"Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks." (ISO guide2)

Formal recognition of technical competence, as well as compliance to a quality management system. Central to accreditation are two features: the principle of external review, with regular external audits carried out by an independent body; and to fulfil the requirements of standards.

In other words, laboratories that have been successfully reviewed by a recognized accreditation body prove to be competent to perform specific types of testing by complying with specific management and technical requirements. These requirements are described in standards such as those listed below.

See also: certification , which requires external audit of compliance to a QMS, but not of technical competence; and licensing , which is usually mandatory and government-imposed and which may or may not involve criteria of quality.

Accreditation bodies

Accreditation bodies assess laboratories against internationally-agreed standards, preferable the ISO 15189 standard for (genetic) medical testing laboratories in Europe. Following the implementation of European Regulation EC 765/2008, there can only be one recognized national accreditation body (NAB) per European country.These NABs should comply with ISO 17011. The European network of recognized NABs in Europe is the European co-operation for Accreditation (EA).

To find the accreditation body in your country, visit the website of the European co-operation for Accreditation (EA) .

Accreditation benefits

A formal accreditation and the linked periodical audits are a stimulant for keeping the quality system alive. Without accreditation there is a danger of giving less attention to quality improvement. In addition, accreditation is a good way to demonstrate and attest competence and a world-wide tool to recognize laboratories. Finally there is a benefit for all parties (patients, families, the laboratory and clinicians) through better processes and quality of results.

Accreditation standards

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.

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.

Accreditation and certification confusion

Although accreditation and certification are clearly defined by ISO, a widespread confusion exists and the terms have being used interchangeable and are poorly understood. However, accreditation is one step higher in the hierarchy than certification. The key difference is that technical procedures, competence and expertise are (accreditation), or are not (certification) included in the obligatory evaluation.

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