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SIST EN ISO 15189:2023/A11:2024

(Amendment)

Medical laboratories - Requirements for quality and competence

Medical laboratories - Requirements for quality and competence

Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz

Laboratoires médicaux - Exigences concernant la qualité et la compétence

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Medicinski laboratoriji - Zahteve za kakovost in kompetentnost - Dopolnilo A11

General Information

Status
Published
Publication Date
11-Dec-2023
ICS
03.120.10 - Quality management and quality assurance
11.100.01 - Laboratory medicine in general
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
23-Nov-2023
Due Date
28-Jan-2024
Completion Date
12-Dec-2023
Directive
765/2008 - REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
Mandate
M/580 - Standardisation request to the European Committee for Standardisation and the European Committee for Electrotechnical Standardisation in the area of accreditation and conformity assessment
Ref Project
EN ISO 15189:2022/A11:2023 - Medical laboratories - Requirements for quality and competence

Relations

Amends
SIST EN ISO 15189:2023 - Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
Effective Date
01-Jan-2024

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Standards Content (Sample)


SLOVENSKI STANDARD
SIST EN ISO 15189:2022/A11:2024
01-januar-2024
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost - Dopolnilo A11
Medical laboratories - Requirements for quality and competence
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz
Laboratoires médicaux - Exigences concernant la qualité et la compétence
Ta slovenski standard je istoveten z: EN ISO 15189:2022/A11:2023
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST EN ISO 15189:2022/A11:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 15189:2022/A11:2024

SIST EN ISO 15189:2022/A11:2024

EN ISO 15189:2022/A11
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 03.120.10; 11.100.01
English Version
Medical laboratories - Requirements for quality and
competence
Laboratoires médicaux - Exigences concernant la Medizinische Laboratorien - Anforderungen an die
qualité et la compétence Qualität und Kompetenz
This amendment A11 modifies the European Standard EN ISO 15189:2022; it was approved by CEN on 14 November 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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 ISO 15189:2022/A11:2023 E
worldwide for CEN national Members.

SIST EN ISO 15189:2022/A11:2024
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the
requirements of Regulation (EC) No 765/2008 of the European Parliament and of the
Council of 9 July 2008 setting out the requirements for accreditation and repealing
Regulation (EEC) No 339/93 aimed to be covered . 4

SIST EN ISO 15189:2022/A11:2024
European foreword
This document (EN ISO 15189:2022/A11:2023) has been prepared by Technical Committee CEN/TC
140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This Amendment to the
...


SLOVENSKI STANDARD
01-januar-2024
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost - Dopolnilo A11
Medical laboratories - Requirements for quality and competence
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz
Laboratoires médicaux - Exigences concernant la qualité et la compétence
Ta slovenski standard je istoveten z: EN ISO 15189:2022/A11:2023
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15189:2022/A11
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 03.120.10; 11.100.01
English Version
Medical laboratories - Requirements for quality and
competence
Laboratoires médicaux - Exigences concernant la Medizinische Laboratorien - Anforderungen an die
qualité et la compétence Qualität und Kompetenz
This amendment A11 modifies the European Standard EN ISO 15189:2022; it was approved by CEN on 14 November 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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 ISO 15189:2022/A11:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the
requirements of Regulation (EC) No 765/2008 of the European Parliament and of the
Council of 9 July 2008 setting out the requirements for accreditation and repealing
Regulation (EEC) No 339/93 aimed to be covered . 4

European foreword
This document (EN ISO 15189:2022/A11:2023) has been prepared by Technical Committee CEN/TC
140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This Amendment to the
...

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