Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].

Laboratoriumsmedizin - Anforderungen an die Kompetenz von Kalibrierlaboratorien mit Referenzmessverfahren (ISO 15195:2018)

Dieses Dokument legt, unter Verwendung der Anforderungen von ISO/IEC 17025:2017 als normative Verweisung, die Anforderungen an die Kompetenz zur Durchführung von Referenzmessverfahren in der Laboratoriumsmedizin fest und listet weitere Anforderungen an Kalibrierlaboratorien auf, damit diese ihre Aufgaben adäquat ausführen.
Der Zusammenhang zwischen Abschnitten dieses Dokument und ISO/IEC 17025:2017 ist in Anhang A erläutert.
Die Untersuchung von Eigenschaften, deren Ergebnisse auf Nominal  oder Ordinalskalen dargestellt werden, gehört nicht zum Anwendungsbereich dieser Norm.
Dieses Dokument ist nicht auf medizinische Laboratorien anwendbar.
ANMERKUNG   Die Anforderungen an medizinische Laboratorien sind in ISO 15189 [1] festgelegt.

Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage utilisant des procédures de mesure de référence (ISO 15195:2018)

Le présent document spécifie les exigences relatives à la compétence des laboratoires d'étalonnages utilisant des procédures de mesure de référence dans le domaine de la biologie médicale, en appliquant les exigences de l'ISO/IEC 17025:2017 comme référence normative et en répertoriant les exigences supplémentaires applicables pour que les laboratoires d'étalonnages puissent s'acquitter de leur tâche de manière appropriée.
La relation entre les articles et paragraphes du présent document et ceux de l'ISO/IEC 17025:2017 est résumée dans l'Annexe A.
Les examens dont les propriétés conduisent à des résultats exprimés selon une échelle nominale ou ordinale ne sont pas concernés.
Le présent document n'est pas applicable aux laboratoires de biologie médicale.
NOTE Les exigences applicables aux laboratoires de biologie médicale sont spécifiées dans l'ISO 15189[1].

Laboratorijska medicina - Zahteve za usposobljenost kalibracijskih laboratorijev z uporabo referenčnih merilnih postopkov (ISO 15195:2018)

Ta dokument določa zahteve za usposobljenost za izvajanje referenčnih merilnih postopkov v laboratorijski medicini na podlagi zahtev standarda ISO/IEC 17025:2017 kot normativne reference, navaja pa tudi dodatne zahteve, ki jih morajo upoštevati kalibracijski laboratoriji za ustrezno izvajanje opravil.
Razmerje med točkami tega dokumenta in standardom ISO/IEC 17025:2017 so povzeti v dodatku A.
Preskusi lastnosti z rezultati, o katerih se poroča po nominalni ali razvrstitveni lestvici, niso zajeti.
Ta dokument se ne uporablja za medicinske laboratorije.
OPOMBA: Zahteve za naprave za medicinske laboratorije so določene v standardu ISO 15189[1].

General Information

Status
Published
Publication Date
05-Feb-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
06-Feb-2019
Completion Date
06-Feb-2019

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SLOVENSKI STANDARD
SIST EN ISO 15195:2019
01-april-2019
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SIST EN ISO 15195:2003

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Laboratory medicine - Requirements for the competence of calibration laboratories using

reference measurement procedures (ISO 15195:2018)

Laboratoriumsmedizin - Anforderungen an die Kompetenz von Kalibrierlaboratorien mit

Referenzmessverfahren (ISO 15195:2018)

Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage

utilisant des procédures de mesure de référence (ISO 15195:2018)
Ta slovenski standard je istoveten z: EN ISO 15195:2019
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST EN ISO 15195:2019 en

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

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SIST EN ISO 15195:2019
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SIST EN ISO 15195:2019
EN ISO 15195
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2019
EUROPÄISCHE NORM
ICS 11.100.99 Supersedes EN ISO 15195:2003
English Version
Laboratory medicine - Requirements for the competence
of calibration laboratories using reference measurement
procedures (ISO 15195:2018)

Biologie médicale - Exigences relatives à la compétence Laboratoriumsmedizin - Anforderungen an die

des laboratoires d'étalonnage utilisant des procédures Kompetenz von Kalibrierlaboratorien mit

de mesure de référence (ISO 15195:2018) Referenzmessverfahren (ISO 15195:2018)
This European Standard was approved by CEN on 7 December 2018.

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. 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 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 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey 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

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15195:2019 E

worldwide for CEN national Members.
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SIST EN ISO 15195:2019
EN ISO 15195:2019 (E)
Contents Page

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

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SIST EN ISO 15195:2019
EN ISO 15195:2019 (E)
European foreword

This document (EN ISO 15195:2019) has been prepared by Technical Committee ISO/TC 212 "Clinical

laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee

CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.

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 August 2019, and conflicting national standards shall

be withdrawn at the latest by February 2022.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 15195:2003.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association.

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, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 15195:2018 has been approved by CEN as EN ISO 15195:2019 without any modification.

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SIST EN ISO 15195:2019
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SIST EN ISO 15195:2019
INTERNATIONAL ISO
STANDARD 15195
Second edition
2018-12
Laboratory medicine — Requirements
for the competence of calibration
laboratories using reference
measurement procedures
Biologie médicale — Exigences relatives à la compétence des
laboratoires d'étalonnage utilisant des procédures de mesure de
référence
Reference number
ISO 15195:2018(E)
ISO 2018
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SIST EN ISO 15195:2019
ISO 15195:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 15195:2019
ISO 15195:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 General requirements ..................................................................................................................................................................................... 2

5 Structural requirements .............................................................................................................................................................................. 3

6 Resource requirements ................................................................................................................................................................................. 3

6.1 General ........................................................................................................................................................................................................... 3

6.2 Personnel ..................................................................................................................................................................................................... 3

6.3 Laboratory facilities and environmental conditions .............................................................................................. 3

6.4 Equipment ................................................................................................................................................................................................... 3

6.5 Metrological traceability ................................................................................................................................................................. 4

6.6 Reference materials ............................................................................................................................................................................ 4

6.7 Externally provided products and services .................................................................................................................... 4

7 Process requirements ..................................................................................................................................................................................... 5

7.1 R eview of requests, tender and contracts ....................................................................................................................... 5

7.2 Reference measurement procedures ................................................................................................................................... 5

7.3 Handling of samples ........................................................................................................................................................................... 5

7.4 Measurement records ....................................................................................................................................................................... 5

7.5 E valuation of measurement uncertainty .......................................................................................................................... 5

7.6 Ensuring the validity of measurement results ............................................................................................................ 6

7.7 Reporting measurement results .............................................................................................................................................. 6

8 Management requirements ....................................................................................................................................................................... 6

8.1 General ........................................................................................................................................................................................................... 6

8.2 Internal audits ......................................................................................................................................................................................... 6

Annex A (informative) Relationship to ISO/IEC 17025:2017...................................................................................................... 7

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2018 – All rights reserved iii
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SIST EN ISO 15195:2019
ISO 15195:2018(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in

vitro diagnostic test systems.

This second edition cancels and replaces the first edition (ISO 15195:2003), which has been technically

revised.
The main changes compared to the previous edition are as follows:
— inclusion of ISO/IEC 17025:2017 as a normative reference;
— removal of clauses that duplicate requirements in ISO/IEC 17025:2017;

— reorganization of this document so that it follows the structure of ISO/IEC 17025:2017.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 15195:2019
ISO 15195:2018(E)
Introduction

The general requirements for the competence of calibration laboratories are specified in ISO/

IEC 17025:2017 for testing and calibration laboratories. This document refers to the additional aspects

for the competence of calibration laboratories in the field of laboratory medicine where such “calibration

laboratories” are usually denoted as “reference measurement laboratories”.

The results produced by medical laboratories should be traceable to reference materials and/or

reference measurement procedures of higher order, whenever these are available. This is necessary to

allow transferability of measurement results in patient samples irrespective of the place and time of

measurement.

The metrological level of the results provided by calibration laboratories should be appropriate to

support medical laboratories to fulfil medical requirements. The specific requirements of medical

laboratories are addressed in ISO 15189.

Calibration laboratories should implement reference measurement procedures and produce results of

measurement that are accurate and traceable to national or international primary reference materials

when such are available. Whenever possible, traceability should be established to a reference material

which forms an embodiment of the SI unit (ISO 17511).

The calibration laboratory should provide traceable values on reference materials supplied by

customers to the highest available level of reference measurement procedures or reference materials.

In many instances, properties of biological materials cannot be expressed in SI units because the

molecular structure of their analytes is not exactly known and can be different in a reference material

from that in a native sample of human origin (e.g. state of glycosylation of a protein).

Even if the value for a property of a biological material is not traceable to an SI unit, each step of a

reference measurement procedure (e.g. gravimetry, volumetry, thermometry, potentiometry) should

have values that are traceable to the respective SI unit.

The traceability concept, including its applicability and limitations are described in detail in ISO 17511.

The requirements described in this document and in ISO/IEC 17025:2017 are prerequisites for

calibration laboratories to perform their tasks adequately.

This document may form a basis for the accreditation of a calibration laboratory that applies for

recognition of the performance of a reference measurement procedure.
© ISO 2018 – All rights reserved v
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SIST EN ISO 15195:2019
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SIST EN ISO 15195:2019
INTERNATIONAL STANDARD ISO 15195:2018(E)
Laboratory medicine — Requirements for the competence
of calibration laboratories using reference measurement
procedures
1 Scope

This document specifies the requirements for competence to carry out reference measurement

procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative

reference and listing additional requirements for calibration laboratories to perform their tasks

adequately.

The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in

Annex A.

Examinations of properties with results reported on a nominal or ordinal scale are not included.

This document is not applicable to medical laboratories.
[1]
NOTE Requirements for medical laboratories are specified in ISO 15189 .
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

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

ISO/IEC Guide 98-3, Uncertainty of measurement — Part 3: Guide to the expression of uncer

...

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