Genetic Laboratories

Laboratory accreditation and certification

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There are number of ways in which genetic testing laboratories can assure quality, accreditation and certification are two of the possibilities. The key difference is that certification activity is based upon standards such as ISO 9001, which delineate the requirements for quality management systems and are applicable to any activity. Accreditation systems are based on standards like ISO 15189, ISO 17025, … that, in addition to requirements for quality management systems, have also ‘technical requirements’ that relate to achieving competence in all aspects of laboratory activity to ensure the results in reports are correct.

To be able to assess the quality in testing laboratories there are international and national standards that are followed and numerous guidelines and other documents that give support to implement a QMS.

Find an (accredited) genetics laboratory

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Find information on a genetic diseases, genetic tests and quality assurance practices (accreditation, participation in EQA) for laboratories across Europe.

Workshops and training for laboratories

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EuroGentest aims to aid laboratories in the process of implementing and developing a quality system, in improving existing quality schemes and working towards accreditation (ISO 15189). Therefore interactive workshops and web courses are organised.

Best practice and external quality assessment (EQA)

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Participation in EQA is an established tool for improving quality and assessing laboratory performance. In addition, EQA plays an important educational role and directs laboratories towards best practice guidelines.

Quality management system

A quality management system (QMS) is a web of interconnected structures, processes, procedures and recourses needed to implement quality management, and designed to ensure consistency and improvement in laboratories, which in turn should provide services that meet patient’s requirements.

Some elements of a QMS:

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Center for Human Genetics
University of Leuven
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