1. ACCREDITATION PROCESS AND THE BENEFITS OF ACCREDITATION dr. Tina Pirš, dr. vet. med. Quality Manager, Veterinary Faculty, Slovenia

5. What is accreditation? Accreditation: third-party recognition of technical competence and integrity of organisation to perform specific tasks. „attestation by a national accreditation body that a conformity assesment body meets the requirements set by harmonised standards and, where applicable, any additional requirement including those set out in relevant sectoral schemes, to carry out a specific conformity assesment activity.“ Attestation is "issue of a statement, based on a decision following review, that fulfilment of specified requirements has been demonstrated".

6. Accreditations in the EU Legal framework for the provision of accreditation services: Regulation (EC) No. 765/2008 on the requirements for accreditation and market surveillance: rules apply to regulatory and non-regulated (voluntary) sectors used as from 1st Jan 2010 The Commission recognized the European Cooperation for Accreditation (EA) - together with the European Free Trade Association (EFTA) - as the official accreditation infrastructure in Europe, which includes the national accreditation bodies.

7. Accreditations in the EU The European co-operation for Accreditation (EA) has been appointed responsible for managing the peer assessment of national accreditation bodies. Enables evaluation of NABs and mutual acceptance of conformity certificates (within EU and beyond) The objective of the Regulation: to ensure that a single accreditation certificate would suffice for the entire EU territory, and to prevent the existence of multiple accreditations.

8. MLA (BLA ) EA Multilateral Agreement (EA MLA): signed agreement between the EA Full Members. The signatories recognise and accept the equivalence of the accreditation systems operated by the signing members, and the reliability of the conformity assessment results provided by conformity assessment bodies accredited by the signing members. Bilateral Agreement (BLA): between an EA Associate Member and EA (the same purpose, the same requirements).

9. Structures – global accreditation recognition European Accreditation ILAC - International Laboratory Accreditation Cooperation IAF – International Accreditation Forum world level regional level APLAC, IAAC, SADCA, ARAC… national level National accreditation body peer evaluation process ISO/IEC 17040 ISO/IEC 17011 recognition National accreditation body CAB recognition of equivalence

10. Accreditation standards Accreditation bodyISO/IEC 17011 Accreditation bodies Laboratories Certification bodies Inspection bodies ISO/IEC 17025 Testing and Calibration laboratories ISO/IEC 15189 Medical laboratories ISO/IEC 17020 Inspection ISO 17021 for Management Systems ISO 17024 for Persons ISO 17065 (ISO guide 65; EN 45011) for Products PT scheme providers Producers of reference materials ISO/IEC 17043 Validation and verification bodies ISO 14065 (greenhouse gases) ISO Guide 34

11. EA, ILAC, IAF Accreditation body Conformity assessment body (CAB) Supplier (product/service) e.g. Certification bodies: if compliant with requirements gain accreditation from the Accreditation Body: ASSESING COMPETENCE ASSESING CONFORMITY: certificate Costumer Practice of certification against good standards and independent audits by CB and AB chain: supervision by national authorities can be reduced ∞confidence chain ∞

12. National Accreditation Body General principles for accreditation (Article 4 of Regulation (EC) No. 765/2008) there is only one accreditation body per Member State; where MS considers that is not economically justified to have a national accreditation body/or to provide all accreditation services, recourse shall be given to NAB of another MS (inform Commission and other MSs) accreditation bodies shall operate on a not-for profit basis and comply with the principles of impartiality and objectivity. there is no competition between accreditation bodies and conformity assessment bodies; NAB shall not offer or provide activities of conformity assessment bodies, consultancy services or have financial/managerial interest in CABs accreditation is carried out by a public authority;

13. National Accreditation Body Basic activity: provide accreditation of conformity assessment bodies (in compliance with ISO/IEC 17011:2004) and in compliance with the rules of international accreditation organisations (EA, ILAC, IAF) providing an internationally comparable, transparent, independent and impartial accreditation system that satisfies national need and priorities transparent approach to conformity assessment in all sectors supports regulations cooperates with government (advise the authorities on accreditation and other assessment of competence, promote accreditation…) represents national interests in international organisations

14. National Accreditation Body Auditing team: independence of the auditors ILAC Guidelines on Qualifications and Competence of Assessors and Technical Experts (ILAC-G11) Lead assessor, Technical assessor, Technical expert

15. Accreditation process WHY? regulatory requirement in the regulated sector (basis for nomination of official laboratory by the relevant ministry) voluntary decision in other areas: demanded by costumers, used as a quality label Not a short-term process Before the audit: responsible person - implementation of the quality management system, active commitment of all personnel (in particular top management); documentation, at least one internal audit; at least one management review.

16. Accreditation in Regulation 882/2004 Accreditation is required: if the competent authority delegates specific tasks to a particular control body; for official sampling and analysis; for official laboratories that carry out the analysis of samples taken during official controls (ISO/IEC 17025 on General requirements for the competence of testing and calibration laboratories) it does not allow temporary arrangements

17. Accreditation in Regulation 882/2004 proposal Accreditation to ISO 17025 will remain a mandatory condition for the designation of all official control laboratories (5 year transitional period for plant health laboratories). Permanent derogation from mandatory accreditation of official control laboratories will be introduced for laboratories attached to slaughter houses or game handling establishments carrying out testing, under the supervision of the competent authority, for detection of Trichinella in meat and for laboratories carrying out tests of plant reproductive materials other than plant health analysis or diagnosis. Temporary arrangements

18. Pre-application contacts Submitting application Deciding on the start of procedure and signing the contract Documentation review (submitted by CAB) Site visit Assessment report Evaluating results of assessment Decision: acceptable NO/YES Accreditation Certificate (if approved) initiative by CAB; general information on accreditation, criteria, procedures.. Statement from CAB that actively and fully performs the procedures in application CAB reports on implementation of corrective actions Accreditation Process Preapplication phase Assessment phase Accreditation phase

19. Accreditation Process Maintaining compliance and re-accreditation: - continuing process of establishing that CAB is impartial, technically competent, following the required standard, have appropriate resources… - regular surveillance (e.g. annual) of compliance with quality requirements and technical competence within the accredited scope - re-assessment (following three successive surveillances) - within one assessment period (three successive surveillances and one reassessment) each accredited activity is assessed as a whole at least once (also different locations of key activities are taken into account).

20. Accreditation Process - extension of accredited scope (new methods or activities within an existing field, addition of a new technical field, extension to new sites) – the same as for initial application but... - the scopes of accredited activity may have different degrees of flexibility; where NAB recognise the competence of an accredited body to independently modify or complete the accredited activity.

21. Accreditation Process Fixed scope requires an evaluation of the laboratory’s competence by the accreditation body for a new test/matrix/analyte that is added to the scope. Flexible scope allows adding a new test/matrix/analyte based on a competence evaluation carried out by the laboratory. This inclusion is verified by the accreditation body at the next regular visit.

22. What are the benefits of accreditation? For government (ministries, administrative bodies, executive bodies) assuring public trust in activities, primarily those that affect health, safety and the environment; policy tool that enables formulating efficient regulation and verification systems, and to avoid economic restrictions. within EU, globally: mutual trust in the competencies of conformity assessment bodies – trusting test reports or certificates "passport to international trade„ Non-acceptance of test reports and certificates is one of the major obstacles to trade. key role in the appointment and notification process (delegating tasks: minimizing multiplication of systems, outsourcing…)

23. What are the benefits of accreditation? For society (industry, end users) mechanism for assuring public trust/confidence in the market place and public services: additional guarantee that the products on the market are of high quality and that they meet the general health and safety requirements. competitiveness of the economy (faster and cheaper product placing on international market) the mutual recognition prevent the need for multiple accreditations (adding costs without added value) an important tool in decision making and risk management. society governmentdirect users

24. What are the benefits of accreditation? For direct users condition for obtaining authorisation/nomination to work in the regulated sector competitive advantage, having access to more contracts for testing increase confidence in the results obtained by the laboratory and other results obtained within the scope of accredited activities improve traceability of analysis and lower the probability of incorrect results and other inadequate work enhance proactive actions and in general, with effective management system, help organisation to benefit also in other areas of work society governmentdirect users

25. The goal of an approach of standards-accreditation-certification: continuous improvement in food safety management systems to ensure confidence in the delivery of high-quality and safe food to consumers. Thank you !