99.60 Withdrawal effective Dec 14, 2022
CEN/TC 140 In vitro diagnostic medical devices
03.120.10 Quality management and quality assurance | 11.100.01 Laboratory medicine in general
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.
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 339/93Harmonized/Supporting
EN ISO 15189:2007
EN ISO 15189:2012
99.60 Withdrawal effective
Dec 14, 2022
EN ISO 15189:2022