99.60 Withdrawal effective Nov 1, 2012
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
03.120.10 Quality management and quality assurance | 11.100.01 Laboratory medicine in general
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.
Legislation related to this standard
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
WITHDRAWN
EN ISO 15189:2003
WITHDRAWN
EN ISO 15189:2007
99.60
Withdrawal effective
Nov 1, 2012
WITHDRAWN
EN ISO 15189:2012