EN ISO 15195:2003
(Main)Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included.
ISO 15195:2003 is not applicable to routine medical laboratories.
The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories".
ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.
Laboratoriumsmedizin - Anforderungen an Referenzmesslaboratorien (ISO 15195:2003)
Médecine de laboratoires - Exigences pour les laboratoires réalisant des mesurages de référence (ISO 15195:2003)
L'ISO 15195:2003 décrit les exigences spécifiques requises à l'égard des laboratoires qui effectuent des mesures de référence dans le domaine de la biologie médicale. Les examens des propriétés conduisant à des résultats exprimés selon une échelle nominale ou ordinale ne sont pas concernés.
L'ISO 15195:2003 n'est pas applicable aux laboratoires de biologie médicale effectuant des analyses en routine.
Il relève de la responsabilité du laboratoire de satisfaire aux exigences réglementaires en vigueur en matière d'hygiène et de sécurité.
Les exigences générales relatives à la compétence des laboratoires d'étalonnage sont fixées dans l'ISO/CEI 17025 qui se rapporte aux laboratoires d'étalonnages et d'essais. L'ISO 15195:2003 concerne les aspects spécifiques relatifs aux laboratoires d'étalonnage dans le domaine de la biologie médicale où ces «laboratoires d'étalonnage» sont généralement appelés «laboratoires réalisant des mesures de référence».
L'ISO 15195:2003 peut constituer une base pour l'accréditation d'un laboratoire réalisant des mesures de référence et demandant une reconnaissance officielle pour la mise en oeuvre d'un mode opératoire de mesure de référence. En général, les laboratoires réalisant des mesures de référence sont accrédités par les instituts nationaux de métrologie ou par des organismes nationaux d'accréditation.
Laboratorijska medicina – Zahteve za referenčne merilne laboratorije (ISO 15195:2003)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2003
/DERUDWRULMVNDPHGLFLQD±=DKWHYH]DUHIHUHQþQHPHULOQHODERUDWRULMH ,62
Laboratory medicine - Requirements for reference measurement laboratories (ISO
15195:2003)
Laboratoriumsmedizin - Anforderungen an Referenzmesslaboratorien (ISO 15195:2003)
Médecine de laboratoires - Exigences pour les laboratoires réalisant des mesurages de
référence (ISO 15195:2003)
Ta slovenski standard je istoveten z: EN ISO 15195:2003
ICS:
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.
EUROPEAN STANDARD
EN ISO 15195
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2003
ICS 11.100
English version
Laboratory medicine - Requirements for reference measurement
laboratories (ISO 15195:2003)
Médecine de laboratoires - Exigences pour les laboratoires Laboratoriumsmedizin - Anforderungen an
réalisant des mesurages de référence (ISO 15195:2003) Referenzmesslaboratorien (ISO 15195:2003)
This European Standard was approved by CEN on 24 July 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15195:2003 E
worldwide for CEN national Members.
Foreword
This document (EN ISO 15195:2003) 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 April 2004, and conflicting national
standards shall be withdrawn at the latest by April 2004.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 15195:2003 has been approved by CEN as EN ISO 15195:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 17511 2003 In vitro diagnostic medical devices - EN ISO 17511 2003
Measurement of quantities in biological
samples - Metrological traceability of
values assigned to calibrators and
control materials
ISO 18153 2003 In vitro diagnostic medical devices - EN ISO 18153 2003
Measurement of quantities in biological
samples - Metrological traceability of
values for catalytic concentration of
enzymes assigned to calibrators and
control materials
INTERNATIONAL ISO
STANDARD 15195
First edition
2003-10-01
Laboratory medicine — Requirements for
reference measurement laboratories
Médecine de laboratoires — Exigences pour les laboratoires réalisant
des mesurages de référence
Reference number
ISO 15195:2003(E)
©
ISO 2003
ISO 15195:2003(E)
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ii © ISO 2003 — All rights reserved
ISO 15195:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Management system requirements. 4
4.1 Organization and management . 4
4.2 Quality management system . 5
4.3 Personnel. 6
4.4 Measurement documentation and records . 6
4.5 Contracting . 6
5 Technical requirements. 7
5.1 Premises and environmental conditions. 7
5.2 Handling of samples . 7
5.3 Equipment. 7
5.4 Reference materials . 8
5.5 Reference measurement procedures. 8
5.6 Metrological traceability — Uncertainty of measurement . 8
5.7 Quality assurance . 9
5.8 Reporting results . 9
Annex A (informative) Cross-references to ISO/IEC 17025:1999. 11
Bibliography . 12
ISO 15195:2003(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 15195 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro
diagnostic test systems.
iv © ISO 2003 — All rights reserved
ISO 15195:2003(E)
Introduction
The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for
testing and calibration laboratories. This International Standard refers to the specific aspects 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 in order to allow
transferability of measurement results in patient samples irrespective of the place and time of measurement.
In order to achieve this goal, the first and essential step is to define the quantity to be measured. Once the
quantity has been defined, a reference measurement system should be established, consisting of
• reference materials,
• reference measurement procedures, and
• reference measurement laboratories.
The reference measurement laboratories should be embedded in international (global) networks organized
under the auspices of, for example, International Federation of Clinical Chemistry and Laboratory Medecine
(IFCC) and International Committee of weights and Measures (CIPM).
Reference measurement laboratories must operate with a traceability to the highest metrological level
available and with a lower uncertainty than routine laboratories. The metrological level of the results provided
by reference measurement laboratories should be appropriate to enable routine laboratories to fulfil medical
requirements. The specific requirements of medical laboratories carrying out routine measurements are
addressed in ISO 15189.
The presentation of reference measurement procedures and the description of reference materials are the
subject of ISO standards (ISO 15193 and ISO 15194, respectively). This International Standard describes the
performance characteristics required for reference measurement laboratories in laboratory medicine. These
are highly specialized laboratories often attached to or subcontracted by entities such as national metrology
institutes, quality assessment/proficiency testing organizations, academic centres, or in vitro diagnostic
medical device manufacturers.
Reference measurement 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).
In many instances, properties of biological materials cannot be expressed in SI uni
...
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