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NLA Conference : 09 October 2013
Steps the chemical laboratory should follow to prepare for an ISO/IEC 17025 technical assessment
Chris Fouché
( Laboratory Quality Cure(Pty) Ltd)
www.labqualitycure.co.za
NLA Conference : 09 October 2013
Two types of Assessments:
Management requirements
Technical requirements
NLA Conference : 09 October 2013
Management Requirements:
Quality DocumentationSub clauses 4.1 to 4.15
(Organization, Complaints to Management review)
NLA Conference : 09 October 2013
Technical Requirements:
Quality DocumentationSub clauses 5.1 to 5.10
(General, Equipment to Reporting of results)
NLA Conference : 09 October 2013
Technical Assessment:
Witnessing( F15)
Vertical(F44)
General Technical (F49)
NLA Conference : 09 October 2013
Witnessing Activity(F15):
EquipmentCalibration StandardsQuality Control StandardsMethod ValidationUncertainty of measurementProficiency TestingQuality Control ChartsCompetenceEnvironmental Conditions
Witnessing quality verification:
Laboratory water qualityGlassware volume-GradingBalanceCalibrationDaily verificationTemperatureThermometersOvensFurnacesWaterbaths
NLA Conference : 09 October 2013
Vertical Assessment(F44):
Report traceability
Technical Signatory
NLA Conference: 09 October 2013
Vertical Traceability:Data transferTraining competenceMethod validationAssurance of results( QC)Proficiency TestingCalibration StandardsEquipment calibrationAccommodationLaboratory consumablesTest item handlingReporting of results
NLA Conference: 09 October 2013
Non Conformance(F03):Detailed observationClassification-Major/MinorSub clause referenceSignatures :
Laboratory staffLead/ Technical Assessor
Corrective ActionRoot CausePreventative ActionTime frame NC-25 working daysTechnical Assessor clearanceNext assessment clearance
NLA Conference: 09 October 2013
Recommendation Report(F04):Continued accreditationScope of accreditationEffective clearance of NCPositive & negative aspects around qualityDifferent assessments:
Pre- assessmentFull assessment(5y cycle)Surveillance (18months x 2)
NLA Conference: 09 October 2013
Acceptance Approvals Committee:
Final evidence of all data verification
Final approval by Technical/ Lead assessor
Final approval by Field Programme Manager
Updated scope of accreditation certificate
NLA Conference: 09 October 2013
Conclusion:
Recommendation & Approval:
MethodsTechnical SignatoryFinal Accreditation StatusSANAS laboratory reference T number
NLA Conference: 09 October 2013
References:
ISO/IEC 17025www.sanas.co.zawww.labqualitycure.co.zaSANAS R03- Technical Signatory RequirementsSANAS R04- Logo requirementsSANAS P30-Scope of testingSANAS R51- Suspension statusSANAS R80-Proficiency TestingSANAS TG07-Method Validation
NLA Conference: 09 October 2013
