/76/EC - Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste
• Directive: 2001/80/EC - Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants
• Directive: 2002/3/EC - Ozone - 3rd Daughter Directive
• Directive: 96/62/EC - Ambient air quality assessment and management
• Ref Project: SIST EN 15267-2:2009 - 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

Relations

• Replaced By: EN 15267-2:2023 - Air quality - Assessment of air quality monitoring equipment - Part 2: Initial assessment of the manufacturer’s quality management system and post certification surveillance for the manufacturing process
• Effective Date: 28-Jan-2023

Standards Content (Sample)

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
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

Process for the control and assessment of design changes . 16 Bibliography . 17
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.
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 15267-1:2008, 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 obli
...

SLOVENSKI STANDARD
01-oktober-2009
Kakovost zraka - Certificiranje avtomatskih merilnih sistemov (AMS) - 2. del:
Začetno ocenjevanje proizvajalčevih sistemov kakovosti za AMS in nadzor nad
proizvajalčevimi procesi proizvodnje po certificiranju
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: EN 15267-2:2009
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 15267-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
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 Luftbeschaffenheit - Zertifizierung von automatischen
automatisés - Partie 2 : Evaluation initiale du système de Messeinrichtungen - Teil 2: Erstmalige Beurteilung des
gestion de la qualité des fabricants d'AMS et surveillance Qualitätsmanagementsystems des Herstellers und
après certification du procédé de fabrication Überwachung des Herstellungsprozesses nach der
Zertifizierung
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 15267-2:2009: E
worldwide for CEN national Members.

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

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.

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.
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 a
...