The significance of accreditation
Accreditation consists in the official recognition of the suitability and conformity of a laboratory to carry out specific tests or certain types of tests. Article n. 12 of Law n. 132/2016 concerns the “National network of accredited laboratories“, adapted to the UNI CEI EN ISO/IEC 17025 standard, states the general requirements of competence, independence, impartiality and the regular and consistent functioning of testing laboratories.
Each country in Europe must nominate its own unique accreditation body connected to the international networks of Accreditation Bodies,
in according to the European Regulation 765/2008. ACCREDIA, is the Italian accreditation body certifying the competence, independence and impartiality of bodies certification, inspection, verification, and testing and calibration laboratories.
The accreditation bodies, independent and representative of all interested parties, guarantee users, about the competence, independence and impartiality of accredited testing laboratories in carrying out the required analysis, through specific technical checks and inspections. Testing laboratories are accredited for each single test subjected to accreditation bodies control, and not for the entire laboratory analytical activities.
The difference between ISO/IEC 17025 accreditation and ISO 9001 certification for testing and calibration laboratories
The accredited testing and calibration laboratories guarantee the reliability of the results provided, precisely by virtue of accreditation. In this sense, the difference between the ISO 9001 certification of the laboratory’s quality management system – issued by a certification body – and the ISO / IEC 17025 accreditation of the laboratory itself – issued by a national accreditation body – is crucial.
The accreditation process involves technical inspectors, provides to conduct an accurate assessment of all the elements that invalidate the production of technical data, including:
- Technical competence of the staff
- Validity and suitability of the applied methods
- Metrological traceability of measurements and calibrations (international system (SI) of units of measurement)
- Appropriate application of Measurement Uncertainty
- Suitability, calibration and maintenance of test equipment
- Environmental conditions in which the tests take place
- Sampling, management and transportation of test objects (samples)
- Quality assurance of test and calibration data.
Ultimately, ISO / IEC 17025 requires that the management system complies with the principles of the ISO 9001 standard. Being in compliance with the requirements of ISO / IEC 17025 therefore means that the laboratory meets both the technical and management system requirements necessary to offer technically reliable results.
The certification of a laboratory according to ISO 9001 checks by an accredited body and the accreditation according to ISO / IEC 17025 confer trust in the services of the laboratory itself, but they are not the same thing. The ISO 9001 certification does not demonstrate the evidence that the laboratory is competent of providing accurate and reliable results. To be so, the laboratory must be accredited in accordance with ISO / IEC 17025.
MEM_LIP1 analytical procedure
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.
The accreditation process of the Lipidomic Laboratory
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.