Nightingale's quality assurance

At Nightingale, we are committed to achieving high quality in all our services. Our sample analysis technology is used in clinical applications, which requires us to ensure compliance with the most stringent quality assurance and applicable regulatory requirements.

Certified quality management system

Nightingale operates under a certified quality management system in accordance with EN ISO 13485:2016 (certified by DEKRA Certification B.V.). All operations and processes involved in the analysis service fall under the QMS.

CE-marked technology

Nightingale measures all blood samples with a CE-marked IVD device. This means that samples are measured using the CE-marked IVD device that is used for the measurement of clinical samples for customers requiring the most stringent quality assurance.

Clinically and analytically validated biomarkers

37 of the biomarkers measured as part of our blood biomarker analysis service for the 350uL sample volume have been clinically and analytically validated. Read more about our clinical validations.

External quality assurance

Nightingale participates in UK NEQAS, WEQAS and Labquality external quality assurance programmes to monitor the measurement quality between Nightingale and other laboratories.

Healthcare quality

Nightingale's laboratories operate under a certified quality management system in accordance with EN ISO 13485:2016 and SFS-EN ISO/IEC 17025, and blood samples are measured with a CE-marked IVD device. Analytical performance for the CE-marked analytes is demonstrated according to CLIA's US FDA recognized consensus standards, and the CE-marked analytes are calibrated to the standard reference materials, if available, provided by the National Institute of Standards and Technology (NIST). Nightingale's laboratories have been accredited by Finnish Accreditation Service FINAS (testing laboratory T333, accreditation criteria SFS-EN ISO/IEC 17025). Scope of accreditation for clinical services and sites are available at www.finas.fi.

Information security management system certification

Nightingale has an ISO/IEC 27001 certified Information Security Management System. ISO/IEC 27001 is a globally recognized standard for information security management systems. With the Information Security Management System, Nightingale ensures that it maintains appropriate measures to secure data, products, and services. This information security certification also shows Nightingale's overall dedication to data security and commitment to continuously develop information security within the company.

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