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SIST ISO 15189:2023
01-januar-2023
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost
Medical laboratories - Requirements for quality and competence
Laboratoires de biologie médicale - Exigences concernant la qualité et la compétence
Ta slovenski standard je istoveten z: ISO 15189:2022
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 ISO 15189:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ISO 15189:2023
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SIST ISO 15189:2023
INTERNATIONAL ISO
STANDARD 15189
Fourth edition
2022-12
Medical laboratories — Requirements
for quality and competence
Laboratoires de biologie médicale — Exigences concernant la qualité
et la compétence
Reference number
ISO 15189:2022(E)
© ISO 2022
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SIST ISO 15189:2023
ISO 15189:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
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or ISO’s member body in the country of the requester.
ISO copyright office
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Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
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SIST ISO 15189:2023
ISO 15189:2022(E)
Contents Page
Foreword . vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 8
4.1 Impartiality . 8
4.2 Confidentiality . 8
4.2.1 Management of information . 8
4.2.2 Release of information . 9
4.2.3 Personnel responsibility . 9
4.3 Requirements regarding patients . 9
5 Structural and governance requirements . 9
5.1 Legal entity . 9
5.2 Laboratory director . 10
5.2.1 Laboratory director com
...