Accreditation

Accreditation

"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, most importantly ISO 15189 or ISO 17025.

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

The accreditation body shall accredit independent entities, in accordance with the standards and procedures.
To find the accreditation body in your country, visit the website of the European co-operation for Accreditation (EA) .

Find an accredited lab

You can find out which labs are accredited across Europe using the QAu database search engine .

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.

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.

Workshops/Training

Workshops on accreditation

Last changed: 2009-01-16