Accreditation

Accreditation is the official recognition of a laboratory’s suitability and compliance in providing specific services. In the healthcare and diagnostic fields, accreditation ensures that test results are reliable, repeatable, and compliant with international standards.

Each country in Europe has its own national accreditation body. In Italy, the national accreditation body is ACCREDIA, designated by the Italian government in accordance with European Regulation 765/2008. ACCREDIA is responsible for certifying the competence, independence, and impartiality of certification, inspection, and verification bodies, as well as medical laboratories. It is also connected to international networks of accreditation bodies.

The accreditation body, which is independent and representative of all stakeholders, ensures that accredited laboratories perform analyses with competence, independence, and impartiality, through regular technical assessments.

Accredited medical laboratories are able to provide the market with guarantees on the reliability of their results, precisely because of their accreditation. It is therefore essential to distinguish between:

• ISO 9001 certification, which refers to a laboratory’s quality management system and is issued by a certification body;
• and ISO/IEC 15189 accreditation, which refers to the laboratory itself and is issued by a national accreditation body.

The ISO 15189 standard is the international benchmark specifically developed for medical laboratories. It defines the quality and competence requirements a laboratory must meet to ensure accurate results and a patient-centered service.

The main requirements of ISO 15189 include:

• Quality management: implementation of a documented and controlled management system.
• Staff competence: ongoing training and appropriate qualifications for all personnel.
• Method validation: scientific verification of the analytical methods used.
• Result traceability: every phase of the analytical process must be documented and verifiable.
• Safety and confidentiality: protection of sensitive data and compliance with current regulations.

Scientific and analytical approach has always been Lipinutragen’s distinctive tract. In the Lipidomic Laboratory, the Lipinutragen Team developed the Membrane Lipidomic Analysis of Mature Erythrocyte by a very accurate, repeatable and reliable analytical process, called MEM_LIP1, implementing an automated procedure through our robotic equipment, one of a kind in the world, that starts from the blood sample in EDTA performing isolation of the cell membrane of mature red blood cell and work-up ensuring the control of all operations and the best performance of the fatty acids quantification as analytical response.

In 2020, MEM_LIP1 obtained the accreditation (accreditation n. 1836L) from the Italian Accreditation Body (ACCREDIA) in accordance with the UNI CEI EN ISO / IEC 17025:2018 working in compliance with the “General requirements for the competence of testing and calibration laboratories“. This method provides the reliable fatty acid quantification of mature erythrocyte membrane, isolated from EDTA-treated human blood samples.

To view the “Certificate of Accreditation” and the characteristics of Method MEM_LIP1 connect to the following link and enter “Lipinutragen” in the laboratory name field:
>> https://services.accredia.it/accredia_labsearch.jsp?ID_LINK=1734&area=310&dipartimento=L&desc=Laboratori&