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

RELATIONS

Buy Standard

Standard
EN 15267-2:2009
English language
17 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day
Standard
EN 15267-2:2009
English language
17 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN 15267-2:2009
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
SIST EN 15267-2:2009 en,fr,de

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

---------------------- Page: 1 ----------------------
SIST EN 15267-2:2009
---------------------- Page: 2 ----------------------
SIST EN 15267-2:2009
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.
---------------------- Page: 3 ----------------------
SIST EN 15267-2:2009
EN 15267-2:2009 (E)
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

---------------------- Page: 4 ----------------------
SIST EN 15267-2:2009
EN 15267-2:2009 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN 15267-2:2009
EN 15267-2:2009 (E)
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.
---------------------- Page: 6 ----------------------
SIST EN 15267-2:2009
EN 15267-2:2009 (E)
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]
---------------------- Page: 7 ----------------------
SIST EN 15267-2:2009
EN 15267-2:2009 (E)
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]
---------------------- Page: 8 ----------------------
SIST EN 15267-2:2009
EN 15267-2:2009 (E)
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 leg

...

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

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.