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

This document specifies the requirements for the manufacturer’s quality management system (QMS), the initial assessment of the manufacturer’s production control and the continuing surveillance of the effect of subsequent changes on the performance of certified air quality monitoring equipment (AQME).
This document also serves as a reference document for auditing the manufacturer’s QMS.
This document elaborates and supplements the requirements of EN ISO 9001:2015.

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

Dieses Dokument legt die Anforderungen an das Qualitätsmanagementsystem (QMS) des Herstellers, die Erstbeurteilung der Fertigungskontrolle des Herstellers und die fortlaufende Überwachung der Auswirkungen von nachträglichen Änderungen auf die Leistung von zertifizierten Einrichtungen zur Überwachung der Luftbeschaffenheit (AQME) fest.
Dieses Dokument dient auch als Referenzdokument für die Auditierung des QMS des Herstellers.
Dieses Dokument erläutert und ergänzt die Anforderungen der EN ISO 9001:2015.

Qualité de l’air - Évaluation des équipements de surveillance de la qualité de l’air - Partie 2 : Évaluation initiale du système de management de la qualité du fabricant et surveillance après certification du procédé de fabrication

Le présent document spécifie les exigences relatives au système de management de la qualité (SMQ) du fabricant, à l’évaluation initiale de la maîtrise de la production du fabricant et à la surveillance continue de l’impact des modifications ultérieures sur les performances des équipements de surveillance de la qualité de l’air (AQME) certifiés.
Le présent document sert également de document de référence pour l’audit du SMQ du fabricant.
Le présent document précise et complète les exigences de l’EN ISO 9001:2015.

Kakovost zraka - Ocenjevanje opreme za monitoring kakovosti zraka - 2. del: Začetno ocenjevanje proizvajalčevih sistemov kakovosti in nadzor nad proizvajalčevimi procesi proizvodnje po certificiranju

General Information

Status
Not Published
Current Stage
4060 - Closure of enquiry - Enquiry
Due Date
05-Mar-2022
Completion Date
05-Mar-2022

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SLOVENSKI STANDARD
oSIST prEN 15267-2:2021
01-december-2021
Kakovost zraka - Ocenjevanje opreme za monitoring kakovosti zraka - 2. del:
Začetno ocenjevanje proizvajalčevih sistemov kakovosti in nadzor nad
proizvajalčevimi procesi proizvodnje po certificiranju

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
Luftbeschaffenheit - Beurteilung von Einrichtungen zur Überwachung der

Luftbeschaffenheit - Teil 2: Erstmalige Beurteilung des Qualitätsmanagementsystems

des Herstellers und Überwachung des Herstellungsprozesses nach der Zertifizierung

Ta slovenski standard je istoveten z: prEN 15267-2
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
13.040.99 Drugi standardi v zvezi s Other standards related to air
kakovostjo zraka quality
oSIST prEN 15267-2:2021 en,fr,de

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

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oSIST prEN 15267-2:2021
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oSIST prEN 15267-2:2021
DRAFT
EUROPEAN STANDARD
prEN 15267-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2021
ICS 03.100.70; 13.040.99 Will supersede EN 15267-2:2009
English Version
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
Luftbeschaffenheit - Beurteilung von Einrichtungen zur
Überwachung der Luftbeschaffenheit - Teil 2:
Erstmalige Beurteilung des
Qualitätsmanagementsystems des Herstellers und
Überwachung des Herstellungsprozesses nach der
Zertifizierung

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-CENELEC

Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey 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
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 15267-2:2021 E

worldwide for CEN national Members.
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oSIST prEN 15267-2:2021
prEN 15267-2:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

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

4 Context of the organization ......................................................................................................................... 9

4.1 Understanding the organization and its context ................................................................................. 9

4.2 Understanding the needs and expectations of interested parties ................................................ 9

4.3 Determining the scope of the quality management system............................................................. 9

4.4 Quality management system and its processes.................................................................................... 9

5 Leadership ......................................................................................................................................................... 9

5.1 Leadership and commitment ...................................................................................................................... 9

5.1.1 General ................................................................................................................................................................ 9

5.1.2 Customer focus ................................................................................................................................................. 9

5.2 Policy ................................................................................................................................................................... 9

5.3 Organization roles, responsibilities and authorities ......................................................................... 9

6 Planning ........................................................................................................................................................... 10

7 Support ............................................................................................................................................................ 10

7.1 Resources ........................................................................................................................................................ 10

7.2 Competence .................................................................................................................................................... 10

7.3 Awareness ....................................................................................................................................................... 10

7.4 Communication ............................................................................................................................................. 10

7.5 Documented information .......................................................................................................................... 10

7.5.1 General ............................................................................................................................................................. 10

7.5.2 Creating and updating ................................................................................................................................ 10

7.5.3 Control of documented information ..................................................................................................... 11

8 Operation ........................................................................................................................................................ 11

8.1 Operational planning and control .......................................................................................................... 11

8.2 Requirements for products and services ............................................................................................ 11

8.2.1 Customer communication ......................................................................................................................... 11

8.2.2 Determining the requirements for products and services ........................................................... 11

8.2.3 Review of requirements for products and services ......................................................................... 11

8.2.4 Changes to requirements for products and services ....................................................................... 12

8.3 Design and development of products and services ......................................................................... 12

8.3.1 General ............................................................................................................................................................. 12

8.3.2 Design and development planning ........................................................................................................ 12

8.3.3 Design and development inputs ............................................................................................................. 12

8.3.4 Design and development controls ......................................................................................................... 12

8.3.5 Design and development outputs ........................................................................................................... 12

8.3.6 Design and development changes .......................................................................................................... 12

8.4 Control of external provision of goods and services ....................................................................... 13

8.4.1 General ............................................................................................................................................................. 13

8.4.2 Type and extent of control of external provision ............................................................................. 14

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prEN 15267-2:2021 (E)

8.4.3 Documented information for external providers ............................................................................. 14

8.5 Production and service provision .......................................................................................................... 14

8.5.1 Control of production and service provision ...................................................................................... 14

8.5.2 Identification and traceability ................................................................................................................. 14

8.5.3 Property belonging to customers or external providers ............................................................... 15

8.5.4 Preservation ................................................................................................................................................... 15

8.5.5 Post-delivery activities ............................................................................................................................... 15

8.5.6 Control of changes ........................................................................................................................................ 15

8.6 Release of products and services ............................................................................................................ 15

8.7 Control of non-conforming outputs ....................................................................................................... 15

9 Performance evaluation ............................................................................................................................. 15

9.1 Monitoring, measurement, analysis and evaluation ....................................................................... 15

9.1.1 General ............................................................................................................................................................. 15

9.1.2 Customer satisfaction .................................................................................................................................. 15

9.1.3 Analysis and evaluation ............................................................................................................................. 16

9.2 Internal audit ................................................................................................................................................. 16

9.3 Management review .................................................................................................................................... 16

9.3.1 General ............................................................................................................................................................. 16

9.3.2 Management review inputs ....................................................................................................................... 16

9.3.3 Management review outputs .................................................................................................................... 16

10 Improvement .................................................................................................................................................. 16

11 Assessment...................................................................................................................................................... 16

11.1 Initial assessment ......................................................................................................................................... 16

11.2 Continuing surveillance ............................................................................................................................. 16

Annex A (informative) Process for the control and assessment of changes ......................................... 17

Bibliography ................................................................................................................................................................. 18

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oSIST prEN 15267-2:2021
prEN 15267-2:2021 (E)
European foreword

This document (prEN 15267-2:2021) 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 will supersede EN 15267-2:2009.
The main changes with respect to the previous edition are listed below:

a) The title of the revised EN 15267 series has been clarified to avoid the impression that all parts deal

with the certification of automated measuring systems. The title has been generalized so that

specifically Part 1 and Part 2 are also applicable to other air quality monitoring equipment.

b) The title of revised EN 15267-2 has been clarified to make it clear that Part 2 deals only with the

manufacturing process as part of the certification of air quality monitoring equipment.

c) The revised EN 15267-2 is based on EN ISO 9001:2015 and is identically structured. It provides

guidance on the application of EN ISO 9001:2015 with respect to AQME. It supplements

EN ISO 9001:2015 by providing clarification and additional information. However, it does not re-

state all the provisions of EN ISO 9001:2015 and users are reminded of the need to comply with all

of the relevant criteria detailed in EN ISO 9001:2015.

d) The basic contents of EN 15267-2:2009 were largely adopted, updated and inserted into the

structure of EN ISO 9001:2015.

e) The term “competent body” has been deleted and replaced throughout the text by the term

“certification body”.
This document is Part 2 of a series of European Standards:

— EN 15267-1, Air quality — Assessment of air quality monitoring equipment — Part 1: General

principles of certification

— EN 15267-2, 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

— EN 15267-3, Air quality — Assessment of air quality monitoring equipment — Part 3: Performance

criteria and test procedures for stationary automated measuring systems for continuous monitoring of

emissions from stationary sources

— EN 15267-4, Air quality — Assessment of air quality monitoring equipment — Part 4: Performance

criteria and test procedures for portable automated measuring systems for periodic measurements of

emissions from stationary sources
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oSIST prEN 15267-2:2021
prEN 15267-2:2021 (E)
Introduction

The assessment of air quality monitoring equipment (AQME) supports the requirements of certain

Directives of the European Union (EU), which require, either directly or indirectly, that this equipment

comply with performance criteria, maximum permissible measurement uncertainties and testing

requirements. These Directives include the Directive 2010/75/EU on industrial emissions (IED),

Directive (EU) 2015/2193 on medium combustion plants and the Directive 2008/50/EC on ambient air

quality and cleaner air for Europe.
The assessment of AQME consists of the following sequential stages:
a) performance test;
b) initial assessment of the manufacturer’s quality management system (QMS);
c) certification;
d) surveillance for the manufacturing process.

AQME typically undergo changes during its product life. It is essential to ensure that such changes do not

alter the AQME such that they no longer conform with the certified performance. In order to control such

changes of AQME this document specifies the requirements for
— the manufacturer’s QMS,
— the initial assessment of the manufacturer’s production control, and

— the continuing surveillance of the effect on performance of certified AQME of subsequent changes.

This document follows the structure of EN ISO 9001:2015 such that clause numbers in Clause 4 to

Clause 10 coincide with those of EN ISO 9001:2015. Clause 11 provides additional requirements. This

document does not preclude the use of other QMS that are compatible with the objectives of

EN ISO 9001:2015.
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oSIST prEN 15267-2:2021
prEN 15267-2:2021 (E)
1 Scope

This document specifies the requirements for the manufacturer’s quality management system (QMS), the

initial assessment of the manufacturer’s production control and the continuing surveillance of the effect

of subsequent changes on the performance of certified air quality monitoring equipment (AQME).

This document also serves as a reference document for auditing the manufacturer’s QMS.

This document elaborates and supplements the requirements of EN ISO 9001:2015.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 9001:2015, Quality management systems - Requirements (ISO 9001:2015)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
3.1
air quality monitoring equipment
AQME
automated measuring system or data acquisition and handling system
[SOURCE: prEN 15267-1:2021, 3.1]
3.2
automated measuring system
AMS

entirety of all measuring instruments and additional devices for obtaining a result of measurement

Note 1 to entry: The term “automated measuring system” applies to stationary and portable AMS.

Note 2 to entry: Apart from the actual measuring device (the analyser), a stationary 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 QAL3 procedures and, if applicable, for commissioning.

Note 3 to entry: 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.
[SOURCE: prEN 15267-1:2021, 3.2]
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oSIST prEN 15267-2:2021
prEN 15267-2:2021 (E)
3.3
portable automated measuring system
P-AMS

automated measuring system which is in a condition or application to be moved from one to another

measurement site to obtain measurement results for a short measurement period
Note 1 to entry: The measurement period is typically 8 h for a day.

Note 2 to entry: The P-AMS can be configured at the measurement site for the special application but can be also

set-up in a van or mobile container. The probe and the sample gas lines are installed often just before the

measurement task is started.
[SOURCE: prEN 15267-1:2021, 3.3]
3.4
data acquisition and handling system
DAHS

system, which automatically receives, processes, stores and outputs data from automated measuring

systems
[SOURCE: prEN 15267-1:2021, 3.4]
3.5
product
air quality monitoring equipment
[SOURCE: prEN 15267-1:2021, 3.5]
3.6
testing laboratory
laboratory ca
...

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