Benefits of International Accreditation Cooperation for Medical laboratories Christina Waddington Accreditation Manager, FINAS
Why accreditation? Accreditation is a third party evaluation and demonstration of competence The principles and rules of accreditation are stated in international standards and procedures are harmonised in the international cooperation between accreditation bodies Stakeholders have an important role in the development of accreditation services, to ensure that the service is fit for purpose and the assessments give added value to the clients of accreditation Stakeholders are the direct clients, indirect clients, EU commission, national authorities, regulators, suppliers, client organisations, consumers
Accreditation services for medical laboratories accreditation of laboratories according to ISO 15189 accreditation of laboratories according to ISO/IEC 17025 accreditation of reference medical laboratories according to ISO 15195 in combination with ISO/IEC 17025 accreditation of PT providers according to ISO Guide 43 ( in the future ISO/IEC 17043) In addition accredited certification schemes also serve the medical sector, such as ISO 9001, ISO 14001 and ISO 13485. A new scheme under development in the EU is an accreditation/certification scheme for breast cancer screening based on EU Brest Screening and Diagnosis Guidelines, where ECN (European Cancer Network) and EA cooperate.
New role of accreditation within EU New legislative package EC 765/2008) has been approved June 2008 and published August 2008. Will come into force 1.1.2010. Regulation for the requirements for accreditation and market surveillance Sets a number of requirements for the EU Member States, including the operation of one singe accreditation body in the Member States, non-competition of accreditation bodies Provides recognition of EA European Cooperation of Accreditation Strengthens the use of accreditation also in the mandatory area
Structure of international cooperation of accreditation EA European Cooperation of Accreditation on the European (regional) level Membership: 35 full members, of which 33 are signatories of the MLA and 17 associate members Strong stakeholder cooperation in EAAB and at committee levels Committee structure: EA Executive Committee, EA Harmonisation Committee, EA Laboratory Committee, EA Certification Committee, EA Inspection Committee, EA Communication and Publication Committee MLA Council for the multilateral agreement Medical laboratory issues: EA Laboratory Committee (FINAS repr. Christina Waddington, chair) Working Group Health Care (FINAS repr. Tuija Sinervo) For more information about EA: www.european-accreditation.org
Structure of international cooperation of accreditation ILAC International Laboratory Accreditation Cooperation (international level) Members: regional members: EA, APLAC, IAAC, SADCA, non-affiliated members Committees: ILAC Executive, ILAC Accreditation Issues Committee, ILAC Arrangement Committee, ILAC Laboratory committee, Proficiency Testing Consultative Group, Joint Development Support Committee, etc Arrangement Management Committee Medical laboratories issues: ILAC Accreditation Issues Committee (FINAS repr Christina Waddington) Working group for medical laboratories (FINAS repr Tuija Sinervo) For more information about ILAC: www.ilac.org
The EA Multilateral Agreement (EA MLA) Accredited once, accepted everywhere the equivalence of the operation of the accreditation systems administered by EA Members; that the certificates and reports issued by organisations accredited by EA Members are equally reliable. The MLA is an agreement signed between the EA accreditation body members to recognise the equivalence, reliability and therefore acceptance of accredited calibration certificates and test reports across Europe. The MLA eliminates the need for suppliers of services or products to be accredited in each country where they operate, and therefore provides a means for goods and services to cross boundaries in Europe and throughout the world. For medical laboratories this means that accredited test results and test results produced in an accredited laboratory in one country is considered reliable all over the world.
The EA Multilateral Agreement (EA MLA) The strength of the EA MLA is maintained through a robust peer evaluation process. The purpose of these rigorous on-site evaluations is to verify the Accreditation Body signatories' continuing conformity with the internationally accepted criteria. ABs are evaluated against the international standard ISO/IEC 17011, other related criteria such as application documents from EA, ILAC or IAF and applicable criteria on behalf of European or National Regulators and industrial schemes. The MLA process is overseen by the European Commission, the EA Advisory Board and the national authorities.
Signatories of the EA MLA (end of 2008) testing and calibration BMWA (Austria) BELAC (Belgium) CAI (Czech Republic) DANAK (Denmark) EAK (Estonia) FINAS (Finland) COFRAC (France) DACH (Germany), DAP (Germany), TGA (Germany), DK ESYD (Greece) INAB (Ireland) SINAL (Italy), SIT (Italy) LATAK (Latvia), LA (Lithuania), NAB-MALTA (Malta), RvA (The Netherlands) NA (Norway) PCA (Poland) RENAR (Romania) SNAS (Slovakia) ENAC (Spain) SWEDAC (Sweden) SAS (Switzerland) TUNAC (Tunisia) TURKAK (Turkey) UKAS (United Kingdom).
ILAC Mutual Recognition Arrangement ILAC MRA Agreements in the regional accreditation cooperation are the basis for the ILAC MRA Unaffiliated bodies are evaluated directly Regional accreditation bodies MLA activity is evaluated by ILAC (and IAF) General rules for the evaluation of accreditation body and regional cooperation are agreed on at the international level. EA has some additional requirements due to the special agreement with the EU commission Right to use ILAC mark
The international accreditation marks TXXX (EN ISO 15189)
Benefits of international accreditation cooperation Stakeholder influence on all levels (rules, procedures, strategies) The multilateral agreement arrangement gives trust to assessment and decision making of the national accreditation bodies Mutual recognition internationally The status of accreditation is strengthened within Europe as defined in the new EU legislation Use of the national and international accreditation marks clarifies that the accredited test results are given within the MLA For accredited laboratories and users of their services we achieve confidence with competence