Guidelines and standards related to Quality Management

Accreditation

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.

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.

Certification

ISO 9001:2000 Quality management systems – Requirements

This standard contains the requirements for quality management systems only. It does not include technical and analytical competence requirements.

Molecular genetics

Best Practice Guidelines - Molecular Genetic Testing

Cytogenetics

Biochemical genetics

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