International and national standards, guidelines and other documents related to quality management

Accreditation standards


ISO published two standards that are specific for laboratories. ISO 15189 has recenlty been revised and published as ISO 15189:2012.

ISO standards can be bought via the ISO store:

ISO 17025:2005 General requirements for the competence of testing and calibration laboratories

This international standard contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a quality system, are technically competent and are able to generate technically valid results. Accreditation bodies that recognize the competence of testing and calibration laboratories should use this International Standards as a basis for their accreditation.

ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence

While ISO 17025 is simply recognition of competency of testing and calibration laboratories, this international standard provides requirements for competence and quality that are particular to medical laboratories. Medical laboratory services have to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Preferably, genetic testing laboratories implement a quality management system according the ISO 15189 requirements.

ISO 15189: 2012 Medical laboratories -- Requirements for quality and competence

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.

It is obligated to be followed from 2014.


In some European countries, groups of professionals developed national standards specific for medical laboratories. Examples are the Clinical Pathology Accreditation (CPA) which developed ‘Standards for the Medical Laboratory’, in use in the United Kingdom (UK) since 1992 and the Coördinatie Commissie ter bevordering van de Kwaliteitsbeheersing van het Laboratoriumonderzoek op het gebied van de Gezondheidszorg (CCKL) which published the ‘CCKL-Praktijkrichtlijn’, a Dutch standard in 1991. Current versions of these standards are based on the ISO 15189 requirements.

CCKL praktijkrichtlijn

This Dutch guideline is based on the ISO 15189 standard and applies to medical laboratories.

CPA standards for the medical laboratory

The CPA standard is the national guideline for accreditation of medical laboratories in the United Kingdom.

CAP 15189

In the US, the College of American Pathologists (CAP) published the CAP 15189 standard, based on ISO 15189.

Certification standard

ISO 9001:2008 Quality management systems -- Requirements


Other standards

The Clinical and Laboratory Standards Institute (CLSI), formerly National Committee on Clinical Laboratory Standards (NCCLS) has some documents that are relevant to a QMS in medical laboratories and can be found here.

HS1-A2 A quality management system model for health care

GP26-A3 Application of a quality management system model for laboratory services


Organisation for Economic Co-operation and Development (OECD) Guidelines for Quality Assurance in Genetic Testing (Download English pdf or French pdf )

World Health Organization. Laboratory quality management system: handbook.2011:

About EuroGentest
About Us
Standards Valid XHTML 1.0 Transitional Valid CSS!
European Union
Contact Information
Center for Human Genetics
University of Leuven
Herestraat 49 Box 602, 3000 Leuven, Belgium

Copyright EuroGentest2 Coordination Action 2011 - EU Contract no.: FP7 - HEALTH-F4-2010-261469