prEN 15267-2

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

DRAFT
EUROPEAN STANDARD
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.

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
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
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 su
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