Peter Askolin, M. Sc. Peter Askolin, M. Sc. ( ( Chemistry Chemistry ) ) Lead assessor at Division of Lead assessor at Division of Chemistry Chemistry Swedish Board of Swedish Board of Accreditation and Accreditation and Conformity Assessment Conformity Assessment SWEDAC SWEDAC
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Peter Askolin, M. Sc. ( Chemistry ) Lead assessor at Division of Chemistry
Peter Askolin, M. Sc. ( Chemistry ) Lead assessor at Division of Chemistry. Swedish Board of Accreditation and Conformity Assessment SWEDAC. Issues. Short introduction of SWEDAC Accreditation procedure Accreditation requirements according to EN ISO/IEC 17025 (Flexible scope (or not)) - PowerPoint PPT Presentation
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Peter Askolin, M. Sc. Peter Askolin, M. Sc. ((ChemistryChemistry))
Lead assessor at Division of ChemistryLead assessor at Division of Chemistry
Swedish Board of Accreditation Swedish Board of Accreditation and Conformity Assessmentand Conformity Assessment
SWEDACSWEDAC
Peter Askolin, SWEDACPeter Askolin, SWEDAC 22
Issues Issues
Short introduction of SWEDACShort introduction of SWEDAC Accreditation procedureAccreditation procedure Accreditation requirements according to Accreditation requirements according to
EN ISO/IEC 17025EN ISO/IEC 17025 (Flexible scope (or not))(Flexible scope (or not)) Statistics about medical laboratories Statistics about medical laboratories
accredited by SWEDAC and DANAKaccredited by SWEDAC and DANAK
Peter Askolin, SWEDACPeter Askolin, SWEDAC 33
SWEDACSWEDACBoard of Accreditation and Board of Accreditation and Conformity Assessment Conformity Assessment
Placed under the Foreign DepartmentPlaced under the Foreign Department Handles all Technical Control in SwedenHandles all Technical Control in Sweden Divided in 3 divisions that are handling Divided in 3 divisions that are handling
accreditation of laboratories.accreditation of laboratories. General technologyGeneral technology ChemistryChemistry Medical Technology and ElectrotechnicsMedical Technology and Electrotechnics
EN ISO/IEC 17025EN ISO/IEC 17025First edition 1999-12-15 First edition 1999-12-15
General requirements for the General requirements for the competence of testing and competence of testing and
calibration laboratoriescalibration laboratories
Peter Askolin, SWEDACPeter Askolin, SWEDAC 55
EN ISO/IEC 17025EN ISO/IEC 17025
Replaces EN 45001Replaces EN 45001 International ISO standardInternational ISO standard A general standard not only for A general standard not only for
accreditation useaccreditation use Divided into 2 partsDivided into 2 parts
Incorporates ISO 9001 and 2 requirementsIncorporates ISO 9001 and 2 requirements Big efforts is made to guarantee the Big efforts is made to guarantee the
independency of the laboratory.independency of the laboratory. Potential conflicts in interests shall be identified Potential conflicts in interests shall be identified
(e.g. the laboratory is placed directly under (e.g. the laboratory is placed directly under production) production)
Personnel and management shall be free from Personnel and management shall be free from financial, commercial and other pressures financial, commercial and other pressures (external) (external)
Technical management Technical management Quality systemQuality system Contracting reviewsContracting reviews Subcontracting tests to other laboratoriesSubcontracting tests to other laboratories Internal audit and Management reviewInternal audit and Management review Corrective actions and preventive actionsCorrective actions and preventive actions Control of recordsControl of records
Peter Askolin, SWEDACPeter Askolin, SWEDAC 88
Technical managementTechnical management
Technical leader shall be pointed out and Technical leader shall be pointed out and deputie(s) for him.deputie(s) for him. Has the overall responsibility of laboratory Has the overall responsibility of laboratory
operations.operations. Leads the laboratory work so that the required Leads the laboratory work so that the required
quality is reached.quality is reached. Technical competenceTechnical competence
Peter Askolin, SWEDACPeter Askolin, SWEDAC 99
Contract reviewsContract reviews
Confirmation that both the laboratory and Confirmation that both the laboratory and its customer have understood the its customer have understood the commissioned work in the same mannercommissioned work in the same manner
Confirmation that the laboratory has Confirmation that the laboratory has necessary competence and resources for necessary competence and resources for the commissioned workthe commissioned work
Shall include work that is subcontracted to Shall include work that is subcontracted to other laboratories.other laboratories.
Peter Askolin, SWEDACPeter Askolin, SWEDAC 1010
SubcontractingSubcontracting
Accreditation can only be granted for work Accreditation can only be granted for work that the laboratory usually performs itself.that the laboratory usually performs itself.
Shall be reported and approved by the Shall be reported and approved by the customercustomer
Shall clearly be marked out.Shall clearly be marked out. The laboratory shall make sure that the The laboratory shall make sure that the
subcontractor works according to the std.subcontractor works according to the std. The laboratory have overall responsibilityThe laboratory have overall responsibility
Peter Askolin, SWEDACPeter Askolin, SWEDAC 1111
Internal audits Internal audits
Shall be performed regularlyShall be performed regularly Shall include all activities and elementsShall include all activities and elements Shall be carried out by trained and Shall be carried out by trained and
qualified personnelqualified personnel Independent from the activity being Independent from the activity being
audited audited
Peter Askolin, SWEDACPeter Askolin, SWEDAC 1212
Management reviewManagement review
Shall be done periodically by the Shall be done periodically by the laboratory managementlaboratory management
To ensure quality improvements, suitability To ensure quality improvements, suitability and introduce necessary changes.and introduce necessary changes.
Shall be documented Shall be documented
Peter Askolin, SWEDACPeter Askolin, SWEDAC 1313
Corrective actionsCorrective actions
Shall include cause analysisShall include cause analysis Selection and implementation of corrective Selection and implementation of corrective
actionaction Shall be monitoredShall be monitored Additional auditsAdditional audits
Peter Askolin, SWEDACPeter Askolin, SWEDAC 1414
Preventive actionsPreventive actions
Routines to identify needs to improvementRoutines to identify needs to improvement Identify potential sources of non-Identify potential sources of non-
approved methodsapproved methods Own methodsOwn methods Example of an Example of an
accreditation scopeaccreditation scope
Validation of non Validation of non standard methodsstandard methods
SamplingSampling Opinions and Opinions and
interpretationsinterpretations
Measurement uncertaintyMeasurement uncertainty TraceabilityTraceability Reference materialsReference materials Control of dataControl of data
Peter Askolin, SWEDACPeter Askolin, SWEDAC 1616
Choosing methodsChoosing methods
Standard methodsStandard methods Only verification neededOnly verification needed
Modified standard methodsModified standard methods VerificationVerification Validation of modification neededValidation of modification needed
Methods developed by the laboratoryMethods developed by the laboratory Full validation needed for all matricesFull validation needed for all matrices DocumentationDocumentation
Peter Askolin, SWEDACPeter Askolin, SWEDAC 1717
Validation of methodsValidation of methods RequiredRequired Does not need to be preformed by the laboratory Does not need to be preformed by the laboratory
that uses the methodthat uses the method All documentation shall be found at the All documentation shall be found at the
laboratorylaboratory The laboratory has to verify the competence and The laboratory has to verify the competence and
recourses that developed the method.recourses that developed the method. SWEDAC has a document (informative) that SWEDAC has a document (informative) that
helps chemical laboratories in validation. helps chemical laboratories in validation.
Peter Askolin, SWEDACPeter Askolin, SWEDAC 1818
Uncertainty Uncertainty
Laboratory has to Laboratory has to
Identify potential components in uncertaintyIdentify potential components in uncertainty Make an estimation of the uncertaintyMake an estimation of the uncertainty Ensure that the result doesn’t give wrong Ensure that the result doesn’t give wrong
impressionimpression Based on knowledge, validation, experience Based on knowledge, validation, experience
Peter Askolin, SWEDACPeter Askolin, SWEDAC 1919
PersonnelPersonnel
Can be employed or contractedCan be employed or contracted Supervision in introductionSupervision in introduction Basic competency for accredited activitiesBasic competency for accredited activities Job descriptions shall be maintained for all Job descriptions shall be maintained for all
personnel (e.g responsibly for validation)personnel (e.g responsibly for validation)
Peter Askolin, SWEDACPeter Askolin, SWEDAC 2020
Opinions and interpretationsOpinions and interpretations
Shall be based on the resultsShall be based on the results It must be clearly identified It must be clearly identified ProceduresProcedures Technical competenceTechnical competence The big responsibility for opinions and The big responsibility for opinions and
interpretationsinterpretations Not to be mixed with specificationsNot to be mixed with specifications
Peter Askolin, SWEDACPeter Askolin, SWEDAC 2121
SamplingSampling
Can be accredited separatelyCan be accredited separately The laboratory cant automatically exclude The laboratory cant automatically exclude
samplingsampling Will be assessed if the laboratory performs Will be assessed if the laboratory performs
such activities even if not accreditedsuch activities even if not accredited
Peter Askolin, SWEDACPeter Askolin, SWEDAC 2222
Control of dataControl of data
Control of datasets (e.g. Excel datasheets)Control of datasets (e.g. Excel datasheets) Regularly controlled and when changedRegularly controlled and when changed Documented (traceability)Documented (traceability) Validation of software developed by the Validation of software developed by the
Assessed by computer experts if necessaryAssessed by computer experts if necessary
Peter Askolin, SWEDACPeter Askolin, SWEDAC 2323
Accreditation ProcedureAccreditation Procedure
Application from the laboratoryApplication from the laboratory The lead assessor from AB chooses the The lead assessor from AB chooses the
assessment team according to the scopeassessment team according to the scope Documentation will be assessedDocumentation will be assessed Visit to confirm complianceVisit to confirm compliance Laboratory fixes non-compliancesLaboratory fixes non-compliances Decision made by the ABDecision made by the AB
Peter Askolin, SWEDACPeter Askolin, SWEDAC 2424
Flexible scopeFlexible scope
What is a flexible scope?What is a flexible scope? Requirements on the laboratoryRequirements on the laboratory RestrictionsRestrictions Example of a flexible scope accredited by Example of a flexible scope accredited by
SWEDACSWEDAC
Peter Askolin, SWEDACPeter Askolin, SWEDAC 2525
What's this?What's this?
The laboratory can change the scope The laboratory can change the scope without asking permission from ABwithout asking permission from AB
The changes will be audited on the yearly The changes will be audited on the yearly audit visit at the laboratoryaudit visit at the laboratory
Freedom with great responsibilityFreedom with great responsibility Certain limitationsCertain limitations
Peter Askolin, SWEDACPeter Askolin, SWEDAC 2626
RequirementsRequirements
ExperienceExperience Great technical competenceGreat technical competence Personnel pointed out to do validations Personnel pointed out to do validations
and development of methodsand development of methods
Peter Askolin, SWEDACPeter Askolin, SWEDAC 2727
RestrictionsRestrictions
Restricted to methods that are already Restricted to methods that are already used in the laboratory.used in the laboratory.
Laboratory has to have experience in the Laboratory has to have experience in the method used and its limitationsmethod used and its limitations
New methods cant be added to the scopeNew methods cant be added to the scope New methodology cant be introducedNew methodology cant be introduced