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Technical requirements Sampling Analysis Reporting of the results
Quality Selecting analytical procedures suitable for answering the analytical questions (good science) Performing the se...
The Laboratory Process                       Report          LaboratorySample
Intermezzo Participant discussion on critical aspects after receipt of the sample, prior to analysis    Sample
The Laboratory Process: Sampling                    Registration                    Labelling                    Receipt  ...
Sampling             ( ISO 17025:2005, 5.7, 5.8 )Sampling plan and procedures:   Statistically based appropriate   Devia...
Laboratory Process Participant discussion the analytical process               LaboratorySample
Analyzing the laboratoryEquipmentReference standardsMethod validationSOPQuality ControlCalibrationUncertainty of measureme...
Equipment - 1               (ISO 17025:2005, 5.5) Identification Maintenance plan Calibration according to plan and use...
Equipment - 2              (ISO 17025:2005, 5.5) Adequate equipment is required for the  correct performance of tests, me...
Equipment - 3               (ISO 17025:2005, 5.5) Equipment out of laboratory or calibrated  is tested first for correct ...
Equipment - 4               (ISO 17025:2005, 5.5) Handling of defect equipment If calibration results in correction fact...
Test and calibration methods and method validation -1(ISO 17025:2005, 5.4) Use of appropriate methods within its  scope (...
Test and calibration methods,method validation - 2 (ISO17025:2005, 5.4) Laboratory–developed methods are  planned activit...
Test and calibration methods,method validation – 3 (ISO17025:2005, 5.4) Validation is the confirmation by examination and...
Test and calibration methods, method validation - 4 (ISO17025:2005, 5.4) Validation items: Uncertainty of results, detec...
Test and calibration methods,method validation – 5 (ISO17025:2005, 5.4) A procedure has to be applied to estimate  the un...
Assuring the quality of             test/calibration results                  (ISO 17025:2005, 5.10)Resulting data are rec...
Uncertainty of measurementRandom effects: Short term fluctuations, temperature, pressure,  humidity Variability of measu...
IntermezzoParticipant discussionClosing the books, critical points for reporting data                            Report ...
The Laboratory Process           Certificate
Reporting results -1              (ISO 17025:2005, 5.10) The laboratory has to report all requested  information to the c...
Reporting results - 2             (ISO 17025:2005, 5.10) Where necessary for interpretation of  results deviations are gi...
Reporting results - 3              (ISO 17025:2005, 5.10) Electronical transmission of results is  allowed Opinions and ...
Sampling analysis-reporting
Sampling analysis-reporting
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Sampling analysis-reporting

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Sampling analysis-reporting

  1. 1. Technical requirements Sampling Analysis Reporting of the results
  2. 2. Quality Selecting analytical procedures suitable for answering the analytical questions (good science) Performing the selected tests in a traceable manner, according to clear and transparent procedures under proper conditions (good QA system)
  3. 3. The Laboratory Process Report LaboratorySample
  4. 4. Intermezzo Participant discussion on critical aspects after receipt of the sample, prior to analysis Sample
  5. 5. The Laboratory Process: Sampling Registration Labelling Receipt Disposal Identification Temperature control Storage Protection
  6. 6. Sampling ( ISO 17025:2005, 5.7, 5.8 )Sampling plan and procedures: Statistically based appropriate Deviations required by customer are recorded and reported Recording data as sampling procedure, identification of sampler, sampling location, statistics as appropriate Abnormalities of samples are recorded Secure storage -> further investigations or return to service
  7. 7. Laboratory Process Participant discussion the analytical process LaboratorySample
  8. 8. Analyzing the laboratoryEquipmentReference standardsMethod validationSOPQuality ControlCalibrationUncertainty of measurementTraceability
  9. 9. Equipment - 1 (ISO 17025:2005, 5.5) Identification Maintenance plan Calibration according to plan and use Records are maintained from checks, calibration, maintenance, defects
  10. 10. Equipment - 2 (ISO 17025:2005, 5.5) Adequate equipment is required for the correct performance of tests, meets specifications (IQ, PQ, OQ) Equipment is operated by authorized personnel Up-to-date instructions are present for use and maintenance
  11. 11. Equipment - 3 (ISO 17025:2005, 5.5) Equipment out of laboratory or calibrated is tested first for correct functioning before returning to service Calibration state is controlled and if verification checks of calibration are needed they are carried out
  12. 12. Equipment - 4 (ISO 17025:2005, 5.5) Handling of defect equipment If calibration results in correction factors procedures are available to ensure that copies (computer software) are correctly updated Safeguarding from adjustments (hardware and software) which invalidates results
  13. 13. Test and calibration methods and method validation -1(ISO 17025:2005, 5.4) Use of appropriate methods within its scope (handling samples and estimation measerements uncertainty) Preferably use of methods published in international, regional or national standards Appropriate method is chosen/advised by laboratory
  14. 14. Test and calibration methods,method validation - 2 (ISO17025:2005, 5.4) Laboratory–developed methods are planned activities and assigned to qualified personel with adequate resources Plans are updated and communicated as development proceeds Validation of non-standard methods is required
  15. 15. Test and calibration methods,method validation – 3 (ISO17025:2005, 5.4) Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled Validation is required for non-standard methods, standard method used outside their scope or modified methods
  16. 16. Test and calibration methods, method validation - 4 (ISO17025:2005, 5.4) Validation items: Uncertainty of results, detection limit, selectivity, linearity, limit of repeatability, reproducibility, robustness against external influences, interference from the matrix of the sample object Validation shall be relevant for the customer needs
  17. 17. Test and calibration methods,method validation – 5 (ISO17025:2005, 5.4) A procedure has to be applied to estimate the uncertainty of measurements for calibrations: reference is Guide to the Expression of Uncertainty of Measurement Use knowledge and experimental data (validation,quality controls, profiency tests)
  18. 18. Assuring the quality of test/calibration results (ISO 17025:2005, 5.10)Resulting data are recorded and trend analysis (if practicable by statistics) carried out: regular use of reference materials/and or internal quality control Interlaboratory comparison (profiency tests) Replicate tests using the same or different methods Retesting of retained items Correlation of results for different characteristics of an item Planned action is undertaken when data are OOS, correction of problem and prevention being reported
  19. 19. Uncertainty of measurementRandom effects: Short term fluctuations, temperature, pressure, humidity Variability of measurerSystematic effects: Offset measuring instrument Drift between calibrations Personal bias reading analogue scale Uncertainty value reference standard
  20. 20. IntermezzoParticipant discussionClosing the books, critical points for reporting data Report Laboratory Sample
  21. 21. The Laboratory Process Certificate
  22. 22. Reporting results -1 (ISO 17025:2005, 5.10) The laboratory has to report all requested information to the customer Results are reported with complete information about laboratory, customer, sample data, used method, authorizing personnel A simplified report is allowed for internal customers or if agreed with the customer
  23. 23. Reporting results - 2 (ISO 17025:2005, 5.10) Where necessary for interpretation of results deviations are given Where relevant compliance or non- compliance statement is given If applicable estimated uncertainty of measurement Identification of results from subcontractors
  24. 24. Reporting results - 3 (ISO 17025:2005, 5.10) Electronical transmission of results is allowed Opinions and interpretations are out of accreditation, clearly marked and the basis has to be documented Admendments are marked as supplement to original test report, or if a new report is necessary shall refer to the original report

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