EN ISO 15189:2012

Name: EN ISO 15189:2012
Brand: CEN
SKU: EN ISO 15189:2012
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Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) EN ISO 15189:2012

Publication date: Dec 18, 2012

General information

Current stage: 99.60 Withdrawal effective Dec 14, 2022

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: Published

Scope

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

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WITHDRAWN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 15189:2007

NOW

WITHDRAWN
EN ISO 15189:2012
99.60 Withdrawal effective
Dec 14, 2022

REVISED BY

PUBLISHED
EN ISO 15189:2022