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Pieter de Beer debeer@eps.tno.nl TNO EPS The Netherlands

INCOLAB – Final conference. Bled, Slovenia September 14, 2006 - Accreditation - Support or an obstacle for a testing laboratory. Pieter de Beer debeer@eps.tno.nl TNO EPS The Netherlands. Content of presentation. Testing laboratories History Current situation Financial issues

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Pieter de Beer debeer@eps.tno.nl TNO EPS The Netherlands

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  1. INCOLAB – Final conference Bled, SloveniaSeptember 14, 2006- Accreditation - Support or an obstacle for a testing laboratory Pieter de Beer debeer@eps.tno.nl TNO EPS The Netherlands

  2. Content of presentation • Testing laboratories • History • Current situation • Financial issues • Accreditation • Laboratory accreditation IEC 17025 • Quality system and Audits • Accredited Activities • Observations • Costs • Goals • Does it meet the objectives?? INCOLAB Bled, September 14, 2006

  3. Testing LaboratoriesOverview • Governmental task • Making & implementing the laws • Testing without accreditation • Market surveillance • Privatization • Changes in legislations (EU!) • Changes in responsibilities • Testing as accredited laboratory • Competition • EU & world wide • Administrations!!?? INCOLAB Bled, September 14, 2006

  4. Testing LaboratoriesHistory • A priory testing • Compliance verified (guaranteed?) • Mandatory testing • Protected position (no commercial pressure) • No market interface • Monopoly • Appointed • National requirements • Accreditation? • Liability • Government INCOLAB Bled, September 14, 2006

  5. Testing LaboratoriesCurrent situation • After market access testing • A posterior testing (Directive dependent) • Presumption of compliance declared • No mandatory testing • EU requirements (harmonization) • Appointed • Not appointed, free competition • Accreditation needed? • Liabilities • Manufacturer • Market surveillance INCOLAB Bled, September 14, 2006

  6. Old situation Part of market access procedure per country! Financed by applicant Testing costs Administration costs (access) No limit in budgets Compliance verified Market surveillance Budget? New situation Part of market access procedure just once for EU Financed by applicant Testing fee No administration costs Commercial budget Compliance declared Market surveillance Budget? Testing LaboratoriesFinancial issues INCOLAB Bled, September 14, 2006

  7. Accreditation • Old situation: • National appointment requirements • New situation: • Directive requirements • Laboratories: • Accredited • Not accredited • Task Laboratory • Compliance testing • Essential requirements (Directives) • Testing & “certification” in one entity • Accreditation • IEC 17025 INCOLAB Bled, September 14, 2006

  8. Accreditation (cont) • Task Laboratory: • Only testing? • Consultancy? • Market access? • IEC 17025 • Primary for testing • Quality system • Management requirements (clause 4) • Technical requirements (clause 5) • Conflict of interest (clause 4.1.4) • It is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgment. The third-party testing laboratory should not engage in any activities that may endanger the trust in its independence of judgment and integrity in relation to its testing activities. INCOLAB Bled, September 14, 2006

  9. Quality system and audits • Effort • 64 phenomena (TNO EPS) • Quality manual • 20 pages (1989), >60 pages (2006) • Procedures & Instructions • Preventive & corrective actions • Maintenance of standard (new versions) • Internal audits & management reviews • Many hours per year • Quality manager • Department of 10 people……. INCOLAB Bled, September 14, 2006

  10. Accredited activities • Scope of accreditation • Phenomena ?? • Standards?? • Yearly BOA inspection: • All 17025 aspects (Q-management) • Accredited phenomena • All phenomena in 4 year (..) • Experts • Result of the BOA audits • Ever growing quality system • Always actions needed • Detailed • Measurement uncertainties EMC INCOLAB Bled, September 14, 2006

  11. Observations • Costs • of inspections of the BOA • of labor related to the Q-system • of verification and calibration • Goals • Assist customers to achieve a presumption of compliance.... • To offer good quality • Differences in interpretations in EU • In scope of accreditation • Results of BOA inspections • Are all details really relevant? INCOLAB Bled, September 14, 2006

  12. Observations (cont) Does accreditation meet the objectives ? INCOLAB Bled, September 14, 2006

  13. End of presentation • Questions? INCOLAB Bled, September 14, 2006

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