1. Lorens P. Sibbesen © 2009 Eurolab TCQA - working for reliable test results Presentation at TAIEX Meeting December 10, 2009 by/ Lorens P. Sibbesen, LAB Quality, Denmark (member of TCQA)

2. Technical Committee on Quality Assurance TCQA – a working group under EUROLAB Technical Committee for Quality Assurance in testing and calibration A horizontal committee composed of one or two experts from the EUROLAB Active and Associated Members At present 17 members from 13 member countries Meeting regularly twice a year + at misc. events Delegating tasks to members to solve between meetings Voluntary work!!

3. Overall aims of TCQA Deal with economic and technical issues regarding Quality Assurance in conformity assessment activities; Support laboratories in developing and maintaining a reasonable quality assurance operation; Collect, analyse and develop knowledge in this field; Share experience gained by laboratories in operating QA systems and make these systems more effective; Identify training and educational needs

4. Overall aims of TCQA (contd.) Plan workshops as well as to produce technical reports and educational material; Request the harmonization of accreditation procedures, the implementation of ISO/CEI 17025 and a broad and suitable application of flexible scope Lead any activities related to the EUROLAB representation in ISO CASCO WGs

5. TCQA coordinating with others TC QA EAAB EUROLAB GABoA EEE-PT EA LC PLG ILAC GA ILAC LC JTC PTC JWG Eurachem ISO CASCO Other relations: CEN, Euramet, CITAC…

6. … and some acronyms (FYI) ! JTCPTC: Joint Technical Committee on Product Testing and Certification (CEOC) CEOC: Confédération Européenne des Organismes de Contrôle (Eng.: European Confederation of Inspection Organisations) ILAC: International Laboratory Accreditation Cooperation (ILAC LC: … Laboratory Committee ) JWG: Joint Working Group EEE-PT: Eurolab, Eurachem, Euramet cooperation on Proficiency Testing PLG: Permanent Liason Group between Eurolab, Eurachem, Euramet, EA & CEOC EA: European co-operation for Accreditation (EAAB: EA Advisory Board / EALC: EA Laboratory Committee) ISO CASCO: International Standard Organisation Conformity ASsessment COmmittee Euramet: European Association of National Metrology Institutes Eurachem: … a focus for analytical chemistry and quality related issues in Europe CITAC: Cooperation on International Traceability in Analytical Chemistry

7. Focus Point: Reliable testresults! Conformity assessment (CA) i many cases based on test results - which again is based on traceable calibrations The right decision about conformity must be based on trust in the reliability of these test results (and the calibrations behind them)

8. QUALITY ASSURANCE in CA ! Quality Assurance of test results  Confidence-building documentation for the results being reliable! …... and (possibly) a formal 3rd party approval of the laboratory being in control – e.g. Accreditation!

9. Tools for establishing reliability The laboratories implement a number of tools for establishing reliability of test results - e.g.:  Securing technical competence of staff  Validating methods  Documenting traceability  Using Reference Materials  Participating in Proficiency Testings  Estimating Measurement Uncertainty  … a.o. - and documenting all this - i.e. establishing a Quality System

10. TCQA in support for these QA efforts! The group within Eurolab specificly and actively dealing with these important issues on a practical level! Issues picked up and dealt with by a group of experts from member states Discussing subjects of common interest towards a consensus – eventually to be published as an Eurolab Policy on the issue Identifying important issues for preparation of guide- lines (or Cook Books) Making survey on common practices in different countries

11. TCQA playing a role for reliability On the formal level (F)  Follow-up on the European Accreditation system and it’s implementation (e.g. Flexible Scope, Cross Frontier Policy, Price policies etc.)  Influencing new standards through ISO CASCO On the practical level (P)  Elaborating guidelines on interpretation of accreditation requirements  Giving “at the lab-desk” common praxis guidance (e.g. Cook Books)  Working on transparency and harmonization of practices within the European member states For the benefit of all members in Europe!

12. TCQA – and accreditation (F) Commenting on EA practices etc.  Joining EAAB and EALC  Discussing new approaches – and giving feed back (both ways) Elaborating guidelines on practical implementation of accreditation requirements  In cooperation with other organisations (ILAC, Eurachem a.o.) Following up upon the use – and implications – of an accreditation mark on test reports Dealing with the principles of Flexible Scope  Survey on practices within Europe  Workshop in Prague, Nov. 2009

13. TCQA – and standardization (F) Eurolab granted A-liaison status with ISO CASCO  Giving right to send delegates to WGs  TCQA has nominated a member to WG on revision of ISO 17025  Following the development of new standard ISO 17043 on PT schemes Following development of new CEN standards

14. TCQA – guiding the laboratories (P) Preparation of a number of Guidelines, Technical Reports and general position papers - E.g.:  Measurement uncertainty revisited: Alternative approaches to uncertainty evaluation (2007)  Guidance for the management of computers and software in laboratories with reference to ISO/IEC 17025 (2006)  Measurement uncertainty arising from sampling (2007)  Produced in cooperation with Eurachem a.o. Reading list on Measurement Uncertainty  Following the development

15. TCQA – dissemination of good practices (P) Exchange of good practices  The Cook Books [as mentioned in previoius lecture!]  Facilitating contacts between national member organisations (Networking!) Arranging seminars and workshops E.g.  Sampling Uncertainty and Uncertainty for Compliance Assessment (Berlin, April 2008) - in cooperation with Eurachem and CITAC

16. TCQA – working for hamonization Surveys on practices in different member states  Flexible Scope for Accreditation (summer 2009)  Price Policies for Accreditation (planned)  a.o. Cooperation on the international scene  E.g. commenting on ILAC documents Using position for influencing future, common practices  E.g. discussing Cross Frontier Policy Close contact to national member organisations

17. Conclusion: Eurolab TCQA a key player in CA! Reliable testresults! One way of supporting the CA processes in Europe! Follow-up upon Accr. system (EA) Influencing relevant standards Preparation of guidelines ”Cook Books” Seminars and Workshops Networking

18. Thank you for your attention!

19. My background… Lorens P. Sibbesen (lps@labqa.dk )lps@labqa.dk Chemical Engineer Worked with analytical laboratories and QA in laboratories since 1987 Self-employed with LAB Quality since 2000 (www.labqa.dk )www.labqa.dk Secretary of Eurolab Denmark Member of TCQA since 2007 Member of Eurachem GA, AOAC a.o. Working on projects for improvement of Quality Infrastructure in e.g. Turkey, Jordan, Latvia a.o.