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

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 proizvajalčevega sistema vodenja kakovosti in nadzor nad procesi proizvodnje po certificiranju

Ta dokument določa zahteve za proizvajalčev sistem vodenja kakovosti, prvotno oceno proizvajalčevega nadzora proizvodnje in stalno spremljanje vpliva naknadnih sprememb na delovanje certificirane opreme za monitoring kakovosti zraka.
Ta dokument se uporablja tudi kot referenčni dokument za revizijo proizvajalčevega sistema vodenja kakovosti.
Ta dokument natančneje določa in dopolnjuje zahteve standarda EN ISO 9001:2015.

General Information

• Status: Published
• Publication 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 9 - Quality assurance of automated measuring systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 05-Jul-2023
• Due Date: 02-Oct-2023
• Completion Date: 05-Jul-2023
• Directive: 2008/50/EC - Directive 2008/50/EC of the European Parliament and of the Council of 21 May 2008 on ambient air quality and cleaner air for Europe
• Ref Project: SIST 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

Relations

• Replaces: 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
• Effective Date: 28-Jan-2023

Overview

EN 15267-2:2023 - "Air quality - Assessment of air quality monitoring equipment - Part 2" specifies requirements for the manufacturer’s quality management system (QMS), the initial assessment of production control, and the post‑certification (continuing) surveillance of changes that could affect the performance of certified air quality monitoring equipment (AQME). Prepared by CEN and aligned with EN ISO 9001:2015, this standard is a reference for auditing manufacturers and supplements ISO 9001 with AQME‑specific guidance. It supersedes EN 15267-2:2009 and forms part of the EN 15267 series supporting AQME certification.

Key topics and requirements

• QMS requirements for manufacturers: expectations for documented information, competence, leadership, planning and operational controls as applied to AQME production (structured in line with EN ISO 9001:2015).
• Initial assessment: auditing the manufacturer’s production control and technical file to confirm the production process can reliably produce AQME that meet certified performance criteria.
• Continuing surveillance: procedures to monitor and assess the effect of subsequent design, process or component changes on certified equipment performance.
• Audit reference: the document serves as a reference for certification bodies and auditors when assessing manufacturer QMS and production control for AQME.
• Scope and definitions: clear terms for AQME, AMS (automated measuring systems), P‑AMS, DAHS, technical file, reference document and certification range.
• Structure and clause references: follows the ISO 9001 structure (sections on context, leadership, planning, support, operation, performance evaluation and assessment - see clauses 4–10).

Applications and users

Who uses EN 15267-2:2023?

• Manufacturers of automated measuring systems (AMS), portable AMS (P‑AMS) and data acquisition and handling systems (DAHS) who need to demonstrate compliant QMS and production control.
• Certification bodies performing initial assessments and ongoing surveillance for AQME certification.
• Testing laboratories and technical assessors involved in performance testing and certification workflows.
• Competent authorities and procurement teams referencing certified equipment for compliance with air quality and emissions legislation (e.g., IED, ambient air quality directives). Practical uses include preparing technical files, implementing controlled change procedures, and defining surveillance plans to ensure certified performance is maintained over the product life cycle.

Related standards

• EN 15267-1:2023 - General principles of certification for AQME
• EN 15267-3 and EN 15267-4 - Performance criteria and test procedures for stationary and portable automated measuring systems
• EN ISO 9001:2015 - QMS requirements (EN 15267-2 applies only in combination with ISO 9001)

Keywords: EN 15267-2:2023, air quality monitoring equipment, AQME, QMS, EN ISO 9001:2015, certification, surveillance, manufacturer production control, automated measuring system.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2023
Nadomešča:
SIST EN 15267-2:2009
Kakovost zraka - Ocenjevanje opreme za monitoring kakovosti zraka - 2. del:
Začetno ocenjevanje proizvajalčevega sistema vodenja kakovosti in nadzor nad
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
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
Ta slovenski standard je istoveten z: EN 15267-2:2023
ICS:
03.100.70 Sistemi vodenja Management systems
13.040.99 Drugi standardi v zvezi s Other standards related to air
kakovostjo zraka quality
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 15267-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 03.100.70; 13.040.99 Supersedes 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
Qualité de l'air - Évaluation des équipements de Luftbeschaffenheit - Beurteilung von Einrichtungen zur
surveillance de la qualité de l'air - Partie 2 : Évaluation Überwachung der Luftbeschaffenheit - Teil 2:
initiale du système de management de la qualité du Erstmalige Beurteilung des
fabricant et surveillance après certification du procédé Qualitätsmanagementsystems des Herstellers und
de fabrication Überwachung des Herstellungsprozesses nach der
Zertifizierung
This European Standard was approved by CEN on 24 April 2023.

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-CENELEC 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-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, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 15267-2:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Context of the organization . 9
5 Leadership . 9
5.1 Leadership and commitment . 9
5.2 Organization roles, responsibilities and authorities . 9
6 Planning . 9
7 Support . 10
7.1 Competence . 10
7.2 Documented information . 10
8 Operation . 10
8.1 Requirements for products and services . 10
8.2 Design and development of products and services . 11
8.3 Control of external provision of goods and services . 12
8.4 Production and service provision . 13
8.5 Control of non-conforming outputs . 13
9 Performance evaluation . 13
9.1 Monitoring, measurement, analysis and evaluation . 13
9.2 Management review . 13
10 Assessment . 13
10.1 Initial assessment . 13
10.2 Continuing surveillance . 14
Annex A (informative) Process for the control and assessment of changes . 15
Bibliography . 16

European foreword
This document (EN 15267-2:2023) 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 January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes 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
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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, Türkiye and the United
Kingdom.
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. This document can also be applied e.g. in the context of other national
legislation.
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 is based on EN ISO 9001 and supplements the requirements of EN ISO 9001 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 changes on the performance of
certified AQME. This document does not preclude the use of other QMS that are compatible with the
objectives of EN ISO 9001.
1 Scope
This document specifies requirements for the manufacturer’s quality management system (QMS).
Furthermore, it specifies requirements for 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 applies only in combination with EN ISO 9001.
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 15267-1:2023, Air Quality - Assessment of air quality monitoring equipment - Part 1: General principle
of certification
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: EN 15267-1:2023, 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), an AMS can include 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: FprEN 15267-1:2023, 3.2]
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: EN 15267-1:2023, 3.3]
3.4
data acquisition and handling system
DAHS
system, which automatically receives, processes, stores and outputs data from automated measuring
systems
[SOURCE: EN 15267-1:2023, 3.4]
3.5
product
air quality monitoring equipment
[SOURCE: EN 15267-1:2023, 3.5]
3.6
testing laboratory
laboratory carrying out the performance tests
[SOURCE: EN 15267-1:2023, 3.6]
3.7
manufacturer
organisation, situated at a st
...