Air quality - Assessment of air quality monitoring equipment - Part 1: General principles of certification

This document specifies the general principles of certification, including common procedures and requirements, for the certification of air quality monitoring equipment (AQME).
This document applies to the certification of AQME for ambient air quality and emissions from stationary sources for which performance criteria and test procedures are available in European Standards.
This document provides for the certification of AQME according to the requirements of EN ISO/IEC 17065:2012.
This document elaborates and supplements the requirements of EN ISO/IEC 17065:2012 for bodies certifying AQME. It specifies requirements on testing laboratories as well as the manufacturer’s quality management system (QMS) and the surveillance for the manufacturing process as part of the certification process.

Luftbeschaffenheit - Beurteilung von Einrichtungen zur Überwachung der Luftbeschaffenheit - Teil 1: Grundlagen der Zertifizierung

Dieses Dokument legt die allgemeinen Zertifizierungsgrundsätze, einschließlich gemeinsamer Verfahren und Anforderungen, für die Zertifizierung von Einrichtungen zur Überwachung der Luftbeschaffenheit (AQME) fest.
Dieses Dokument gilt für die Zertifizierung von AQME für die Umgebungsluftbeschaffenheit und Emissionen aus stationären Quellen, für die Mindestanforderungen und Prüfverfahren in Europäischen Normen verfügbar sind.
Dieses Dokument sieht die Zertifizierung von AQME nach den Anforderungen der EN ISO/IEC 17065:2012 vor.
Dieses Dokument erläutert und ergänzt die Anforderungen der EN ISO/IEC 17065:2012 für Stellen, die AQME zertifizieren. Es legt Anforderungen an Prüflaboratorien sowie an das Qualitätsmanagementsystem (QMS) des Herstellers und die Überwachung des Herstellungsprozesses als Teil des Zertifizierungsprozesses fest.

Qualité de l’air - Évaluation des équipements de surveillance de la qualité de l’air - Partie 1 : Principes généraux de la certification

Le présent document spécifie les principes généraux, y compris les modes opératoires et les exigences communs, de la certification des équipements de surveillance de la qualité de l’air (AQME).
Le présent document s’applique à la certification des AQME destinés à la surveillance de la qualité de l’air ambiant et des émissions de sources fixes dont les critères de performances et les modes opératoires d’essai sont décrits dans des Normes européennes.
Le présent document prévoit la certification des AQME conformément aux exigences de l’EN ISO/IEC 17065:2012.
Le présent document précise et complète les exigences de l’EN ISO/IEC 17065:2012 pour les organismes de certification des AQME. Elle spécifie les exigences relatives aux laboratoires d’essai ainsi qu’au système de management de la qualité (SMQ) du fabricant et la surveillance du procédé de fabrication dans le cadre du processus de certification.

Kakovost zraka - Ocenjevanje opreme za monitoring kakovosti zraka - 1. del: Splošna načela certificiranja

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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 15267-1:2021
01-december-2021
Kakovost zraka - Ocenjevanje opreme za monitoring kakovosti zraka - 1. del:
Splošna načela certificiranja

Air quality - Assessment of air quality monitoring equipment - Part 1: General principles

of certification
Luftbeschaffenheit - Beurteilung von Einrichtungen zur Überwachung der
Luftbeschaffenheit - Teil 1: Grundlagen der Zertifizierung
Ta slovenski standard je istoveten z: prEN 15267-1
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 15267-1:2021 en,fr,de

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

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oSIST prEN 15267-1:2021
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oSIST prEN 15267-1:2021
DRAFT
EUROPEAN STANDARD
prEN 15267-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2021
ICS 13.040.99 Will supersede EN 15267-1:2009
English Version
Air quality - Assessment of air quality monitoring
equipment - Part 1: General principles of certification
Luftbeschaffenheit - Beurteilung von Einrichtungen zur
Überwachung der Luftbeschaffenheit - Teil 1:
Grundlagen 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 15267-1:2021 E

worldwide for CEN national Members.
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Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 5

4 General requirements ................................................................................................................................... 7

4.1 Legal and contractual matters .................................................................................................................... 7

4.2 Management of impartiality ........................................................................................................................ 8

4.3 Liability and financing ................................................................................................................................... 8

4.4 Non-discriminatory conditions .................................................................................................................. 8

4.5 Confidentiality .................................................................................................................................................. 8

4.6 Publicly available information ................................................................................................................... 8

5 Structural requirements ............................................................................................................................... 8

5.1 Organizational structure and top management ................................................................................... 8

5.2 Mechanism for safeguarding impartiality .............................................................................................. 8

6 Resource requirements ................................................................................................................................ 9

6.1 Certification body personnel ...................................................................................................................... 9

6.2 Resources for evaluation .............................................................................................................................. 9

7 Process requirements ................................................................................................................................... 9

7.1 General ................................................................................................................................................................ 9

7.2 Application ..................................................................................................................................................... 13

7.3 Application review ....................................................................................................................................... 14

7.4 Evaluation ....................................................................................................................................................... 14

7.5 Review .............................................................................................................................................................. 14

7.6 Certification decision .................................................................................................................................. 14

7.7 Certification documentation .................................................................................................................... 14

7.8 Directory of certified products ................................................................................................................ 15

7.9 Surveillance .................................................................................................................................................... 15

7.10 Changes affecting certification ................................................................................................................ 15

7.11 Termination, reduction, suspension or withdrawal of certification ......................................... 15

7.12 Records ............................................................................................................................................................ 15

7.13 Complaints and appeals ............................................................................................................................. 15

8 Management system requirements ....................................................................................................... 16

Annex A (informative) Application and assessment processes ................................................................ 17

Annex B (informative) Example certificate template................................................................................... 18

Bibliography ................................................................................................................................................................. 20

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European foreword

This document (prEN 15267-1:2021) 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 15267-1:2009.
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 15267-1 has been clarified to make it clear that only Part 1 deals with the basic

principles of the certification of air quality monitoring equipment.

c) The revised EN15267-1 is based on EN ISO/IEC 17065:2012 and is identically structured. It provides

guidance on the application of EN ISO/IEC 17065:2012 to the certification of AQME for monitoring

ambient air quality and emissions from stationary sources. It supplements EN ISO/IEC 17065:2012

by providing clarification and additional information. However, it does not re-state all the provisions

of EN ISO/IEC 17065:2012 and users are reminded of the need to comply with all of the relevant

criteria detailed in EN ISO/IEC 17065:2012.

d) The basic contents of EN 15267-1:2009 were largely adopted, updated and inserted into the

structure of EN ISO/IEC 17065:2012.

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

“certification body”.
This document is Part 1 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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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

complies with performance criteria, maximum permissible measurement uncertainties and test

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.

This document is based on EN ISO/IEC 17065:2012 and defines common procedures and requirements

for the certification of AQME to facilitate mutual recognition and thereby minimize administrative and

cost burdens on manufacturers seeking certification in multiple member states. It also describes the roles

and responsibilities of manufacturers, testing laboratories and certification bodies.

EN ISO/IEC 17065:2012 specifies general criteria that a certification body operating product certification

shall follow if it is to be recognized at a national or European level as competent and reliable in the

operation of a product certification system, irrespective of the sector involved. It is intended for the use

of accreditation bodies concerned with recognizing the competence of certification bodies.

EN ISO/IEC 17065 recognizes that these general criteria may have to be supplemented when applied to

a particular sector. This document provides guidance on the application of EN ISO/IEC 17065:2012 to

the certification of AQME for monitoring ambient air quality and emissions from stationary sources. This

document supplements EN ISO/IEC 17065:2012 by providing clarification and additional information.

However, it does not re-state all the provisions of EN ISO/IEC 17065:2012 and users are reminded of the

need to comply with all of the relevant criteria detailed in EN ISO/IEC 17065:2012.

Assessment and the included certification of AQME form the basis for the legal approval of this

equipment. However, this document does not define the process for the legal approval of AQME. The

responsibility for approving automated measuring systems (AMS) for monitoring ambient air quality

under Directive 2008/50/EC lies with the national competent authority or a body designated by the EU

member state. No explicit requirement for approving automated measuring systems (AMS) and data

acquisition and handling systems (DAHS) for monitoring emissions from stationary sources is defined in

the relevant EU Directives, although the competent authorities in some EU member states have such

arrangements in place. Additionally, the IED and its implementing measures (BAT Conclusions Decision

Documents) prescribe the use of European Standards for monitoring, whilst approval schemes are a

means for both suppliers and users of AQME to demonstrate compliance with the requirement of

applicable European Standards.

In some EU member states the competent authority delegates the responsibility for approval of AQME to

a certification body accredited to EN ISO/IEC 17065:2012 by national accreditation bodies.

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1 Scope

This document specifies the general principles of certification, including common procedures and

requirements, for the certification of air quality monitoring equipment (AQME).

This document applies to the certification of AQME for ambient air quality and emissions from stationary

sources for which performance criteria and test procedures are available in European Standards.

This document provides for the certification of AQME according to the requirements of

EN ISO/IEC 17065:2012.

This document elaborates and supplements the requirements of EN ISO/IEC 17065:2012 for bodies

certifying AQME. It specifies requirements on testing laboratories as well as the manufacturer’s quality

management system (QMS) and the surveillance for the manufacturing process as part of the certification

process.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

EN ISO 19011, Guidelines for auditing management systems (ISO 19011)

EN ISO/IEC 17065:2012, Conformity assessment — Requirements for bodies certifying products, processes

and services (ISO/IEC 17065:2012)

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
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
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

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(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.
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.
3.4
data acquisition and handling system
DAHS

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

systems
3.5
product
air quality monitoring equipment
3.6
testing laboratory
laboratory carrying out the performance test
3.7
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 1 to entry: The term “manufacturer” is used instead of “organisation” as used in EN ISO 9001. For the

purpose of this document they are interchangeable.
3.8
certification body
third-party conformity assessment body operating certification schemes
[SOURCE: EN ISO/IEC 17065:2012, 3.12]
3.9
technical file
record of the reference documents and changes to the reference documents
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3.10
reference document

document that controls the manufacture and design of air quality monitoring equipment and is

referenced in the test report

Note 1 to entry: Reference documents can include drawings, specifications, instructions and computer code.

3.11
related document
document not referenced in the test report

Note 1 to entry A related document can be used, for example, for the detailed manufacture of

component parts.
3.12
certification range

range over which the automated measuring system is tested and certified for compliance with the

relevant performance criteria
Note 1 to entry: The lower limit of the certification range is usually zero.

Note 2 to entry: Generally, the lower the certification range, the better the performance of the AMS. Also an AMS

typically performs satisfactorily at higher values over the measurement range.
3.13
surveillance

systematic iteration of conformity assessment activities as a basis for maintaining the validity of the

statement of conformity
[SOURCE: EN ISO/IEC 17000:2020, 8.1]

Note 1 to entry: For the purposes of this document surveillance focuses on the manufacturer’s QMS to ensure

that AQME continue to comply with the standard to which they are certified.
3.14
competent authority

organisation which implements the requirements of legislation and regulates installations

3.15
legislation
directives, acts, ordinances and regulations
4 General requirements
4.1 Legal and contractual matters
4.1.1 Legal responsibility
The requirements of EN ISO/IEC 17065:2012, 4.1.1, and the following apply.

The certification body shall liaise as appropriate with the relevant national competent authority.

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4.1.2 Certification agreement
The requirements of EN ISO/IEC 17065:2012, 4.1.2, apply.
4.1.3 Use of license, certificates and marks of conformity
The requirements of EN ISO/IEC 17065:2012, 4.1.3, apply.
4.2 Management of impartiality
The requirements of EN ISO/IEC 17065:2012, 4.2, apply.
4.3 Liability and financing
The requirements of EN ISO/IEC 17065:2012, 4.3, apply.
4.4 Non-discriminatory conditions
The requirements of EN ISO/IEC 17065:2012, 4.4, apply.
4.5 Confidentiality
The requirements of EN ISO/IEC 17065:2012, 4.5, apply.
4.6 Publicly available information
The requirements of EN ISO/IEC 17065:2012, 4.6, and the following apply.
The certification body shall
— issue certificates with an appropriate scope of certification;

— issue certificates in at least one of the three principal CEN languages, i.e. English, French or German.

NOTE The scope of certification includes e.g. for AMS the measured components, certification ranges, process

applications and any limitations of use.
5 Structural requirements
5.1 Organizational structure and top management
The requirements of EN ISO/IEC 17065:2012, 5.1, and the following apply.

The certification body shall have in place appropriate procedures for the certification of AQME in

accordance with the requirements of this document.

NOTE The competence for certification of AQME in accordance with the requirements of this document can be

demonstrated by an accreditation to EN ISO/IEC 17065.
5.2 Mechanism for safeguarding impartiality
The requirements of EN ISO/IEC 17065:2012, 5.2, and the following apply.
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6 Resource requirements
6.1 Certification body personnel
6.1.1 General
The requirements of EN ISO/IEC 17065:2012, 6.1.1, and the following apply.

6.1.2 Management of competence for personnel involved in the certification process

The requirements of EN ISO/IEC 17065:2012, 6.1.2, and the following apply.

Personnel involved in the certification process shall know and understand the applicable European

Standards for AQME.
6.1.3 Contract with the personnel
The requirements of EN ISO/IEC 17065:2012, 6.1.3, apply.
6.2 Resources for evaluation
6.2.1 Internal resources
The requirements of EN ISO/IEC 17065:2012, 6.2.1, and the following apply.

If the testing laboratory is part of the certification body, the requirements of 7.1.1.3.2 apply.

6.2.2 External resources (outsourcing)
The requirements of EN ISO/IEC 17065:2012, 6.2.2, apply.
7 Process requirements
7.1 General
7.1.1 Certification schemes
7.1.1.1 General

The requirements of EN ISO/IEC 17065:2012, 7.1.1, and the requirements specified in 7.1.1.2 and 7.1.1.3

apply.
7.1.1.2 Assessment of AQME
7.1.1.2.1 General
The assessment of AQME consists of the following sequential stages:
a) performance test;
b) initial assessment of the manufacturer’s QMS;
c) certification;
d) surveillance for the manufacturing process.
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Annex A, Figure A.1 illustrates the main stages involved in obtaining certification of AQME. These stages

are specified in 7.1.1.2.2 to 7.1.1.2.5.

The roles and responsibilities of the certification body, the testing laboratory and the manufacturer are

specified in 7.1.1.3.
7.1.1.2.2 Performance test

The performance test of AMS consists of a combination of laboratory and field testing. DAHS for

monitoring stationary source emissions are tested in the laboratory only.

Laboratory testing is designed to assess whether AQME can meet, under controlled conditions, the

performance criteria specified for the relevant performance characteristics. Field testing is designed to

assess whether AMS can continue to work and meet the relevant performance criteria in a real

application. For emissions monitoring, field testing is carried out on an industrial installation

representative of the intended application for the AMS for which the manufacturer seeks certification.

For ambient air monitoring AMS field testing is carried out at sites as specified in the Directive

2008/50/EC as well as in the corresponding European Standards.

AQME is tested to evaluate its performance against criteria specified in an applicable European Standard

for the performance and testing of AQME. The performance test is carried out by a testing laboratory

having the competence to perform the test procedures specified in the applicable standard.

NOTE The necessary competence to perform the test procedures can be demonstrated e.g. by an accreditation

according to EN ISO/ISO 17025, with the applicable European Standards in the scope of accreditation.

The applicable standards for testing AQME include:

— EN 15267-3 for stationary AMS for monitoring emissions from stationary sources;

— EN 15267-4 for P-AMS for periodic measurements of emissions from stationary sources;

— EN 14884 for stationary AMS for measurements of mercury emissions from stationary sources;

— EN ISO 16911-2 for measurement of volumetric flow at stationary sources;

— EN 17255-1, EN 17255-2 and EN 17255-3 for DAHS for monitoring emissions from stationary

sources;

— EN 14211, EN 14212, EN 14625, EN 14626, EN 14662-3 and EN 16450 for AMS for monitoring

ambient air quality;

— other European Standards currently under preparation that specify performance criteria and test

procedures for AQME for monitoring emissions from stationary sources or monitoring ambient air

quality.
7.1.1.2.3 Initial assessment of the manufacturer’s QMS

AQME typically undergo changes during the production life and it is essential to ensure that after such

changes, the AQME still meet the required performance criteria. Therefore, in order to meet these

performance criteria the manufacturer shall control the production and design of AQME using a QMS,

which meets the requirements specified in EN 15267-2.

Compliance with the requirements of EN 15267-2 shall be determined by an initial assessment of the

manufacturer’s QMS. This initial assessment can be carried out by
a) the certification body, or
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b) a party acting on behalf of the certification body, or

c) a competent third-party certification body if the requirements of EN 15267-2 have been

incorporated into a certified QMS (e.g. EN ISO 9001), where the initial assessment can focus only on

the additional requirements of EN 15267-2.
7.1.1.2.4 Certification

If manufacturers, testing laboratories, and certification bodies meet the requirements of the European

Standards for AQME, then such compliance provides the means for mutual recognition between

certification bodies.
7.1.1.2.5 Surveillance for the manufacturing process

Following certification, the certification body shall ensure that surveillance of the manufacturing process

and performance of the certified AQME is periodically carried out to determine continued conformance

with the applicable European Standard. This surveillance shall involve audits of the manufacturer’s

quality control of changes, manufacture of the AQME, and effective responses to complaints from users.

7.1.1.3 Roles and responsibilities
7.1.1.3.1 Certification body
The certification body is responsible for the whole certification process.
The certification body shall
— be competent for the certification of AQME;

— provide guidance on the arrangements and requirements for certification to the manufacturer,

testing laboratory and the certification body for QMS if the manufacturer has incorporated the

requirements of EN 15267-2 into a certified QMS;

— assess test reports and determine whether the testing laboratory is appropriately accredited to carry

out the tests and whether the data support the application for certification including the proposed

scope;

— verify the evidence that the AQME manufacturer has a QMS which complies with the requirements of

EN 15267-2.

NOTE 1 If a manufacturer has incorporated the requirements of EN 15267-2 into a certified QMS (e.g.

EN ISO 9001) the initial assessment
...

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