Login

magnifying icon

Search a standard

Advanced search

Help

Satisfaction enquiry

Newsletter

Free of charge lifelong learning "Standardization"

Deliverable

  Free preview Price Language  
ILNAS-EN ISO 15189:2012 Edition 11/2012
Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
  •   
  •   
  •   
  •  
  • 60.6 / copy
  •  
Add to Basket

Abstract

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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 140 : In vitro diagnostic medical devices

Directives

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

Implementation

start of the vote on the project    06/01/2011   date of ratification (dor)    31/10/2012
end of the vote on the project    06/06/2011   date of anouncement (doa)    28/02/2013
start of the vote on the final project    09/08/2012   date of publication (dop)    31/05/2013
end of the vote on the final project    09/10/2012   date of withdrawal (dow)    30/11/2015


Publication Official Journal    05/06/2013

Relations

Evolutions

Relations to older standards
ILNAS-EN ISO 15189:2007

Relations to international standards
ISO 15189 
ISO 15189:2012 
ISO 15189:2012 

International Classification for Standards (ICS codes) :

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

Your feedback is important to us!


Would you be willing to give us a short feedback?


 


Thank you for helping us

Warning:
DIN standards can be downloaded only once! After downloading, they are no longer available in the eLibrary.
Begin download?