Technical requirements

 Sampling

 Analysis

 Reporting of the results

 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)
 The Laboratory Process

Report
Laboratory

Sample
 Intermezzo
 Participantdiscussion on critical
aspects after receipt of the sample,
prior to analysis

Sample
The Laboratory Process: Sampling
Registration
Labelling
Receipt
Disposal
Identification
Temperature control
Storage
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

 Participantdiscussion
the analytical process

Laboratory

Sample
 Analyzing the laboratory
Equipment
Reference standards
Method validation
SOP
Quality Control
Calibration
Uncertainty of measurement
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)

 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
Test and calibration methods,
method validation – 3 (ISO17025:2005, 5.4)

 Validationis 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