Technical requirementsTechnical requirements

SamplingSampling

AnalysisAnalysis

Reporting of the resultsReporting of the results

Selecting analytical procedures suitable for Selecting analytical procedures suitable for answering the analytical questions (good answering the analytical questions (good science)science)

Performing the selected tests in a Performing the selected tests in a traceable manner, according to clear and traceable manner, according to clear and transparent procedures under proper transparent procedures under proper conditions (good QA system)conditions (good QA system)

QualityQuality

The Laboratory ProcessThe Laboratory Process

LaboratoryLaboratory

ReportReport

SampleSample

IntermezzoIntermezzoParticipant discussion on critical Participant discussion on critical

aspects after receipt of the sample, aspects after receipt of the sample, prior to analysisprior to analysis

SampleSample

The Laboratory Process: SamplingThe Laboratory Process: Sampling

RegistrationRegistrationLabellingLabelling

IdentificationIdentification

StorageStorageTemperature controlTemperature control

ReceiptReceiptDisposalDisposal

ProtectionProtection

SamplingSampling( ISO 17025:2005, 5.7, 5.8 )( ISO 17025:2005, 5.7, 5.8 )

Sampling plan and procedures:Sampling plan and procedures:

Statistically based appropriate Statistically based appropriate Deviations required by customer are recorded Deviations required by customer are recorded

and reportedand reported Recording data as sampling procedure, Recording data as sampling procedure,

identification of sampler, sampling location, identification of sampler, sampling location, statistics as appropriatestatistics as appropriate

Abnormalities of samples are recordedAbnormalities of samples are recorded Secure storage -> further investigations or Secure storage -> further investigations or

return to servicereturn to service

Laboratory ProcessLaboratory Process

LaboratoryLaboratory

Participant discussion Participant discussion the analytical processthe analytical process

SampleSample

Analyzing the laboratoryAnalyzing the laboratory

EquipmentReference standards

Quality Control

Uncertainty of measurementCalibration

Method validationSOP

Traceability

Equipment - 1Equipment - 1(ISO 17025:2005, 5.5)(ISO 17025:2005, 5.5)

Identification Identification Maintenance planMaintenance plan Calibration according to plan and useCalibration according to plan and use Records are maintained from checks, Records are maintained from checks,

calibration, maintenance, defectscalibration, maintenance, defects

Equipment - 2Equipment - 2(ISO 17025:2005, 5.5)(ISO 17025:2005, 5.5)

Adequate equipment is required for the Adequate equipment is required for the correct performance of tests, meets correct performance of tests, meets specifications (IQ, PQ, OQ) specifications (IQ, PQ, OQ)

Equipment is operated by authorized Equipment is operated by authorized personnelpersonnel

Up-to-date instructions are present for use Up-to-date instructions are present for use and maintenanceand maintenance

Equipment - 3Equipment - 3(ISO 17025:2005, 5.5)(ISO 17025:2005, 5.5)

Equipment out of laboratory or calibrated Equipment out of laboratory or calibrated is tested first for correct functioning before is tested first for correct functioning before returning to servicereturning to service

Calibration state is controlled and if Calibration state is controlled and if verification checks of calibration are verification checks of calibration are needed they are carried out needed they are carried out

Equipment - 4Equipment - 4(ISO 17025:2005, 5.5)(ISO 17025:2005, 5.5)

Handling of defect equipmentHandling of defect equipment If calibration results in correction factors If calibration results in correction factors

procedures are available to ensure that procedures are available to ensure that copies (computer software) are correctly copies (computer software) are correctly updatedupdated

Safeguarding from adjustments (hardware Safeguarding from adjustments (hardware and software) which invalidates resultsand software) which invalidates results

Test and calibration methods and Test and calibration methods and method validation -1method validation -1(ISO 17025:2005, 5.4)(ISO 17025:2005, 5.4)

Use of appropriate methods within its Use of appropriate methods within its scope (handling samples and estimation scope (handling samples and estimation measerements uncertainty)measerements uncertainty)

Preferably use of methods published in Preferably use of methods published in international, regional or national international, regional or national standardsstandards

Appropriate method is chosen/advised by Appropriate method is chosen/advised by laboratory laboratory

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

Laboratory–developed methods are Laboratory–developed methods are planned activities and assigned to planned activities and assigned to qualified personel with adequate qualified personel with adequate resourcesresources

Plans are updated and communicated as Plans are updated and communicated as development proceedsdevelopment proceeds

Validation of non-standard methods is Validation of non-standard methods is requiredrequired

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

Validation is the confirmation by Validation is the confirmation by examination and the provision of objective examination and the provision of objective evidence that the particular requirements evidence that the particular requirements for a specific intended use are fulfilledfor a specific intended use are fulfilled

Validation is required for non-standard Validation is required for non-standard methods, standard method used outside methods, standard method used outside their scope or modified methodstheir scope or modified methods

Test and calibration methods, Test and calibration methods, method validation - 4 method validation - 4 (ISO17025:2005, 5.4)(ISO17025:2005, 5.4)

Validation items: Validation items: Uncertainty of results, detection limit, Uncertainty of results, detection limit,

selectivity, linearity, limit of repeatability, selectivity, linearity, limit of repeatability, reproducibility, robustness against external reproducibility, robustness against external influences, interference from the matrix of influences, interference from the matrix of the sample object the sample object

Validation shall be relevant for the Validation shall be relevant for the customer needscustomer needs

Test and calibration methods, Test and calibration methods, method validation – 5 method validation – 5 (ISO17025:2005, 5.4)(ISO17025:2005, 5.4)

A procedure has to be applied to estimate A procedure has to be applied to estimate the uncertainty of measurements for the uncertainty of measurements for calibrations: reference is Guide to the calibrations: reference is Guide to the Expression of Uncertainty of MeasurementExpression of Uncertainty of Measurement

Use knowledge and experimental data Use knowledge and experimental data (validation,quality controls, profiency tests) (validation,quality controls, profiency tests)

Assuring the quality of Assuring the quality of test/calibration resultstest/calibration results

(ISO 17025:2005, 5.10)(ISO 17025:2005, 5.10)Resulting data are recorded and trend analysis (if Resulting data are recorded and trend analysis (if

practicable by statistics) carried out:practicable by statistics) carried out:

regular use of reference materials/and or internal quality regular use of reference materials/and or internal quality controlcontrol

Interlaboratory comparison (profiency tests)Interlaboratory comparison (profiency tests) Replicate tests using the same or different methodsReplicate tests using the same or different methods Retesting of retained itemsRetesting of retained items Correlation of results for different characteristics of an Correlation of results for different characteristics of an

itemitem Planned action is undertaken when data are OOS, Planned action is undertaken when data are OOS,

correction of problem and prevention being reported correction of problem and prevention being reported

Uncertainty of measurementUncertainty of measurement

Random effects:Random effects: Short term fluctuations, temperature, pressure, Short term fluctuations, temperature, pressure,

humidityhumidity Variability of measurerVariability of measurer

Systematic effects:Systematic effects: Offset measuring instrumentOffset measuring instrument Drift between calibrationsDrift between calibrations Personal bias reading analogue scalePersonal bias reading analogue scale Uncertainty value reference standardUncertainty value reference standard

IntermezzoIntermezzoParticipant discussionParticipant discussionClosing the books, critical points Closing the books, critical points

for reporting datafor reporting data

ReportReportLaboratoryLaboratory

SampleSample

The Laboratory ProcessThe Laboratory Process

Certificate

Reporting results -1Reporting results -1(ISO 17025:2005, 5.10)(ISO 17025:2005, 5.10)

The laboratory has to report all requested The laboratory has to report all requested information to the customer information to the customer

Results are reported with complete Results are reported with complete information about laboratory, customer, information about laboratory, customer, sample data, used method, authorizing sample data, used method, authorizing personnel personnel

A simplified report is allowed for internal A simplified report is allowed for internal customers or if agreed with the customercustomers or if agreed with the customer

Reporting results - 2Reporting results - 2(ISO 17025:2005, 5.10)(ISO 17025:2005, 5.10)

Where necessary for interpretation of Where necessary for interpretation of results deviations are givenresults deviations are given

Where relevant compliance or non-Where relevant compliance or non-compliance statement is given compliance statement is given

If applicable estimated uncertainty of If applicable estimated uncertainty of measurementmeasurement

Identification of results from Identification of results from subcontractorssubcontractors

Reporting results - 3Reporting results - 3(ISO 17025:2005, 5.10)(ISO 17025:2005, 5.10)

Electronical transmission of results is Electronical transmission of results is allowedallowed

Opinions and interpretations are out of Opinions and interpretations are out of accreditation, clearly marked and the accreditation, clearly marked and the basis has to be documentedbasis has to be documented

Admendments are marked as supplement Admendments are marked as supplement to original test report, or if a new report is to original test report, or if a new report is necessary shall refer to the original reportnecessary shall refer to the original report