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Conformity Assessment in “Chemical Analysis”

Conformity Assessment in “Chemical Analysis”. Ed W.B. de Leer NMi Van Swinden Laboratorium The Netherlands. Contents. Introduction Confusion: Conformity Assessment vs Testing Metrological needs Impact of CA in Chemistry. Conformity Assessment Process. Accredited laboratories.

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Conformity Assessment in “Chemical Analysis”

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  1. Conformity Assessment in“Chemical Analysis” Ed W.B. de Leer NMi Van Swinden Laboratorium The Netherlands NMi - the Art of Measurement

  2. Contents • Introduction • Confusion: Conformity Assessment vs Testing • Metrological needs • Impact of CA in Chemistry NMi - the Art of Measurement

  3. Conformity Assessment Process Accredited laboratories Courtesy: Jos Leferink (RvA) NMi - the Art of Measurement

  4. Definitions (ISO/IEC 17000) • Conformity assessmentDemonstration that specified requirements relating to a product, process, system, person or body are fulfilled • TestingDetermination of one ore more characteristics of an object of conformity assessment, according to a procedure NMi - the Art of Measurement

  5. Testing (other definitions) • TestProcedure for critical evaluation;a means of determining the presence, quality, or truth of something;a physical or chemical change by which a substance may be detected or its properties ascertained NMi - the Art of Measurement

  6. Testing or Conformity Assessment ? Testing CA Calibration CA CRM producers NMi - the Art of Measurement

  7. Confusion ?? • ISO/IEC 17000 • Accreditation Third party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks It would have been better to define “accreditation of conformity assessment bodies” NMi - the Art of Measurement

  8. Accredited chemical laboratories • Dutch situation • 223 RvA accredited testing laboratories • Approximately 40% in field of “chemistry” • 72 RvA accredited calibration laboratories • Approximately 10% in field of “chemistry” • 5 RvA accredited medical laboratories • 142 CCKL accredited clinical laboratories NMi - the Art of Measurement

  9. Chemical Testing Laboratories • Environmental analysis • Water, Soil, Air • Sampling • Food analysis • Chemistry and microbiology • Agriculture • Petrochemical analysis • Industrial testing • Clinical analysis • Drug analysis NMi - the Art of Measurement

  10. Measurement Results and Comparability – Testing to Limits • Measurement results must be comparable when the measurements are conducted by different parties, in different places and at different times NMi - the Art of Measurement

  11. Field Laboratories Courtesy: IRMM NMi - the Art of Measurement

  12. Metrological needs • Traceability – CRMs • NMIs • Accredited CRM producers • Standards for the detemination of measurement uncertainty in specific testing areas • Training • Comparisons • Consensus vs Traceable reference values NMi - the Art of Measurement

  13. Impact of Conformity Assessment of chemical parameters • Environment (examples) • Soil remediation • Air quality regulations in relation to housing • Food analysis • Certification schemes – complex interpretations • Industrial / Petrochemical analysis • Public / private discussion • Drug analysis • Doping • Medical / Clinical analysis • In Vitro Medical Devices NMi - the Art of Measurement

  14. Conclusion • Conformity Assessment (CA) in Chemistry has enormous impact on environment, economy/trade and quality of life • Comparability of measurement results in chemistry still needs improvement • Metrological tools are lacking in many cases • Comparisons become the basis for demonstrating competence in CA NMi - the Art of Measurement

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