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ACCREDIA

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ACCREDIA
NameACCREDIA
Native nameEnte Italiano di Accreditamento
Formation2009
HeadquartersRome, Italy
Region servedItaly
Leader titlePresident
Leader nameBruno Sain
Websiteaccreditamento.it

ACCREDIA ACCREDIA is the Italian national accreditation body responsible for certifying competence of conformity assessment bodies in Italy. It operates within a network including European Committee for Standardization, International Organization for Standardization, International Electrotechnical Commission, European Cooperation for Accreditation, European Commission and interfaces with regulatory authorities such as Minister of Economic Development (Italy), Ministry of Health (Italy), Istituto Superiore di Sanità, Agenzia Italiana del Farmaco, Italian Civil Protection Department.

History

ACCREDIA was established in 2009 through merger and reorganization processes influenced by earlier entities like SINAL, SINCERT, SINAL-SINCERT merger, and national reforms following European directives such as Directive 98/79/EC and Regulation (EU) 765/2008. Its evolution reflects interactions with supranational bodies including European Commission, European Cooperation for Accreditation, International Laboratory Accreditation Cooperation, and regulatory cases involving European Food Safety Authority, European Medicines Agency, Council of the European Union. Historical predecessors engaged with standards from ISO/IEC 17025, ISO 15189, ISO 9001, and oversight by institutions such as Autorità Garante della Concorrenza e del Mercato.

Functions and Responsibilities

ACCREDIA performs accreditation of conformity assessment bodies including testing laboratories, calibration laboratories, certification bodies, inspection bodies, proficiency testing providers under international standards like ISO/IEC 17020, ISO/IEC 17021, ISO/IEC 17024. It issues accreditation certificates relied upon by regulators including Ministry of Health (Italy), Ministry of Economic Development (Italy), European Commission, World Health Organization and commercial stakeholders including Unioncamere, Confindustria, European Bank for Reconstruction and Development. ACCREDIA also maintains registers used by entities such as Italian National Firefighters Corps, Italian Post, ENAV and supports conformity marking schemes related to CE marking and directives like Machinery Directive 2006/42/EC.

Organizational Structure

ACCREDIA's governance includes a Board of Directors, a President, and technical committees with expert panels drawing members from institutions such as Istituto Nazionale di Statistica (ISTAT), Istituto Nazionale di Ricerca Metrologica (INRIM), Istituto Superiore di Sanità, University of Rome La Sapienza, Politecnico di Milano and representatives from trade associations including Federchimica, Confindustria, Confartigianato. Advisory bodies coordinate with international networks like European Accreditation (EA), International Laboratory Accreditation Cooperation (ILAC), International Accreditation Forum (IAF). Operational units administer accreditation schemes, technical assessments, legal affairs and quality management interfacing with Autorità per le Garanzie nelle Comunicazioni, Garante per la Protezione dei Dati Personali, Camera dei Deputati, Senate of the Republic (Italy).

Accreditation Programmes and Standards

ACCREDIA implements programmes based on international and European standards such as ISO/IEC 17025, ISO 15189, ISO/IEC 17021-1, ISO/IEC 17024, ISO/IEC 17020, and sector-specific schemes referencing directives like In Vitro Diagnostic Regulation (EU) 2017/746, Medical Devices Regulation (EU) 2017/745, Regulation (EC) No 765/2008. Accredited areas include chemical testing used by ENI, Edison S.p.A., Saipem; food safety laboratories linked to Barilla Group, Parmalat; environmental assessments involving ARPA (regional agencies), and metrology services aligned with EURAMET, BIPM and national laboratories such as INRIM. Certification schemes interact with standards bodies like UNI (Italian Organisation for Standardization), CEN, CENELEC.

International Relations and Memberships

ACCREDIA is a signatory to multilateral recognition arrangements with International Laboratory Accreditation Cooperation (ILAC), International Accreditation Forum (IAF), and active in European Cooperation for Accreditation (EA), International Organization for Standardization (ISO), International Electrotechnical Commission (IEC). It represents Italy in negotiations with European Commission, World Trade Organization, Organisation for Economic Co-operation and Development (OECD), and cooperates on projects with World Health Organization, Codex Alimentarius Commission, European Food Safety Authority (EFSA), European Medicines Agency (EMA). Bilateral technical cooperation agreements exist with national bodies such as UKAS, DAkkS, COFRAC, ENAC (Spain), RvA (Netherlands), JAB (Japan), CNAS (China).

ACCREDIA operates under Italian law frameworks including provisions stemming from Legislative Decree 93/2000, Regulation (EC) No 765/2008, and national decrees relating to accreditation and market surveillance cooperating with authorities such as Ministry of Economic Development (Italy), Italian Competition Authority, Ministry of Health (Italy). Its legal status and public tasks align with administrative procedures involving Council of State (Italy), Court of Auditors (Italy), and compliance with European case law from the Court of Justice of the European Union. Internal governance is subject to transparency obligations interacting with Anticorruzione frameworks and audit oversight by entities like Corte dei conti.

Controversies and Criticism

ACCREDIA has faced scrutiny in public debates involving disputes with certified bodies, sectoral stakeholders such as pharmaceutical companies including Menarini, Chiesi Farmaceutici, and controversies over accreditation decisions affecting producers like Ferrero and regional authorities including Regione Lombardia. Criticisms have emerged in parliamentary inquiries led by committees of the Chamber of Deputies (Italy) and Senate of the Republic (Italy) regarding transparency, timeliness of assessments, and alignment with European Commission policy. Stakeholder disputes have involved professional associations such as Federazione degli Ordini dei Medici and consumer groups like Federconsumatori.

Category:Accreditation bodies