peter askolin, m. sc. ( chemistry ) lead assessor at division of chemistry

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


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


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

Management requirements (4§)Management requirements (4§) Technical requirements (5§)Technical requirements (5§)


§4 Management requirements§4 Management requirements

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)


§4 Management requirements§4 Management requirements

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


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


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.


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


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


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


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


Preventive actionsPreventive actions

Routines to identify needs to improvementRoutines to identify needs to improvement Identify potential sources of non-Identify potential sources of non-

conformancesconformances


Technical requirementsTechnical requirements

PersonnelPersonnel Choosing methodsChoosing methods

StandardStandard Modified standards, sector Modified standards, sector

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


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


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.


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


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)


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


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


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

laboratory.laboratory. Electronic signatures (traceablility)Electronic signatures (traceablility)

Assessed by computer experts if necessaryAssessed by computer experts if necessary


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


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


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


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


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


Accredited laboratoriesAccredited laboratories

SWEDACSWEDAC 70 70 Clinical laboratoriesClinical laboratories 32 32 Transfusion medicineTransfusion medicine 34 34 Clinical microbiologyClinical microbiology 8 8 Clinical Clinical

pharmacologypharmacology 55 Clinical physiologyClinical physiology 55 Clinical pathologyClinical pathology 11 Hospital physicsHospital physics

DANAKDANAK Total of 17 accreditation's Total of 17 accreditation's

in laboratory medicinein laboratory medicine 8 8 of them at Statens of them at Statens

Serum instituteSerum institute 2 2 Clinical biochemistryClinical biochemistry 1 1 Private in Clinical Private in Clinical

biochemistry and biochemistry and physiologyphysiology

3 Veterinary laboratories3 Veterinary laboratories 1 Forensic genetics1 Forensic genetics


Thank youThank you

peter askolin, m. sc. ( chemistry ) lead assessor at division of chemistry

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