Technical requirements

1. Technical requirements • Sampling • Analysis • Reporting of the results

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. Laboratory Report Sample The Laboratory Process

4. Sample Intermezzo • Participant discussion on critical aspects after receipt of the sample, prior to analysis

5. The Laboratory Process: Sampling Registration Labelling Receipt Disposal Identification Temperature control Storage Protection

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. Laboratory Sample Laboratory Process • Participant discussion the analytical process

9. Analyzing the laboratory Equipment Reference standards Method validation SOP Quality Control Calibration Uncertainty of measurement Traceability

10. Equipment - 1(ISO 17025:2005, 5.5) • Identification • Maintenance plan • Calibration according to plan and use • Records are maintained from checks, calibration, maintenance, defects

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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)

20. 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

21. Uncertainty of measurement Random effects: • Short term fluctuations, temperature, pressure, humidity • Variability of measurer Systematic effects: • Offset measuring instrument • Drift between calibrations • Personal bias reading analogue scale • Uncertainty value reference standard

22. Laboratory Report Sample Intermezzo • Participant discussion • Closing the books, critical points for reporting data

23. The Laboratory Process Certificate

24. 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

25. 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

26. 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