Technical requirements

Sampling

Analysis

Reporting of the results
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)
Quality
The Laboratory Process
Laboratory
Report
Sample
Intermezzo
Participant discussion on critical
aspects after receipt of the sample,
prior to analysis
Sample
The Laboratory Process: Sampling
Registration
Labelling
Identification
Storage
Temperature control
Receipt
Disposal
Protection
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


Laboratory Process
Laboratory

Participant discussion
the analytical process
Sample

Analyzing the laboratory
Equipment
Reference standards
Quality Control
Uncertainty of measurement
Calibration
Method validation
SOP
Traceability
Equipment - 1
(ISO 17025:2005, 5.5)
Identification
Maintenance plan
Calibration according to plan and use
Records are maintained from checks,
calibration, maintenance, defects

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

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


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

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
Test and calibration methods,
method validation - 2 (ISO17025:2005, 5.4)
Laboratorydeveloped 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
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

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
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)

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
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

Intermezzo
Participant discussion
Closing the books, critical points
for reporting data
Report
Laboratory
Sample
The Laboratory Process
Certificate
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

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

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