EN ISO 15189:2007

Name: EN ISO 15189:2007
Brand: CEN
SKU: EN ISO 15189:2007
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Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007) EN ISO 15189:2007

Publication date: Oct 30, 2007

General information

Current stage: 99.60 Withdrawal effective Nov 1, 2012

Originator: CEN

Owner: CEN/TC 140 In vitro diagnostic medical devices

Type: European Norm

ICS: 03.120.10 Quality management and quality assurance | 11.100.01 Laboratory medicine in general

Buying

Status: Withdrawn

Scope

ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories.
ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

Related legislation

Legislation related to this standard

765/2008

REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

Harmonized/Supporting

Legislation 765/2008

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15189:2003

NOW

WITHDRAWN
EN ISO 15189:2007
99.60 Withdrawal effective
Nov 1, 2012

REVISED BY

WITHDRAWN
EN ISO 15189:2012