SIST EN ISO 15189:2003/oprA1:2005

SLOVENSKI SIST EN ISO
15189:2003/oprA1:2005
PREDSTANDARD
november 2005
Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost –
Dopolnilo 1 (ISO 15189:2003/DAM 1:2005)
Medical laboratories - Particular requirements for quality and competence -
Amendment 1 (ISO 15189:2003/DAM 1:2005)
ICS 03.120.10; 11.100.01 Referenčna številka
SIST EN ISO
15189:2003/oprA1:2005(en)
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

EUROPEAN STANDARD
DRAFT
EN ISO 15189:2003
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
September 2005
ICS
English Version
Medical laboratories - Particular requirements for quality and
competence - Amendment 1 (ISO 15189:2003/DAM 1:2005)
Laboratoires d'analyses de biologie médicale - Exigences
particulières concernant la qualité et la compétence (ISO
15189:2003/DAM 1:2005)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 140.
This draft amendment A1, if approved, will modify the European Standard EN ISO 15189:2003. If this draft becomes an amendment, 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.
This draft amendment was established by CEN 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15189:2003/prA1:2005:2005: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 15189:2003/prA1:2005) 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 document is currently submitted to the parallel Enquiry.

Endorsement notice
The text of ISO 15189:2003 has been approved by CEN as EN ISO 15189:2003/prA1:2005
without any modifications.
DRAFT AMENDMENT ISO 15189:2003/DAmd 1
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2005-09-08 2006-02-08
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Medical laboratories — Particular requirements for quality and
competence
AMENDMENT 1
Laboratoires d'analyses de biologie médicale — Exigences particulières concernant la qualité et la compétence
AMENDEMENT 1
ICS 03.120.10; 11.100.01
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2005

ISO 15189:2003/DAmd 1
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ii ISO 2005 – All rights reserved

ISO 15189:2003/DAM 1
Contents Page
Foreword .iv
Introduction.iv

ISO 15189:2003/DAM 1
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
...