EN ISO/IEC 17043:2023
(Main)Conformity assessment - General requirements for the competence of proficiency testing providers (ISO/IEC 17043:2023)
Conformity assessment - General requirements for the competence of proficiency testing providers (ISO/IEC 17043:2023)
This document specifies general requirements for the competence and impartiality of proficiency
testing (PT) providers and consistent operation of all proficiency testing schemes. This document can
be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies and others can use these requirements in confirming or recognizing
the competence of proficiency testing providers.
Konformitätsbewertung - Allgemeine Anforderungen an die Kompetenz von Anbietern von Eignungsprüfungen (ISO/IEC 17043:2023)
Dieses Dokument legt allgemeine Anforderungen an die Kompetenz und Unparteilichkeit von Anbietern von Eignungsprüfungen(EP) und den konsistenten Ablauf sämtlicher Eignungsprüfungsprogramme fest. Dieses Dokument kann als Grundlage für spezifische technische Anforderungen für bestimmte Anwendungsfelder verwendet werden.
Anwender von Eignungsprüfungsprogrammen, Aufsichtsbehörden, Organisationen und Programme, die Begutachtung unter Gleichrangigen nutzen, Akkreditierungsstellen und andere können diese Anforderungen nutzen, um die Kompetenz von Anbietern von Eignungsprüfungen zu bestätigen oder anzuerkennen.
Évaluation de la conformité - Exigences générales concernant la compétence des organisateurs d’essais d’aptitude (ISO/IEC 17043:2023)
Ugotavljanje skladnosti - Splošne zahteve za usposobljenost ponudnikov preskušanja strokovne usposobljenosti (ISO/IEC 17043:2023)
Ta dokument določa splošne zahteve za usposobljenost in nepristranskost ponudnikov preskušanja strokovne usposobljenosti (PT) ter dosledno delovanje vseh shem za preskušanje strokovne usposobljenosti. Ta dokument je mogoče uporabiti kot osnovo za posebne tehnične zahteve za določena področja uporabe.
Uporabniki shem za preskušanje strokovne usposobljenosti, regulativni organi, organizacije in sheme, ki uporabljajo medsebojno ocenjevanje, akreditacijski organi ter drugi lahko uporabijo te zahteve za potrjevanje ali priznavanje usposobljenosti ponudnikov preskušanja strokovne usposobljenosti.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2023
Nadomešča:
SIST EN ISO/IEC 17043:2010
Ugotavljanje skladnosti - Splošne zahteve za usposobljenost ponudnikov
preskušanja strokovne usposobljenosti (ISO/IEC 17043:2023)
Conformity assessment - General requirements for the competence of proficiency testing
providers (ISO/IEC 17043:2023)
Konformitätsbewertung - Allgemeine Anforderungen an die Kompetenz von Anbietern
von Eignungsprüfungen (ISO/IEC 17043:2023)
Évaluation de la conformité - Exigences générales concernant la compétence des
organisateurs d’essais d’aptitude (ISO/IEC 17043:2023)
Ta slovenski standard je istoveten z: EN ISO/IEC 17043:2023
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN ISO/IEC 17043
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2023
ICS 03.120.20
Supersedes EN ISO/IEC 17043:2010
English version
Conformity assessment - General requirements for the
competence of proficiency testing providers (ISO/IEC
17043:2023)
Évaluation de la conformité - Exigences générales Konformitätsbewertung - Allgemeine Anforderungen
concernant la compétence des organisateurs d'essais an die Kompetenz von Anbietern von
d'aptitude (ISO/IEC 17043:2023) Eignungsprüfungen (ISO/IEC 17043:2023)
This European Standard was approved by CEN on 17 April 2023.
CEN and CENELEC 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 and CENELEC 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 and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees 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.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2023 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO/IEC 17043:2023 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO/IEC 17043:2023) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN-CENELEC/ JTC
1 “Criteria for conformity assessment bodies” the secretariat of which is held by BSI.
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 November 2023, and conflicting national standards
shall be withdrawn at the latest by November 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17043:2010.
This document has been prepared under a Standardization Request given to CEN and CENELEC by the
European Commission and the European Free Trade Association.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
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,
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.
Endorsement notice
The text of ISO/IEC 17043:2023 has been approved by CEN-CENELEC as EN ISO/IEC 17043:2023
without any modification.
INTERNATIONAL ISO/IEC
STANDARD 17043
Second edition
2023-05
Conformity assessment — General
requirements for the competence of
proficiency testing providers
Évaluation de la conformité — Exigences générales concernant la
compétence des organisateurs d’essais d’aptitude
Reference number
ISO/IEC 17043:2023(E)
© ISO/IEC 2023
ISO/IEC 17043:2023(E)
© ISO/IEC 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO/IEC 2023 – All rights reserved
ISO/IEC 17043:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Impartiality . 3
4.2 Confidentiality . 4
5 Structural requirements .4
6 Resource requirements .5
6.1 General . 5
6.2 Personnel . 5
6.3 Facilities and environmental conditions . 6
6.4 Externally provided products and services . 7
7 Process requirements . 8
7.1 Establishing, contracting and communicating the PT scheme objectives . 8
7.1.1 Review of requests, tenders and contracts . 8
7.1.2 PT scheme communication . 8
7.2 Design and planning of a PT scheme . 9
7.2.1 General . 9
7.2.2 Statistical design . 10
7.2.3 Determination of assigned values. 11
7.3 Production and distribution of PT items . 11
7.3.1 Production of PT items . 11
7.3.2 Homogeneity and stability assessment of PT items.12
7.3.3 Handling and storage of PT items .12
7.3.4 Packaging, labelling and distribution of PT items.12
7.3.5 Instructions for participants . 13
7.4 Evaluation and reporting of PT scheme results . 14
7.4.1 Data analysis . 14
7.4.2 Evaluation of performance . 14
7.4.3 PT reports.15
7.5 Control of the PT scheme process . 16
7.5.1 Technical records . 16
7.5.2 Control of data and information management . 16
7.5.3 Surveillance of the processes . 17
7.5.4 Nonconforming work . 17
7.6 Handling of complaints . 18
7.7 Handling of appeals . 19
8 Management system requirements .19
8.1 General requirements . 19
8.2 Management system documentation . 20
8.3 Control of management system documents . 20
8.4 Control of records . 20
8.5 Actions to address risks and opportunities .
...
SLOVENSKI STANDARD
01-julij-2023
Nadomešča:
SIST EN ISO/IEC 17043:2010
Ugotavljanje skladnosti - Splošne zahteve za preskušanje strokovne
usposobljenosti (ISO/IEC 17043:2023)
Conformity assessment - General requirements for the competence of proficiency testing
providers (ISO/IEC 17043:2023)
Konformitätsbewertung - Allgemeine Anforderungen an die Kompetenz von Anbietern
von Eignungsprüfungen (ISO/IEC 17043:2023)
Évaluation de la conformité - Exigences générales concernant la compétence des
organisateurs d’essais d’aptitude (ISO/IEC 17043:2023)
Ta slovenski standard je istoveten z: EN ISO/IEC 17043:2023
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN ISO/IEC 17043
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2023
ICS 03.120.20
Supersedes EN ISO/IEC 17043:2010
English version
Conformity assessment - General requirements for the
competence of proficiency testing providers (ISO/IEC
17043:2023)
Évaluation de la conformité - Exigences générales Konformitätsbewertung - Allgemeine Anforderungen
concernant la compétence des organisateurs d'essais an die Kompetenz von Anbietern von
d'aptitude (ISO/IEC 17043:2023) Eignungsprüfungen (ISO/IEC 17043:2023)
This European Standard was approved by CEN on 17 April 2023.
CEN and CENELEC 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 and CENELEC 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 and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees 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.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2023 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO/IEC 17043:2023 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO/IEC 17043:2023) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN-CENELEC/ JTC
1 “Criteria for conformity assessment bodies” the secretariat of which is held by BSI.
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 November 2023, and conflicting national standards
shall be withdrawn at the latest by November 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17043:2010.
This document has been prepared under a Standardization Request given to CEN and CENELEC by the
European Commission and the European Free Trade Association.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
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,
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.
Endorsement notice
The text of ISO/IEC 17043:2023 has been approved by CEN-CENELEC as EN ISO/IEC 17043:2023
without any modification.
INTERNATIONAL ISO/IEC
STANDARD 17043
Second edition
2023-05
Conformity assessment — General
requirements for the competence of
proficiency testing providers
Évaluation de la conformité — Exigences générales concernant la
compétence des organisateurs d’essais d’aptitude
Reference number
ISO/IEC 17043:2023(E)
© ISO/IEC 2023
ISO/IEC 17043:2023(E)
© ISO/IEC 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO/IEC 2023 – All rights reserved
ISO/IEC 17043:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Impartiality . 3
4.2 Confidentiality . 4
5 Structural requirements .4
6 Resource requirements .5
6.1 General . 5
6.2 Personnel . 5
6.3 Facilities and environmental conditions . 6
6.4 Externally provided products and services . 7
7 Process requirements . 8
7.1 Establishing, contracting and communicating the PT scheme objectives . 8
7.1.1 Review of requests, tenders and contracts . 8
7.1.2 PT scheme communication . 8
7.2 Design and planning of a PT scheme . 9
7.2.1 General . 9
7.2.2 Statistical design . 10
7.2.3 Determination of assigned values. 11
7.3 Production and distribution of PT items . 11
7.3.1 Production of PT items . 11
7.3.2 Homogeneity and stability assessment of PT items.12
7.3.3 Handling and storage of PT items .12
7.3.4 Packaging, labelling and distribution of PT items.12
7.3.5 Instructions for participants . 13
7.4 Evaluation and reporting of PT scheme results . 14
7.4.1 Data analysis . 14
7.4.2 Evaluation of performance . 14
7.4.3 PT reports.15
7.5 Control of the PT scheme process . 16
7.5.1 Technical records . 16
7.5.2 Control of data and information management . 16
7.5.3 Surveillance of the processes . 17
7.5.4 Nonconforming work . 17
7.6 Handling of complaints . 18
7.7 Handling of appeals . 19
8 Management system requirements .19
8.1 General requirements . 19
8.2 Management system documentation . 20
8.3 Control of management system documents . 20
8.4 Control of records . 20
8.5 Actions to address risks and opportunities .
...
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