Certification - Quality System
Approval under Articles 1 and 2 of the Ministerial Decree of March 19, 1998
AAT has obtained an approval for the analysis of biological samples derived from clinical trials of medicinal products within the meaning of the Articles 1 and 2 of D.M. March 19, 1998 (Certificate issued by the AUSL of Piacenza on 17/05/2011, protocol N. 23606).
AIFA (Italian Drug Agency) included AAT in the register OsSC of private laboratories carrying out microbiological analysis of biological samples derived from clinical trials of medicines in accordance with the Articles 1 and 2 of this Decree (No. AIFA.RSC/58605/P communication AIFA 01/06/2011).
The register is currently not available due to problems of internal reorganization of AIFA, as declared at site: www.agenziafarmaco.gov.it
Regional recognition for the internal control for food companies
The Laboratory has been included in the List of Regional Laboratories that perform analyses in the context of the internal control procedures of food companies in the Emilia Romagna Region, Directorate General for Health and Social Welfare, Veterinary and Food Hygiene. The registration number is: 008/PC/005 of 17 October 2012.
This list is updated once a semester and is available at: www.alimenti-salute.it
Accreditation in compliance with UNI CEI EN ISO / IEC 17025:2005
The Laboratory of AAT is accredited in accordance with the requirements of the UNI CEI EN ISO / IEC 17025:2005 "General requirements for the competence of testing and calibration laboratories".
Between ACCREDIA and AAT there is a contract that can be viewed at the Laboratory upon request from the Customer. The mark or reference to accreditation should not be used by Clients in the documentation concerning a product, unless it is accompanied by a copy of the test report.
Being in accordance with the provisions of the ISO 17025 norm means to possess the technical expertise to carry out the analysis, a system of quality management, essential to ensure the accuracy of the analytical data, to guarantee the traceability of measurements and the compliance of own expertise to the international regulatory requirements as well as to the mandatory legislative requirements.
The Italian accreditation body ACCREDIA, through the results of its inspections at the Laboratory and sample checks on the tests , ensures that the Laboratory is able to perform the accredited tests as required by the relevant standards and methods test.
The international accreditation system has put into place external control mechanisms whereby accreditation bodies join international organisations.
Accreditation bodies which are EA members have the possibility of becoming signatories of the Multilateral Agreements (MLA) only after successfully undergoing a thorough peer assessment.
ACCREDIA's participation in the Multilateral Agreements is a guarantee of competence and procedural rigor and also of operative uniformity with regard to other signatory bodies.
International agreements ensure the validity and credibility of accreditation as an effective instrument of qualification of operators of conformity assessment on the European and world market.
Recognition of the equivalence of accreditation activities undertaken by all members who are signatory to the accreditation system managed by IAF-ILAC internationally and by EA on a regional European level.
By virtue of this participation, testing and inspection activities, as well as certification of products, systems and personnel, issued under ACCREDIA accreditation, are both recognized and accepted internationally.
International agreements of mutual recognition eliminate the necessity of additional conformity evaluation for accredited goods, services or persons in any signatory European country.
Number of Accreditation of AAT Laboratory : 1357
Date of first accreditation : 22/05/2013.
The validity of accreditation and the list of accredited tests can be found at the following link:www.accredia.it