ISO 15189:2003/DAmd 1

ISO 15189:2003/DAmd 1

Standards Content (sample)

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.

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© International Organization for Standardization, 2005
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ISO 15189:2003/DAmd 1
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ii ISO 2005 – All rights reserved
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ISO 15189:2003/DAM 1
Contents Page

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

Introduction.....................................................................................................................................................iv

© ISO 2005 – All rights reserved iii
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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 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.

Amendment 1 to ISO 15189:2005 was prepared by Technical Committee ISO/TC 212, Clinical laboratory

testing and in vitro diagnostic test systems.
iv © ISO 2005 – All rights reserved
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ISO 15189:2003/DAM 1
Introduction

In the longer term, ISO 15189 needs substantial revision. However, in the meantime TC 212 has undertaken

the task of making the changes necessary to preserve alignment with ISO/IEC 17025, taking into account the

changes made in the second edition of 17025, with a clear understanding that this should be done quickly.

The Final Draft Amendment (FDAM) to ISO/IEC 17025:1999 was approved in February 2005 by both ISO and

IEC. It is expected that the new edition of ISO/IEC 17025 will be published in June 2005.

In preparing the amendment to ISO/IEC 17025, CASCO/WG 25 decided not to undertake a full and

comprehensive alignment of 17025 with ISO 9001:2000, but rather to make only the minimum of changes that

were necessary to ensure that 17025 and ISO 9001:2000 were compatible. This included decoupling the

linkage between the two standards by removing the statement in the Scope that laboratories fulfilling the

requirements of 17025 also automatically fulfilled the requirements of ISO 9001:2000. Other changes are: the

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