Blueprint Genetics becomes the first laboratory to receive ISO 15189 accreditation for a NGS pipeline from sample arrival to clinical interpretation

Published on February 2, 2016

Blueprint Genetics is now an ISO 15189 standard accredited No. T292 laboratory. Accreditation is a procedure to recognize an organization’s competence to carry out specific tasks based on internationally agreed criteria. The quality management system at Blueprint Genetics complies with the international ISO 15189 standard, which specifies the quality requirements for medical laboratories. For us, the accreditation is a recognition of the competence, reliability and credibility of the activities of our laboratory.

 

Blueprint Genetics was accredited on February 2nd2016 by FINAS and became the first laboratory providing ISO 15189 accredited genetic testing with next generation sequencing (NGS) technologies from sample arrival to clinical interpretation. We at Blueprint Genetics moved one step ahead of our competitors by building an ISO 15189 compliant NGS pipeline that includes every step from sample arrival to clinical interpretation for all current panels. This is an essential improvement in the quality as NGS services are many times provided by laboratories using experimental and non-validated protocols, sensitive to errors and misinterpretations due to high complexity of the testing. Johanna Jyrkkärinne, Quality Manager at Blueprint Genetics believes that the great effort in building an ISO 15189 compliant quality management system really benefits patients and sets a new standard for those providing services in the field.

FINAS (Finnish Accreditation Service)

is, according to the Finnish legislation (Act 1261/2010, amendment Act 763/2014), the national accreditation body responsible for organizing the accreditation activities according to the international criteria. FINAS offers accreditation services for testing and calibration laboratories, inspection bodies, certification bodies, providers of proficiency testing, GHG and EMAs verifiers. FINAS is a member of all multilateral recognition agreements/mutual recognition arrangements (MLA/MRA) signed by the European and international organizations, i.e. European co-operation for Accreditation (EA), International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum Inc. (IAF).

 

More information about the scope is available on the website, click here.

 

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