ANNUAL REPORT FOR THE YEAR 2008 (data as of )

Transcription

1 ANNUAL REPORT FOR THE YEAR 2008 (data as of ) CONTENTS 1. SINCERT members 2. Institutional bodies 3. SINCERT organisation 4. List of SINCERT assessors and experts 5. News and principal features of the year 5.1 General news 5.2 State of SINCERT accreditations 5.3 Summary of economic and financial results 6. Development of accreditation activity 6.1 Quantitative data 6.2 Development of accreditation schemes 7. Relations with stakeholders 7.1 Relations with accredited subjects 7.2 Relations with Public Administration and with various associations 7.3 Relations with enterprises and consumers 8. International collaborations and related activities 9. Cultural, promotional and communication activities 9.1 Cultural activities 9.2 Promotional and communication activities 10. Personnel, organisation and professional resources 11. Start of Accredited Conformity Assessment bodies 13. Balance sheet on 31/12/2008 Page.: 1 of 49

2 LETTER OF THE PRESIDENT FEDERICO GRAZIOLI Dear Members and Friends, April 2009 It is with pleasure that I present the SINCERT annual report of I believe it has been a particularly significant year, in terms both of achievements and from a symbolic point of view, because, following a pattern established in preceding years, it promises a historical transition for the Italian accreditation system. With the full confidence and faith that has been conferred upon me and on the Board of directors, and with the contribution of all of you, we have now reached the goal of a merger with SINAL the National System for the Accreditation of Laboratories and the creation of ACCREDIA. This represents a decisive step towards the unification of the national accreditation system in the field of accreditation and market surveillance as under Regulation number 765 of 2008 of the European Parliament and of the Council, The regulation, which becomes effective from January 1, 2010, recognises the fundamental importance of accreditation, its juridical strength and public usefulness. The regulation ensures that conformity assessment bodies guarantee the high quality of the services needed by producers and consumers. It sets out to be an essential element of control in the chain of the safe commercialisation of products, except where the role of surveillance remains under National Authorities. A considerable amount of work has been done and we will continue to give maximum effort to obtain lasting results, impressing upon the government a strong sense of responsibility in order to reciprocate the will and the acts of appointment that it will assume for the application of the standard EC framework. The basic reference for the Italian accreditation system is the European regulations, which defines National Accreditation body as The sole body in a Member State that performs accreditation with authority derived from the State. The support of some ministries who are especially interested in accreditation represents a clear signal that our activity is of increasing interest to the public. We will therefore strive to undertake accreditation activity also in the mandatory sectors, on the basis of specific tasks and on the formal initiative of competent public administrations, in full respect of the relevant laws and regulations. As regards the sector of testing laboratories in which the accreditation mark SIT is performed by a syndicated service, we have already opened contacts with the aim of establishing an agreement which permits us to meet the deadline of January 1, 2010 as Italy s sole accreditation body. We have great faith in our capacities and professionalism, with a strong track record of credibility, which we foster every day by studying new projects and assessment work. In 2008, this resulted in a qualitative and quantitative increase in terms of assessment activity, planned with precise targets in mind for a growing number of subjects. We are thus looking forward to major challenges, not least those connected to the current market global crisis of which we are very much aware; but this will not in any way influence the role of guarantor which it is our task to perform with rigorous and constant control in the conformity assessment activities. I am convinced that our beliefs and our efforts will be duly rewarded and that ACCREDIA will fully live up to expectations thanks to the work and sense of responsibility of all of you, along with all SINCERT staff and collaborators, as you have shown in the past. Page.: 2 of 49

3 1. SINCERT MEMBERS PUBLIC ADMINISTRATION, PUBLIC BODIES AND PUBLIC RESEARCH BODIES CNR Consiglio Nazionale delle Ricerche National Council of Research Consulta Regionale degli Ordini degli Ingegneri della Lombardia Regional Council of the Orders of Engineers in Lombardy ENEA Ente per le Nuove tecnologie, l Energia e l Ambiente National body of new technologies in energy and the environment INAIL Istituto Nazionale per l Assicurazione contro gli Infortuni sul Lavoro National Institution of insurance against occupational injuries Infrastrutture Lombarde Lombard Infrastructures ISPRA Istituto Superiore per la Protezione e la Ricerca Ambientale Higher Institute for Protection and Environmental Research Ministero dell Ambiente e della Tutela del Territorio e del Mare Ministry of the Environment and Maritime Protection Ministero delle Comunicazioni* - Ministry of Communication Ministero della Difesa Ministry of Defence Ministero delle Infrastrutture Ministry of Infrastructures Ministero dell Interno Ministry of Internal Affairs Ministero del Lavoro e della Previdenza Sociale Ministry of Labour and Social Welfare Ministero delle Politiche Agricole, Alimentari e Forestali Ministry of Agricultural policy, Food and Forestry Ministero dello Sviluppo Economico Ministry of Economic Development UNIONCAMERE Unione Italiana delle Camere di Commercio, Industria, Artigianato, Agricoltura Union of Italian Chambers of Commerce, Industry, Artisans and Agriculture ORGANISATIONS REPRESENTING PRODUCERS OF GOODS AND SERVICES AND OTHER OPERATORS AGIDAE Associazione Gestori Istituti Dipendenti dall Autorità Ecclesiastica Management association of Institutes depending upon Ecclesiastical Authorties AISES Associazione Italiana Segnaletica e Sicurezza - Italian association of Signing and Safety ANCE Associazione Nazionale Costruttori Edili National association of Building Constructors ANIA Associazione Nazionale fra le Imprese Assicuratrici National association of Insurance Operators CASARTIGIANI Confederazione Autonoma Sindacati Artigiani Autonomous Confederation of Artisan Unions CIA Confederazione Italiana Agricoltori Italian Confederation of Agricultural Producers CNA Confederazione Nazionale dell Artigianato e della Piccola e Media Impresa National Confederation of Artisans of Small and Medium-sized Enterprises COLDIRETTI Confederazione Nazionale dei Coltivatori Diretti National Confederation of Direct Agricultural Producers CONFAGRICOLTURA Confederazione Generale dell Agricoltura Italiana Italian General Confederation of Agriculture Page.: 3 of 49

4 CONFAPI Confederazione Italiana della Piccola e Media Industria Italian Confederation of Small and Medium-sized enterprises CONFARTIGIANATO IMPRESE Confederation of Artisan Businesses CONFCOMMERCIO Confederazione Generale del Commercio, del Turismo, dei Servizi, delle Professioni e delle Piccole Medie Imprese The General Confederation of Commerce, Tourism, Services, Professions and of Small and Medium-sized enterprises CONFESERCENTI Confederazione Italiana Esercenti Attività Commerciali, Turistiche e dei Servizi The Italian Confederation of Commercial Traders, Tourism and Services Operators CONFINDUSTRIA Confederazione Generale dell Industria Italiana The General Confederation of Italian Industry CONFINDUSTRIA SERVIZI INNOVATIVI TECNOLOGICI Confederation of Italian Industry Innovative Technological Services FEDERBIO Federazione Italiana Agricoltura Biologica e Biodinamica The Italian Federation of Organic and Biodynamic Agriculture FEDERCASA Federazione Italiana per la casa The Italian Home Federation FEDERCHIMICA The Federation of Italian Chemical Industries FINCO Federazione Industrie, Prodotti, Impianti e Servizi per le Costruzioni The Federation of Industries, Products, Plant and Services for Constructors LEGACOOP Lega Nazionale delle Cooperative e Mutue The National League of Cooperatives and Mutual associations OICE Associazione delle Organizzazioni di ingegneria, di architettura e di consulenza tecnico-economica The association of the Organisations of architecture and tecnoeconomic consultancy ASSOCIATIONS OF ACCREDITED BODIES AIOICI Associazione Italiana Organismi Indipendenti di Certificazione e Ispezione The Italian association of Independent Certification and Assessment bodies ALPI Associazione Laboratori di Prova e Organismi di Certificazione Indipendenti The association of Testing Laboratories and Independent Certfication bodies ASCOTECO Associazione per il Controllo Tecnico delle Costruzioni The association of Technical inspection of Construction FEDERAZIONE CISQ Federazione Certificazione Italiana Sistemi Qualità Aziendali The Federation of Italian Certification of Organisation Quality Systems U.N.O.A. Unione Nazionale Organismi Accreditatati The National Union of Accredited bodies ASSOCIATIONS OF CONSUMERS AND USERS, ASSOCIATIONS FOR THE PROTECTION OF THE ENVIRONMENT AND FROM RISK PROVIDERS OF PUBLIC UTILITIES OTHERS INVOLVED IN ACTIVITIES OF THE ASSOCIATION ACU Associazione Consumatori Utenti The Consumers association AIAS Associazione Professionale Italiana Ambiente e Sicurezza The Italian Professional association for the Environment and Safety APCO Associazione Professionale Italiana dei Consulenti di Direzione e Organizzazione The Italian Professional association of Management and Organisation Consultants Page.: 4 of 49

5 ASSOCONSULT Associazione Federativa delle Imprese di Consulenza Direzionale e Organizzativa The Federative association of Management and Organisation Consultancy for Enterprises ASSORECA Associazione tra le Società di Revisione e Consulenza Ambientale - The association of inspection and Environmental Consultancy Companies CON.CERTI Associazione tra Imprese di Consulenza Certificate The association of Certified Consultancy Enterprises Gruppo ENEL ENEL Distribuzione S.p.A. ENEL Group Gruppo Ferrovie dello Stato Trenitalia S.p.A. Italian State Railways The Ministry of Communications has been merged with the Ministry of Economic Development 2. INSTITUTIONAL BODIES BOARD OF DIRECTORS Federico Grazioli President Lorenzo Thione Vicepresident Daniele Colombo Giulio Del Gobbo Luciano Gaiotti Natalia Gil Lopez Manfredo Golfieri Rolando Manfredini Gianrenzo Prati Maria Teresa Ruffo Andrea Vecchia General director Filippo Trifiletti POLICY ADVISORY COMMITTEE Tommaso Campanile President PUBLIC ADMINISTRATION, PUBLIC BODIES AND PUBLIC RESEARCH BODIES Michele Candreva Enrico De Micheli Riccardo Deserti Andrea Forni Luigi Gaggeri Antonio Gambardella Fernando Giannoni Massimo Lanza Luigi Mandracchia Vincenzo Monaco Vincenzo Parrini Alessia Piccin Giuseppe Pierri Roberto Vinci Page.: 5 of 49

6 ORGANISATIONS REPRESENTING PRODUCERS OF GOODS AND SERVICES AND OTHER OPERATORS Giovanni Anselmi Angelo Artale Tommaso Buffa Tommaso Campanile Giorgio Capoccia Giancarlo Coccia Salvatore Conti Ermanno Coppola Maria Teresa Del Zoppo Gianluca Di Giulio Ettore Isacchini Nicola Massaro Gaetano Paparella Luca Pedrotti Dell Acqua Beniamino Pisano Paolo Salvan Renato Salvo Angelo Spanò Manuela Tasso Luigi Tozzi Silvia Trivini ASSOCIATIONS OF ACCREDITED BODIES Andrea Grandi Giovanni Oliveri Fabio Roversi Angelo Trapanà Rodolfo Trippodo ASSOCIATIONS OF CONSUMERS AND USERS, ASSOCIATIONS FOR THE PROTECTION OF THE ENVIRONMENT AND FROM RISK PROVIDERS OF PUBLIC UTILITIES OTHERS INVOLVED IN ACTIVITIES OF THE ASSOCIATION Franco Andretta Roberto Bandieri Giancarlo Bianchi Gianluca Cocci Marco Gentilini Antonella Lorenzini Carmine Reda Filippo Salvatori Page.: 6 of 49

7 ACCREDITATION COMMITTEE Carlo Apponi President Giuseppe Bianchi Silvano Bonelli Emilio Gatto Angiolo Geri Marina Masone Massimo Neroni Gennaro Panniello Pier Franco Rivolo Antonio Romeo Ruggero Santini Riccardo Scarsella Antonio Scipioni Paolo Soardo Giuseppe Spada Giordano Zappa BOARD OF AUDITORS Aniello Bosco President Enzo Carmine Delli Quadri Giuseppe Magliacane COLLEGE OF ARBITRATORS Eugenio Antonio Correale President Francesco Cantoni Antonio Oddo COMMISSION OF APPEAL Renato Salvo President Massimo Lanza Nicola Massaro Giuseppe Pierri Carmine Reda Roberto Vinci COMPLIANCE BODY (D.LGS. 231/01) Emanuele Montemarano President Gianni Cavinato Luigi Gaggeri* Emanuele Riva Compliance Officer *Leaving Page.: 7 of 49

8 3. SINCERT ORGANISATION MEMBERS ASSEMBLY BOARD OF ARBITRATORS BOARD OF AUDITORS COMMISSION OF APPEAL BOARD OF DIRECTORS STEERING AND CONTROL COMMITTEE COMPLIANCE BODY (D.LGS 231/01) PRESIDENT AND VICEPRESIDENT ACCREDITATION COMMITTEE SAFETY, PREVENTION AND PROTECTION GENERAL DIRECTOR CENTRAL SECRETARIAT EXTERNAL RELATIONS, COMMUNICATION AND PUBLICATIONS ADMINISTRATION OFFICE MANAGEMENT SYSTEM OFFICER TECHNICAL DIRECTOR TECHNICAL SECRETARIAT AND PROGRAMMING Hierarchical Relations Functional Relations INFORMATICS SERVICES TECHNICAL OFFICE ACCREDITATION OFFICERS ASSESSORS & EXPERTS Page.: 8 of 49

9 4. LIST OF SINCERT ASSESSORS AND EXPERTS ASSESSORS EXPERTS 1. Giordano Angle 1. Alberto Andreani 2. Paolo Biacoli ** 2. Giacomo Astengo 3. Riccardo Bianconi ** 3. Fabrizio Benedetti 4. Riccardo Bisagno 4. Ferdinando Bosoni 5. Riccardo Brolli 5. Antonio Maria Enrico Brunori 6. Maurizio Buoncompagni 6. Giovanni Carlo Fiorucci 7. Roberto Camiciottoli ** 7. Gioachino Kratter 8. Giovanni Canepa 8. Ercole Manfredi 9. Giuseppe Canepa ** 9. Marco Nava 10. Angelo Castelluccio * 10. Fabrizio Papa 11. Emilia Catto 11. Evasio Pasini 12. Mauro Cavretti * 12. Alberto Pederneschi 13. Marco Cerri ** 13. Anna Albina Sampò 14. Marco Comboni ** 14. Matteo Sbisà 15. Giacomo Conio 15. Raffaele Scialdoni 16. Giovanni Curli ** 16. Lorenzo Thione 17. Giovanni Di Falco 17. Silvia Trazzi 18. Camillo Franco 18. Bruno Zanoni 19. Francesco Frigerio ** 20. Franco Gattafoni ** 21. Nicola Gigante 22. Moreno Giordani 23. Mariagrazia Lanzanova * 24. Daniela Longo 25. Emilio Magnanti 26. Maurizio Maviglia 27. Aldo Merico 28. Tommaso Miccoli 29. Alberto Musa * 30. Daniele Pernigotti ** Page.: 9 of 49

10 31. Gianluca Qualano * 32. Emanuele Riva * 33. Francesco Santini * 34. Carla Sanz * 35. Alessandro Seno 36. Giuliano Tacchi Venturi 37. Silvia Tramontin 38. Irene Uccello * 39. Claudio Vanossi ** 40. Nobile Verratti ** 41. Giovanni Zotta * SINCERT staff or full-time collaborators ** Professional figures working full-time or mainly for SINCERT Page.: 10 of 49

11 5. NEWS, FACTS AND FIGURES FOR GENERAL NEWS SINCERT MEMBERS In 2008 FEDERCHIMICA and FINCO were admitted as members of the association. Their admission was discussed and approved by the SINCERT Members Assembly of February 21, bringing the total number of SINCERT members to 48. Also in 2008 the qualification as member was transferred from the former body, APAT - the Agency for the Protection of the Environment and for Technical Services, to the new legal body ISPRA the Higher Institute for Environmental Protection and Research. On February 21, 2008, the Members Assembly of SINCERT members approved the new General Regulations enforcing statutory provisions, ST-02 rev.02. The new regulation met the need to satisfy the requirement of impartiality, with the aim of guaranteeing fairness between all the parties involved in SINCERT activities. With the document, an organisational factor was also introduced which ensures that SINCERT conforms with the principles of ISO/IEC 17011:2004 "Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies", the standard regulating the functions of accreditation bodies, answering the need to guarantee fairness between all the parties involved which emerge from the first EA evaluation phase (April 2006). The new General Regulations divide the association into four categories (art. 11), in order to guarantee a balanced representation of the interests of SINCERT members and the integration of respective knowledge, experience and competences. The modification has had a precise aim: the enhancement of internal relations of the association with a view to full sharing of policy and strategic decisions and the activation of the best synergies for the good conduct of SINCERT activities. The new categories are: - Public administrations, Public bodies and Research bodies; - Organisations representing producers of goods and services and other operators; - associations of accredited bodies; - associations of consumers and users, associations for the protection of the environment and from risk providers of public utilities others involved in activities of the association. So as to guarantee that SINCERT adopts its own decisions with respect to fairness between Parties, avoiding the risk of any cases favouring one Party over others, an article was included whereby certain decisions taken by the Steering and Control Committee can be adopted only if approved by all the categories involved, or, failing this, by a two thirds majority of those present. Approval of the document is also closely tied to the new sole National Accreditation body. The objective of the renewal of the SINCERT Statute was based on the logical consequences of unification of the bodies by January 1, Page.: 11 of 49

12 ACCREDITATION REGULATIONS AND MARKET SURVEILLANCE The unification of the Italian accreditation system constitutes a fundamental step towards compliance with EU Regulation n. 765 of 2008, Regulation of the European Parliament and Council for the accreditation and market surveillance relating to the marketing of products, published in the Official Gazette of the EU, August 13, 2008 and applicable as from January 1, The Regulation is part of a legislative package which was drawn up under the revision of the New Approach, which also includes Decision 768 (this gives a common framework for the marketing of products) and Regulation 764 (this deals with the application of certain national technical rules to products lawfully marketed in another member State). The new Regulation: - recognises accreditation as the last level of control in the whole quality chain in both voluntary and mandatory sectors; - confers upon accreditation the legal ranking afforded by public authority undertaken in the public interest; - aims to regulate activities within the EU, strengthening rigour, effectiveness, uniformity, transparency and credibility; - endorses the methods preferred for use by Member States for the evaluation and assessment of the competence of the bodies called to evaluate conformity with the requirements of EU Directives and Regulations (notified bodies and Conformity bodies in general) as a basis for the concession of the relative authorisations and notifications by the competent national authorities; - recognises the EA as the official European accreditation infrastructure to which it entrusts the task of guaranteeing the homogeneous and effective performance of European accreditation activities. The fundamental message is that accreditation has been recognised as having a crucial role to play; that it is legally strong and in the public interest in order to ensure Conformity Assessment bodies guarantee the high quality of services they require, and for producers for the marketing of products, except in cases where surveillance remains in the ambit of national authorities. The key point for the accreditation system is that the national accreditation body is defined as The sole body that, in a Member State, performs accreditation with authority derived from the State. The need to unify the Italian accreditation bodies, SINAL, SINCERT and SIT, has thus become of increasing importance. The process began some time ago, also through the intensification of the activities of FIDEA, the Italian Federation of Accreditation bodies, and this necessity has entered its final phase in The merger of SINCERT with SINAL is scheduled to be completed by mid 2009 in order to give full value to respective experience of competences, professionalism and procedures. In brief, the sector of testing laboratories and that of certification and inspection bodies will be integrated in the new structure in a shared vision and with shared management so as to meet EU objectives, but without compromising the expectations and interests of businesses, consumers and other operators with a view to consolidating quality and safety objectives. Page.: 12 of 49

13 GENERAL REGULATIONS The programme of revising the SINCERT General Regulations, begun in 2007, for greater efficiency and effectiveness in accreditation management and continued in 2008 to comply with modifications introduced by the General Regulations enforcing statutory provisions ST-02, rev. 2, regarded the Steering and Control Committee rules of procedure RG-09, revision 01, and the Commission of Appeal Rules of Procedure, also now at revision 01. The revision has begun of the Accreditation Committee Rules of Procedure RG-08, which became necessary for updating the Annex with names and CVs of new members. Also under revision are the Regulations for the Accreditation of Certification bodies and the Regulation for the Accreditation of inspection bodies (RG-01 rev. 02 and RG-03, rev. 02), where certain items are placed in comparison with associations of Accredited bodies. There are very important possibilities of modification regarding the performance at short notice of scheduled and extraordinary surveillance at certified/assessed subjects with bodies that have issued conformity assessment reports. Also of importance is the proposal to increase the volume of surveillance evaluation conformity assessment activity wherever the certification concerns mandatory items (such as the QMS, building sector EA 28); the assessment of closure and of the effectiveness of all findings (NCs and observations) before granting accreditation or extension thereof; the possibility of intervening where there is evidence that the bodies have offered their services at excessively low rates or that they have paid their auditors fees outside market norms. EA AUDIT From March 17 to 19 EA undertook an evaluation of SINCERT to verify the SINCERT s continuing conformity with EA MLA requirements the object of which was to evaluate the effectiveness of corrective actions put in place following the findings formalised at the output of the first phase of evaluation in April, The EA Evaluation consisted of an audit at SINCERT and of an observation of a witness audit carried out by SINCERT at the premises of two accredited certification bodies. These involved the quality and environmental management systems and product schemes, in one case, and the inspection scheme in the other. The EA team found that the two audits were conducted in a totally satisfactory manner. The SINCERT audit groups showed high competence and professionalism and were found to be in perfect compliance with the applicable standards. SINCERT showed that it had put properly in place the corrective actions undertaken following the findings formalised at output of the first phase of evaluation in April, The final report was decidedly positive, and the new findings, which consisted of three observations and one comment, were accepted by the Direction as keys for improvement and confirmation of the commitment of the body to fairness and thoroughness in its work, in a spirit of full collaboration with the European body. The report will soon be subjected to the EA MAC committee which will issue a final decision of the confirmation of SINCERT s status as EA MLA signatory. Page.: 13 of 49

14 THE CRIME PREVENTION SYSTEM The process of adjustment to D.Lgs. June 8, 2001, n. 231 has been concluded - Regulation of administrative responsibilities of juridical persons, of organisations and associations also not possessing juridical persons, in compliance with article 11 of the Act of September 29, 2000, n. 300, which, together with other initiatives, moves towards updating and directing SINCERT activities always further towards the qualification of the entire conformity assessment system. With the aim of exonerating SINCERT from any responsibilities in cases where crimes are committed under D.Lgs. 231, a model of organisation, management and control has been developed. In 2007 a risk analysis was conducted and the documents resulting from such were presented in order to integrate the crime prevention system in observance of D.Lgs. 231 with the already existing SINCERT management system in compliance with ISO/IEC In 2008 the Model of organisation for Management and Control RG-11 and the Code of Ethics and Behaviour RG-12 were both adopted. An internal Compliance body was instituted (coming under the Regulation of the Functioning of the Compliance body RG-13) with the task of monitoring compliance, effectiveness and adequacy of the organisational model by all subjects involved in the management and in the activities of the body, including all staff and collaborators and also members of association structures and suppliers. The body, consisting of four members, among whom one President and one Compliance Officer, focused its attention on the definition of rules and the implementations necessary for diffusion of information to all interested parties, of Organisational Model D.Lgs. 231, prepared by SINCERT. The operative phase concerned the analysis of audits conducted for evaluating, above all, adherence to the Code of Ethics and Behaviour, and thus the pertinent procedures and support instructions. The audit covered areas of Privacy, Security, Safety and Administration and it will continue in 2009 in these and other areas including Complaints Management and Direction. All the audits hitherto performed have confirmed SINCERT compliance with the mandatory provisions pursuant to D.Lgs 231, resulting in certain recommendations which have all been taken on board by the SINCERT Direction. INTERNAL SAFETY The adjustment has been made to comply with D.Lgs, April9, 2008, n. 81, Safety Text, fulfilling all the necessary compliances. These are the updating of the risk evaluation document, enquiries in industry regarding the exposure to chemical substances at places of work and technical inspections to evaluate the maintenance of building structures. The internal safety plan was completed after a series of interventions of training for all internal and collaboration staff, with specific initiatives in support of directors and other people with expert knowledge of fire risks and first aid. SINCERT Assessors and Experts have also been given a badge and they have been trained in the use of individual articles of protection. Page.: 14 of 49

15 COLLABORATION WITH INSTITUTIONS In September 2008 a Memorandum of Understanding was signed with the CNCU The National Council of Consumers by the SINCERT President (in his role as President of the CNCU) and by the Ministry of Economic Development. The primary objective is to promote confidence in the products and services in compliance with national and international technical standards in matters concerning quality and safety which have received accreditation audit. Under the MoU, the two bodies have begun to operate, with the involvement of all public and private stakeholders in the interests of co-operation between legislation and voluntary standards and between notification and voluntary accreditation, developing initiatives joining information and training with members of consumer associations. In 2009 plans have been made for discussion events which will be open to the public, such as congresses, workshops and forums. These will enhance synergies of the respective flows of communication as instruments for the exchange of knowledge. The objective has high priority both for the institutions and for the consumers, complying with the requirements of the Consumer Code (D.Lgs. 206/05 articles 136 et seq.), into which the institutional law of the CNCU (L. 281/98) has been incorporated. An important point regards SINCERT s commitment to continue to follow, with all necessary vigour, feedbacks pointing out irregularity or inadequacy in its own work and in accredited subjects, highlighting audit results and the adoption of corrective actions where necessary. In order to further this drive, a section for feedbacks and complaints has been introduced on the website. Collaboration with UNI has continued on the basis of the MoU signed in December, This strengthened relations with the Italian system for standardization, represented also by the Committee of Assessors and Experts. The activity of analysis of SINCERT Technical Regulations also took place, to highlight contents which could become standards, comparing them and integrating them with UNI documents which already cover the topic. The revision has also begun of such Regulations, taking care of the emerging market trends. A linked programme of information/training has also begun. It regards the entire socio-economic context of reference (conformity assessment operators as well as enterprises, institutions and consumers), and it is fully discussed in the paragraph Promotional and communications activities. OTHER SALIENT FACTS In 2008 the Commission of Appeal dealt with three appeals, all of which were promptly and carefully handled. This confirmed the decisions taken by the Accreditation Committee, demonstrating the transparency of decision-making processes which guarantee to all interested parties that non-conformities are rigorously brought to light and, where necessary, corrected. The Commission also initiated the examination of two other complaints which were received at the end of With a view to optimising coordinated activities of the FIDEA federation and with a view to strengthening relations with Public Administrations, a SINCERT office was opened in Rome, at the offices of SINAL. Page.: 15 of 49

16 5.2 STATE OF SINCERT ACCREDITATIONS Accreditation activities are summarised as follows. ACCREDITATION OF CERTIFICATION AND INSPECTION BODIES The number of operative certification and inspection bodies holding SINCERT accreditation passed from 125 (December 31, 2007) to 129 an increase of 3%. The total number of body accreditations passes from 226 (December 31, 2007) to 238, an increase of 5%. Nine new Subjects have been accredited: ANAS Spa, Autostrade per l Italia, (Italian motorways) C.C.Q.A.A., CERTIEURO Srl, ENAMA, GCS Srl, ICOVER Srl, MERCURIO Ingegneria Spa e S.C. AllCERT SYSTEMS Srl after two accreditations revoked ERGOCERT Srl e ISRANDT-ISRACERT Division, after two accreditation renounces PMIcert Srl e O.T.A. Srl and the merger of two Certification bodies in one accredited Subject. The breakdown of accreditations on December 31, 2008 is reported below, along with last year s figures. Accreditation scheme QMS EMS OHSMS ISMS FMS PRD PRS ISP EPD QMS - Quality Management System (ISO 9001) EMS Environmental Management System (ISO 14001) OHSMS Occupational Health and Safety Management System ( [BS] OHSAS 18001) ISMS Information Security Management System (ISO 27001) FMS Food Management System (ISO 22000) PRD - Products/Services PRS - Personnel ISP inspection EPD Environmental Product Declaration (UNI ISO 14025) The number of management systems certifications (productive sites), issued under SINCERT accreditation at is distributed as follows: - QMS (ISO 9001:2000 and ISO 9001:2008): QMS (other quality standards: AVSQ MIA, EN 9100:2005, ISO 13485:2004, ISO 3834:2006, etc.): EMS (ISO 14001:2004): OHSMS (OHSAS 18001:1999 and OHSAS 18001:2007): ISMS (ISO 27001:2005): 235 Page.: 16 of 49

17 The total number of management systems (productive site) certifications, accredited by SINCERT, at , stood at over 134,200 Some 50,000 of these are products (devices and consumption goods, long-lasting and shortlasting), with a steady and significant increase in the agriculture and food production sector. For a few years now, some service certification schemes, such as training services, compliance services and relations with organisations have all been accredited. inspection activities under SINCERT accreditation are constantly on the rise. Accreditation scopes cover numerous sectors, amongst which: - buildings; including project audits for verification and technical compliance audits during construction for the granting of ten-year insurance policies; - food and agriculture products and processes; - industrial products and processes; - plastic materials; - fuel distribution services; - hotel and restaurant services; - public transport services; - rail infrastructures; - road infrastructures. Many professional figures also come under SINCERT accreditation, including management systems auditors, project planners, consultants and management systems officers (about 1,400) who operate in the quality sector, as well as other figures who are active in specific sectors tied to construction and quality assurance processes, welders welding operators, professional welders, non destructive testing personnel, cathodic protection personnel, etc. or new professional figures in the health sector. All this for a total of over 80,000 certified people. The growth, of around 3%, in management systems certification, reflects a slowdown with respect to (when the growth was of 10%) and compared with previous years. This reflects a pause in growth or even a decline in a market which is in some areas saturated, and it also reflects the global financial crisis which has cut deeply into the economy. The difficulties created by this situation for many organisations can have consequences on the volume of activity of the competent certification and inspection bodies. However, this will not have any negative influence upon methods and operative practices which SINCERT will continue to control, confident in the system which guarantees a role for the system of conformity assessment. The Accreditation body also confirms its consolidated financial solidity. RECOGNITION OF BODIES OPERATING UNDER ACCREDITATION OF OTHER EA MLA ACCREDITATION (QMS SCHEME, BUILDING SECTOR EA 28) The activity has continued of recognition of bodies operating under other EA MLA accreditations for the issuing of QMSs in building sector EA 28, pursuant to the Decision of the Authority for the supervision of Public Contracts for works, services and supplies Public Contracts N. 11/2003 of May 14, 2003 and successive amendments. Page.: 17 of 49

18 The state of recognition of these bodies is published in a SINCERT list which is regularly updated and published on the website LS-08, List of Certification bodies recognized by SINCERT for the issuing certificates of Certification of conformity to the Standard ISO 9001:2000 (SINCERT document RT-05), for use within the qualification system of building firms (sector EA 28), according to of the Decision of the Authority for the supervision of Public Contracts for works, services and supplies N.11/2003 of 14 May The list can be consulted in interactive form in the section Lists and Data Banks on the website, through the database of foreign bodies recognised for sector EA 28. At December 31, 2008, under SINCERT accreditation in sector EA 28 (full or with limitations) there are 56 bodies, an increase of two for the same period of Operating under foreign bodies accreditation, signatories to the EA MLA Agreements and recognised by SINCERT: - 15 bodies (an increase of 4 on 2007) through direct agreement, - 25 bodies (one more than 2007) through Agreement Protocols stipulated with the respective accreditation bodies, for a total of 40 recognised bodies, representing an increase of 14%. These recognitions commit SINCERT to an initial conformity assessment under the requirements of the Technical Regulations applicable in a diligent and constant evaluation activity, through on-site and witness audits. Altogether, the number of bodies operating under SINCERT accreditation for sector EA 28 corresponds to 96 subjects (of which 56 accredited bodies), which is 7 more than the same period of 2007, constituting a total increase of almost 8%. 5.3 SUMMARY OF ECONOMIC AND FINANCIAL RESULTS The Balance at closes with a positive result before taxation, equivalent to circa 517,000 (4,5% above the results for 2007 for reasons given below) and with a post-tax result of circa which is 20% above the 2007 result. Thanks to new legislation which has reduced the fiscal load, the taxable income, despite the gross increase, has gone down by some 41,000. The most important features of economic and financial management can be summarised as follows: Profit and Loss Statement see also the statement attached to this Report: - As per the current tariffs, the revenue for accreditation activity, revenue for accreditation activity (excluding assessors expenses) increased by about 5.25%, with an increase of 4.75% for revenue from registration inscription rights (related to the turnover of accredited Subjects) and of 5.75% for evaluation activities (examination of documents, on-site and witness audits and applications for new accreditation). It is important to notice that SINCERT s tariffs have not altered for some years (the last, and relatively minor changes were made in 2002, when the Euro was introduced). The situation regarding revenue from registration inscription rights reveals a steady slowdown in the rate of increase: from a 13% rise in 2005 to an 8% rise in 2006 and a 7.7% rise in This figure is more stable with respect to the figure related to assessment activity: %; this confirms the effort made in 2008 in terms of audits of accredited subjects, Page.: 18 of 49

19 especially in scheduled and extraordinary surveillance. The trend of revenues indicates, moreover, that the turnover of accredited bodies maintained a positive growth rate, despite the market saturation of management systems. - Proceeds from project development posted a considerable growth compared with 2007: + 24,000, following the agreement of technical collaboration with the Irish accreditation body for which a SINCERT officer has been working in Ireland starting from October The total value of production has grown by about 6%. - Production costs have increased as per expectations, at a rate of 6.5%, in line with association income. The greatest differences have occurred in the increase in personnel expenses following the formal appointment of a General Director and the reduction of expenses due to institutional bodies, as well as the reduction of expenses paid for international activities undertaken with regard to EA. As in previous years, personnel expenses include a bonus which is equivalent to one month s salary. Balance (see also the Balance Analysis Schedules): - Credits for organisations are greater than debts, these being debts of suppliers, fiscal debts, debts owed to welfare organisations and others; - Financial resources are ample. The body has indeed considerably improved revenue across the board. The increase in liquidity in the associations bank account stands at 802,202 and this is also is due to the non-renewal of investments after their expiry; this has lead to a greater belief in retaining finances in bank accounts, for which conditions are more advantageous. This policy is a result of the global financial crisis which has led to a reduction of revenue from state equity; - Reserve capital, together with available capital, amounting to 2,197,902 constitute a credible guarantee of the association s financial strength. This is clearly crucial for the autonomy and independence of the body and in matters concerning the creation of a Sole Italian accreditation body and all projects thereby connected. Page.: 19 of 49

20 6. DEVELOPMENT OF ACCREDITATION ACTIVITIES 6.1 DATA AND FIGURES As described in paragraph 5.2, SINCERT accreditations have shown a steady upward trend throughout 2008, posting stronger rises than ever before. The table shows the main data related to assessment activities performed by SINCERT in year year Assessment activities Number of on-site audits Number of witness audits Number of document audits Total On-site audits (in man-days) Accreditation Surveillance Supplementary ,5 Extraordinary 2 8 Witness audits (in man-days) Accreditation 67 66,5 Surveillance 594,5 611 Extension 168,5 156 Supplementary 31 29,5 Extraordinary 24 8 Document Audits (in man-days) ,5 Total assessment activities (in man-days) As can be seen, in 2008 assessment activity was greater than it was in 2007, showing a 6% rise in audit numbers and a corresponding 4.2% rise in the total of man-days for assessment. Compared with 2007, on-site audits were the most numerous up by 9.8%, with a corresponding rise in man-days taken up by audit activity which was up by 11%. The highest number of audits were on-site first accreditation audits, up by 16%, but the greatest percentage rise came from accreditation surveillance audits which increased by 17.5%. There was, however, a considerable decline in on-site supplementary audits (down 35%) to be set against a surge of extraordinary audits resulting from feedbacks and complaints which were up by 300% Page.: 20 of 49

21 Concerning the number of witness audits, the figure grew by 3% along with a slight reduction in the corresponding number of man-days, which was down 1.6%. Witness audit activity showing an increase in man-days for surveillance audits was up 3%; special audits were down 66 %, supplementary audits showed a 5% decline while witness extension audits were also down, by 8%. Setting aside the above results, 115 files were presented to the Accreditation Committee, 40% of which were for existing accreditation extensions; 38% for accreditation renewal of certification/assessment bodies and 16% for new accreditations. To this figure must be added about 100 files for the transition to new editions of standards for bodies providing audits and certification using different schemes (UNI CEI EN ISO/IEC 17021:2006, BS OHSAS ; ISO/IEC 27006:2007) and numerous files regarding ownership transfer of accreditation to new bodies. For activities related to sanctions, (suspensions and withdrawals from accreditation), see 7.1 Relations with accredited subjects. 6.2 THE DEVELOPMENT OF ACCREDITATION SCHEMES On September 15, 2008, the two-year transition period expired for the application of standard ISO/IEC as fixed by EA/IAF/ISO, Conformity assessment Requirements for bodies providing audit and certification of management systems, which defines requirements for bodies carrying out certification of management systems (QMS, EMS, OHSAS, ISMS, FMS, etc.), with a view to the definitive substitution of ISO/IEC Guide 62, (EN 45012) and the ISO/IEC Guide 66. The transitory period was one of intense work for the SINCERT technical staff who were planning and performing audits under the new standard and inserting them into the process of accreditation, surveillance and renewal of management system certification bodies starting from June At the deadline, adjustment to ISO/IEC 17021:2006 had been positively concluded for 71 management system certification bodies out of a total of 75. For three bodies (one of which was already suspended) the Accreditation Committee decided on a suspension of 6 months. The result reflected the commitment shown by all the bodies. A new method of presenting files has been introduced into the Accreditation Committee. It is an experiment which began with the March session and became fully adopted thereafter. This was also done with a view to the harmonisation of procedures with SINAL for the sole accreditation body. Individual members of the Committee are selected as reference persons for schemes and/or sectors and they perform a role of person of reference for the files. It has proved to be a useful step both in terms of speeding up the examination of the many files put before the Committee and also for dealing better with single critical aspects by means of a comparative analysis conducted by SINCERT staff (Technical Director or Accreditation Officer). Monitoring the performance of SINCERT assessors has continued. It began in 2007 with a three-year plan for revising reports in terms of clarity and adequacy of findings (annual audit). Page.: 21 of 49

22 Research and development activity to improve accreditation schemes, for the introduction of new schemes and the improvement of existing ones continues to be undertaken by the SINCERT Working Groups. The involvement of all interested parties, represented in a fair and balanced manner, guarantees the impartiality of their work and the constant perception of the needs of the frameworks of reference. It is therefore clear that Working Groups perform a crucial task in responding to quality requests coming from stakeholders and the market with ever-increasing effectiveness. Working Groups include as experts in the object scheme and are co-ordinated, in general, by a SINCERT technical officer. They are normally open to one member for each conformity assessment body subjects accredited in the scheme or those who have applied for accreditation, and to representatives of interested parties who have specific competences regarding the scheme and who represent general economic and common interests. The documents of the Working Group are regularly updated in special sections for this on SINCERT s website. QMS SCHEME QUALITY MANAGEMENT SYSTEMS (ISO 9001:2000) The scheme for the accreditation of certifications of the quality management system as under ISO standard 9001:2000 (and ISO 9001:2008) covers 33% of accreditations granted, with 75 certification bodies operating for the granting of the corresponding conformity assessments. The number is the same as it was in 2007, given that for new accreditations there was the same number of withdrawals and suspensions. The most important novelty regards the ISO and IAF rules for the transition from certification standard ISO 9001:2000 to standard ISO 9001:2008. The international ISO standard was published on November 15, 2008 to be adopted as UNI EN ISO 9001:2008 on November 26, SINCERT complied with the ISO and IAF rules which were agreed in an implementation plan to ensure the smooth process of implementation of accredited certifications, as in ISO/IAF communication Implementation of accredited certification to ISO 9001:2008 and document ISO/TC176/SC 2/N836 Implementation Guidance for ISO 9001:2008, both to be found on SINCERT s website. In particular, SINCERT has already begun to check the implementation of the specific adjustments during the performance of on-site compliance audits as a part of the plan for the maintenance of the QMS accreditation scheme. Following the results of the above process, during 2009 SINCERT will update all relevant accreditation documents (Certificates and Annexes) with the new reference to standard ISO 9001:2008. The transition period expires November 15, 2010, from which date onwards ISO 9001:2000 certifications will no longer be valid. With the aim of optimising processes which the bodies must follow, SINCERT, autonomously and in collaboration with UNI, has embarked on a formation plan of training sessions, including preparation of the relevant documents, (see Cultural Activities). Page.: 22 of 49

23 Work carried out by the Group Medical Devices has been concluded. In March, 2008, this led to the revision of Technical Regulation RT-20, Rules for the accreditation of QMS certification bodies for the sector of medical devices, now in its second revision. The modifications regard the updating of reference standards applicable to the certification of such systems, today defined in the single standard ISO 13485:2004. In particular, the new regulation took into consideration the recommendations expressed in the EA that quality management system certifications in conformity with standard ISO 13485:2004 cannot be granted to organisations selling medical devices. Work has continued on the forum of analysis with the associations of Accredited Subjects, begun in 2007 to study the situation of the QMS certifications regarding the suppliers of the large organisations: big enterprises, industrial groups and public utilities (transport, telecommunications, energy etc). The meetings have been formally codified as Working Groups. They have led to a better understanding of critical factors which potentially influence the use of products and services which have been certified by these large organisations. They have special needs which are determined by the nature of the service they offer, by the high volume of purchase activity, by the complexities of suppliers selection and the ability to control the actual chain of supply which necessarily reflects a high degree of faith in their suppliers, also because the market authorities impose strict controls on all details of the services they perform. The intention is not to define an ad hoc accreditation scheme but rather to analyse in depth various cases of inadequacy and thereby to reinforce the value and credibility of ISO 9001 certifications because they are commonly used by such organisations. EMS SCHEME ENVIRONMENTAL MANAGEMENT SYSTEM (ISO 14001) The scheme is in constant growth and currently covers 16% of all ongoing SINCERT accreditations, with 36 operative bodies an increase of two on The Working Group Environment met regularly, and, with the contribution of representatives of the Parties involved in the environmental question, it is always involved in the discussion of problems related to the certification scheme, studying critical cases, occasionally commissioned by the SINCERT accreditation committee, and the preparation of support documents for assessment activities. From the beginning of the year the Technical Regulation RT-09 became applicable: Rules for the accreditation of bodies operating EMS certifications published in December 2007 in revision 3 which updates the part Rules for certification under UNI EN ISO in sector EA 36 with reference to Public Administrations with territorial competences. In 2008 SINCERT began a process of scope verification of certificates ISO 14001:2004 granted by Public Administrations with territorial competences (Local government, Provincial authorities, park management authorities etc.) certified by accreditation bodies. The process aims to ascertain if there are any certificates in violation of the RT-09 rules, 12.9 (no activity can be excluded from the application filed of the EMS certificate, with the sole exception of certain types of public administration. With the intention of drawing attention to the role of Public in its relations with the accreditation system, a study group was instituted within the Environment working group, also resulting from the increasing involvement of local authorities in environmental certification for territory management. Page.: 23 of 49