The document discusses the key steps in a laboratory process for sampling, analyzing samples, and reporting results. It covers technical requirements for sampling and analysis, selecting suitable analytical procedures, maintaining quality assurance, and describing the flow from receiving samples to issuing a report. Critical aspects like equipment calibration, method validation, quality control, and estimating measurement uncertainty are emphasized.

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. The Laboratory Process
Report
Laboratory
Sample

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

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 Process
 Participant discussion
the analytical process
Laboratory
Sample

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

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