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EGAC Requirements Changes Mohamed Adel Rezk Quality & Develop Manager

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Page 1: 4 Egac System

EGAC RequirementsChanges

Mohamed Adel RezkQuality & Develop Manager

Page 2: 4 Egac System

EGAC Information Packhttp://www.egac.gov.eg/www/InfoCenterCategory.aspx?InfoCenterTypeID=1

Calibration Labs Testing Labs Medical LabsCertification Bodies (QMS,EMS,FSMS,…) Inspection Bodies

PT providers

Contents of each:

• EGAC Application • EGAC Accreditation Agreement• Publications for the field • Regulations for the field• EGAC Accreditation Fee Structure• Scope of EGAC the field

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EGACEGAC

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EGAC Publicationshttp://www.egac.gov.eg/www/InfoCenter.aspx?InfoCenterTypeID=2

List of PublicationsPB01L EGAC Accreditation Process For LaboratoriesPB02C EGAC Accreditation Process For Certification BodiesPB03I EGAC Accreditation Process For Inspection BodiesPB04G EGAC Policy On Traceability For MeasurementsPB05L EGAC Policy On Measurement Uncertainty For Testing

LaboratoriesPB06L EGAC Policy On Measurement Uncertainty For Calibration

LaboratoriesPB07L Guidelines Concerning The Validity Of Calibration CertificatesPB12L EGAC Policy on implementation and use of Proficiency TestingPB13L Guidelines for Uncertainty of measurement in Quantitative

TestingPB14G EGAC Policy on Cross FrontierPB15L Guidelines for Laboratories in Calibration Metrology

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EGAC Publicationshttp://www.egac.gov.eg/www/InfoCenter.aspx?InfoCenterTypeID=2

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PB01L PB01L -- Accreditation Process LabAccreditation Process Lab

•• Benefits of accreditationBenefits of accreditation

•• Who can seek accreditation?Who can seek accreditation?

•• How does ISO 9000 fit with Lab Accreditation?How does ISO 9000 fit with Lab Accreditation?

•• The Accreditation Process / The Accreditation Process / flowchartflowchart

•• The process for Granting accreditationThe process for Granting accreditationoo The Technical Advisory Committee (TAC) meetingThe Technical Advisory Committee (TAC) meeting

oo The Accreditation Committee (AC) meetingThe Accreditation Committee (AC) meeting

oo Decision making and granting accreditationDecision making and granting accreditation

•• Feedback, Complaints and AppealsFeedback, Complaints and Appeals

Accreditation Accreditation ProcessProcess

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Accreditation Accreditation ProcessProcess

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PB04LPB04L ““EGAC Policy EGAC Policy on on TraceabilityTraceabilityof Measurements and Calibrationof Measurements and Calibration””

Accredited Accredited calibration labscalibration labs, shall in all cases:, shall in all cases:•• CalibrateCalibrate critical equipmentcritical equipment and calibrations and calibrations

relevant to the scope of accreditation, relevant to the scope of accreditation, •• Derive theDerive the traceabilitytraceability from direct reference from direct reference

toto Accredited LabsAccredited Labs. . oo or if not available, directly from NMI.or if not available, directly from NMI.oo or reference to SI unit,or reference to SI unit,oo or Calibration Lab that can demonstrate or Calibration Lab that can demonstrate

competence, measurement capability and competence, measurement capability and traceability with appropriate CMC.traceability with appropriate CMC.

•• Has to be confirmed with EGAC Has to be confirmed with EGAC Accreditation Manger on a case by case basis. Accreditation Manger on a case by case basis. ((ILAC P10))

Measurement TraceabilityMeasurement Traceability

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Accredited Accredited Testing labsTesting labs, shall ensure:, shall ensure:•• InIn--house calibration and accredited house calibration and accredited

test/calibration results should be traceable test/calibration results should be traceable to accredited Lab with suitable uncertainty. to accredited Lab with suitable uncertainty.

•• If not available, in sequence If not available, in sequence -- to a National Metrology Institute, to a National Metrology Institute, -- National Reference Laboratory, National Reference Laboratory, -- a Certified Reference Material, a Certified Reference Material, -- Mutual Consent Standard, Mutual Consent Standard,

•• Has to be confirmed with EGAC Has to be confirmed with EGAC Accreditation Manger on a case by case Accreditation Manger on a case by case basis. basis. ((ILAC P10))

PB04LPB04L ““EGAC Policy EGAC Policy on on TraceabilityTraceabilityof Measurements and Calibrationof Measurements and Calibration””

Measurement TraceabilityMeasurement Traceability

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PB05LPB05L ““EGAC Policy on Measurement EGAC Policy on Measurement Uncertainty for Testing LabsUncertainty for Testing Labs””

Testing Laboratories must report uncertainty Testing Laboratories must report uncertainty estimates:estimates:

•• When When specified by the methodspecified by the method, , •• When When required by the clientrequired by the client•• When interpretation of resultsWhen interpretation of results could be compromisedcould be compromised. . Lab Categories:Lab Categories:II-- Qualitative testsQualitative tests for which measurement uncertaintyfor which measurement uncertainty

budgetsbudgets will not be requiredwill not be requiredIIII-- FollowingFollowing WellWell--recognized test methodsrecognized test methods that specifythat specify

major sources of uncertainty & their calculationsmajor sources of uncertainty & their calculationsIIIIII--TestTest methods that require uncertaintymethods that require uncertainty estimates estimates

calculated in accordance with the ISO calculated in accordance with the ISO ““GUM"GUM"

Measurement UncertaintyMeasurement Uncertainty

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In any caseIn any case Laboratories mustLaboratories must know & be able know & be able to showto show the uncertainty associated with a the uncertainty associated with a

measurementmeasurement whether reported or notwhether reported or not. .

Objective evidence of complianceObjective evidence of compliance, reviewed before & , reviewed before & verified during the assessment visit: verified during the assessment visit:

•• ProcedureProcedure for estimating measurement uncertainty, for estimating measurement uncertainty, •• ResultingResulting documented uncertainty estimatesdocumented uncertainty estimates, , •• Trained personnelTrained personnel on measurement uncertainty, and on measurement uncertainty, and •• Supporting informationSupporting information, where relevant, , where relevant,

PB05LPB05L ““EGAC Policy on Measurement EGAC Policy on Measurement Uncertainty for Testing LabsUncertainty for Testing Labs””

Measurement UncertaintyMeasurement Uncertainty

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PB06LPB06L ““EGAC Policy on Measurement EGAC Policy on Measurement Uncertainty for Calibration LabsUncertainty for Calibration Labs””

Uncertainty Estimates are:Uncertainty Estimates are:•• Crucial part to ensure traceability. Crucial part to ensure traceability. •• Calculations in accordance with the GUM.Calculations in accordance with the GUM.•• Expanded uncertainty, coverage factor, confidence Expanded uncertainty, coverage factor, confidence

level.level.•• Calibration certificates with statements of Calibration certificates with statements of

measurement results and uncertainty. measurement results and uncertainty. •• Appropriate, defined, and documented methods to Appropriate, defined, and documented methods to

develop uncertainty estimates.develop uncertainty estimates.•• Good statistical practice and methodology, If cannot, Good statistical practice and methodology, If cannot,

estimation of uncertainty is still required (see GUM).estimation of uncertainty is still required (see GUM).

Measurement UncertaintyMeasurement Uncertainty

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PB07L PB07L –– Guideline onGuideline on Validity of Calibration Validity of Calibration CertificatesCertificates

•• ValidityValidity

•• Expiry date Expiry date ((reference to ILAC GD 24:2007reference to ILAC GD 24:2007))

•• Repaired Repaired

•• Tampering & AbuseTampering & Abuse

•• Excessive Shock Excessive Shock

Calibration GuidanceCalibration Guidance

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EGAC Policy & Procedure for PTEGAC Policy & Procedure for PT

•• PB12LPB12LEGAC Policy EGAC Policy on implementation on implementation and use of and use of Proficiency TestingProficiency Testing

•• P18LP18LAssessment of the LaboratoryAssessment of the Laboratory’’s Participation s Participation

and Performance in and Performance in Proficiency TestingProficiency Testing

Assuring Quality of Test ResultsAssuring Quality of Test Results

Pressure (5000 Ibf/in2) deviation values

-25.000

-20.000

-15.000

-10.000

-5.000

0.000

5.000

10.000

15.000

B022

B023

B024

B025

B026

B027

B028

B029

B030

Ibf/in2

Asigned Value Reported Value Asigned Unc -Asigned Unc 2 SD -2 SD

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Assuring Quality of Test ResultsAssuring Quality of Test Results

PT should coverPT should cover at least one activity in the scopeat least one activity in the scopeof accreditation of the accredited laboratoryof accreditation of the accredited laboratory

The Lab should haveThe Lab should have a plan for the whole scopea plan for the whole scopeof accreditation. It will be requiredof accreditation. It will be required to follow itto follow it..

PT providers have to bePT providers have to be accreditedaccreditedor at leastor at least trusted by EGACtrusted by EGAC

PB12LPB12L -- EGAC Policy on PTEGAC Policy on PT

Disciplines/SubDisciplines/Sub--disciplines ondisciplines on EGAC websiteEGAC website

Med LabsMed Labs have specialhave special PT rulesPT rules. .

Frequency of participation in PT Frequency of participation in PT ≥≥ once/4 years/ once/4 years/ major sub disciplinemajor sub discipline of the scope. of the scope.

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RecordsRecords of PT resultsof PT results accumulated & analyzedaccumulated & analyzedto show the competence & stability of to show the competence & stability of accredited labaccredited lab Acceptable typesAcceptable types of PT in accreditation are:of PT in accreditation are: Bilateral proficiency testingBilateral proficiency testing Proficiency testing schemesProficiency testing schemes ILC designed for other purposesILC designed for other purposes

Take necessaryTake necessary corrective/preventive actioncorrective/preventive action

Results documentedResults documented seen by accreditation seen by accreditation processprocess

Assuring Quality of Test ResultsAssuring Quality of Test Results

PB12LPB12L -- EGAC Policy on PTEGAC Policy on PT

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Additional PT may be required when:Additional PT may be required when: External quality measures are not sufficient,External quality measures are not sufficient, e.g.:e.g.:

* Number of PT performed in specific scopes* Number of PT performed in specific scopes* Extension of the scope of accreditation* Extension of the scope of accreditation* Insufficiently validated in* Insufficiently validated in--house methods house methods

Changes of personnelChanges of personnel in the accredited scopein the accredited scope* Procedural steps deviating from test standard* Procedural steps deviating from test standard

ResultsResults of PT areof PT are unsatisfactoryunsatisfactoryCAsCAs not carried out,not carried out, documented, or sufficientdocumented, or sufficientToTo detect systematic errorsdetect systematic errors in the lab in the lab ToTo provide evidenceprovide evidence on quality/competenceon quality/competence

Assuring Quality of Test ResultsAssuring Quality of Test Results

PB12LPB12L -- EGAC Policy on PTEGAC Policy on PT

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CARsCARs may be Internal/External Quality Measures:may be Internal/External Quality Measures:

Calibration of measuring devices.Calibration of measuring devices. Use of quality control charts.Use of quality control charts. Multiple measurements & statistical methods. Multiple measurements & statistical methods. Use of standard methods for calibration/ testing.Use of standard methods for calibration/ testing. For testing:For testing:

-- use of CRM/calibration/control material.use of CRM/calibration/control material.-- ““blindblind”” test materials (e.g. by Q Manager).test materials (e.g. by Q Manager).

For calibration:For calibration:-- use of Cross Checks & Higher Level calibrations.use of Cross Checks & Higher Level calibrations.

PTsPTs carried out on thecarried out on the laboratory's own initiative.laboratory's own initiative.

Assuring Quality of Test ResultsAssuring Quality of Test Results

PB12LPB12L -- EGAC Policy on PTEGAC Policy on PT

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Internal/External Addition Quality Measures:Internal/External Addition Quality Measures: To repeat the PT.To repeat the PT. To check internal quality assurance measures.To check internal quality assurance measures. To get detailed report on corrective actions.To get detailed report on corrective actions. To make an onTo make an on--site surveillancesite surveillance

Assuring Quality of Test ResultsAssuring Quality of Test Results

PB12LPB12L -- EGAC Policy on PTEGAC Policy on PT

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P18L P18L –– Assessment of Proficiency TestingAssessment of Proficiency Testing

•• Preface Preface

•• Role of EGAC Acc managerRole of EGAC Acc manager

•• Assessment processAssessment process

•• Document review & preliminary assessmentDocument review & preliminary assessment

•• Acceptability Criteria Acceptability Criteria

•• Assessment of results Assessment of results

•• Corrective actions and additional measures Corrective actions and additional measures

Procedures for Lab AccreditationProcedures for Lab Accreditation

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Document review &Preliminary assessment

Set Criteria

Plan is place and covering the whole scope?

Yes

Check Results

Documentsavailable & sufficient?

No

criteria adequate?

YesNo

Yes

12

No

Assuring Quality of Test ResultsAssuring Quality of Test Results

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Acceptable?

Satisfactory?EndYes

No

Explanation &corrective actions 

available?

No

YesYesEnd

Additional measures

Measuresare positive?End

Yes

No

Restriction of the scope of accreditation, eventually suspension or withdrawal of accreditation.

1

2

Assuring Quality of Test ResultsAssuring Quality of Test Results

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PB13LPB13L Guidelines on Calculation of Guidelines on Calculation of Measurement Uncertainty for Testing LabsMeasurement Uncertainty for Testing Labs

Factors contributing to UncertaintyFactors contributing to Uncertainty

Correction due to systematic effectsCorrection due to systematic effects

Definition of the Definition of the measurandmeasurand

SamplingSampling

Handling of SamplesHandling of Samples

Preparation of samplesPreparation of samples

Environmental and measurement conditionsEnvironmental and measurement conditions

PersonnelPersonnelVariations in the test procedureVariations in the test procedure

Measuring InstrumentsMeasuring Instruments

Calibration Standards or Reference MaterialsCalibration Standards or Reference Materials

Software / Methods of measurementSoftware / Methods of measurement

Measurement UncertaintyMeasurement Uncertainty

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Guidance on implementationGuidance on implementation

Fundamental PointsFundamental Points::A. The statement of uncertaintyA. The statement of uncertainty contain contain

sufficient informationsufficient information for comparisons;for comparisons;B.B. Use GUMUse GUM andand sector specific interpretationssector specific interpretations;;C.C. OnlyOnly uncertainty of measurement inuncertainty of measurement in

quantitative testing for nowquantitative testing for now. . Qualitative testing Qualitative testing is developing;is developing;D. An estimation ofD. An estimation of overall uncertaintyoverall uncertainty, , oror identification of identification of

majormajor componentscomponents withwith estimate of size of combined estimate of size of combined uncertaintyuncertainty;;

E.E. UseUse existingexisting knowledgeknowledge / / Experimental dataExperimental data (quality control (quality control charts, validation, round robin tests, PT, CRM, handbooks charts, validation, round robin tests, PT, CRM, handbooks etc.);etc.);

PB13LPB13L Guidelines on Calculation of Guidelines on Calculation of Measurement Uncertainty for Testing LabsMeasurement Uncertainty for Testing Labs

Measurement UncertaintyMeasurement Uncertainty

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Guidance on implementationGuidance on implementation

Fundamental PointsFundamental Points::F. When using aF. When using a Std Test MethodStd Test Method there are three cases: there are three cases:

-- If it hasIf it has guidance to uncertainty evaluationguidance to uncertainty evaluation, follow;, follow;-- If it givesIf it gives typical uncertaintytypical uncertainty, comply & quote it;, comply & quote it;-- If itIf it implicitly includes uncertaintyimplicitly includes uncertainty, just quote it;. , just quote it;.

G.G. FactorsFactors to be taken into account:to be taken into account:-- Common senseCommon sense;;-- InfluenceInfluence of uncertainty of measurementof uncertainty of measurement on resulton result;;-- Degree of rigorDegree of rigor in determination of uncertainty.in determination of uncertainty.

H. In certain cases it can be sufficient toH. In certain cases it can be sufficient to report only reproducibilityreport only reproducibility;;I.I. WhenWhen estimation of uncertainty isestimation of uncertainty is limitedlimited itit should be made clearshould be made clear;;

PB13LPB13L Guidelines on Calculation of Guidelines on Calculation of Measurement Uncertainty for Testing LabsMeasurement Uncertainty for Testing Labs

Measurement UncertaintyMeasurement Uncertainty

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Procedures for the evaluation of the result uncertaintyProcedures for the evaluation of the result uncertainty

Quantitative test resultQuantitative test result

Qualitative test resultQualitative test resultBased on quantitative attribute values Based on quantitative attribute values

Based on qualitative attribute values Based on qualitative attribute values

PB13LPB13L Guidelines on Calculation of Guidelines on Calculation of Measurement Uncertainty for Testing LabsMeasurement Uncertainty for Testing Labs

Measurement UncertaintyMeasurement Uncertainty

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A. ISO “International Vocabulary of Basic and General Terms in Metrology”(VIM) 2nd ed. 1993, ISBN 92-67-10175-1

B. ISO “Guide to the Expression of Uncertainty in Measurement” (GUM): 1993 (revised 1995), ISBN 92-67-10188-9

C. ISO 5725 (Part 1 – 6):1994 Accuracy (trueness and precision) of measurement methods and results (n.b. Part 5 is 1998)

D. ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories

E. ILAC G17: 2002: Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 17025.

F. CITAC / Eurochem “Guide to Quality in Analytical Chemistry”: 2002. (see www.eurachem.org)

G. EA-4/16: 2003 “Guidelines on the expression of Uncertainty in Quantitative Testing”. (see www.european-accreditation.org)

H. APLAC TC 005:2004 “Interpretation and guidance on the estimation of uncertainty of measurement in testing”; Asian Pacific Lab. Acc. Cooperation. (see www.aplac.org)

I. UKAS LAB 34: 2003: The Expression of Uncertainty in EMC Testing; United Kingdom Accreditation Service. (see www.ukas.org)

PB13LPB13L (References)Measurement UncertaintyMeasurement Uncertainty

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PB14GPB14G EGAC Policy on Cross FrontierEGAC Policy on Cross Frontier

Cross FrontierCross Frontier

In general EGAC complies with the Guidance documents on cross frontier from :

• IAF – (GD3:2003).• ILAC – (G21:2002).

In general EGAC complies with the Guidance documents on In general EGAC complies with the Guidance documents on cross frontier from :cross frontier from :

•• IAF IAF –– (GD3:2003).(GD3:2003).•• ILAC ILAC –– (G21:2002). (G21:2002).

in the following situations: When EGAC performs

accreditation for a CAB located outside Egypt.

When an MRA/MLA signatory international Accreditation Body performs accreditation for a CAB located inside Egypt.

in the following situations:in the following situations: When EGAC performs When EGAC performs

accreditation for a CAB located accreditation for a CAB located outside Egypt.outside Egypt.

When an MRA/MLA signatory When an MRA/MLA signatory international Accreditation international Accreditation Body performs accreditation Body performs accreditation for a CAB located inside Egypt.for a CAB located inside Egypt.

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PB15L – Guidelines for Laboratories in Guidelines for Laboratories in Calibration MetrologyCalibration Metrology

Calibration GuidanceCalibration Guidance

Dimension, Temperature, Force, Electrical

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EGAC RegulationsEGAC EGAC RegulationsRegulations

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EGAC RegulationsEGAC EGAC RegulationsRegulations

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R01L R01L –– Regulations for Conformity Assessment bodiesRegulations for Conformity Assessment bodies

•• Accreditation Criteria Accreditation Criteria •• Conditions for Conformity Assessment Bodies:Conditions for Conformity Assessment Bodies:

oo GeneralGeneraloo For Certification BodiesFor Certification Bodiesoo For Inspection BodiesFor Inspection Bodiesoo For Calibration / TestingFor Calibration / Testing LaboratoriesLaboratories

•• Significance of Accreditation Significance of Accreditation •• Notification of changeNotification of change•• Suspension & withdrawalSuspension & withdrawal•• Appeals Appeals •• Complaints Complaints

EGACEGAC’’ss RegulationsRegulations

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R02G R02G –– Measurement & Calibration Systems Measurement & Calibration Systems

•• PlaningPlaning & Selection of Equip./Ref. Materials & Selection of Equip./Ref. Materials ((ILACILAC--G9:2005G9:2005)

•• Uncertainty of measurement Uncertainty of measurement ((ILACILAC--G17:2002G17:2002))

•• Calibration procedures Calibration procedures

•• RecordsRecords

•• Calibration IntervalsCalibration Intervals ((ILAC G24:2007ILAC G24:2007))

•• Sealing of Calibrated EquipmentSealing of Calibrated Equipment

•• Labeling of Calibrated Equip./Ref. MaterialLabeling of Calibrated Equip./Ref. Material

EGACEGAC’’ss RegulationsRegulations

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R03G R03G –– Accreditation Accreditation Fee StructureFee Structure

•• Application feesApplication fees

•• Document review feesDocument review fees

•• Assessment visits: Assessment visits: oo prepre--assessment assessment

oo initial assessmentinitial assessment

oo followfollow--up up

•• Surveillance / extension of scopeSurveillance / extension of scope

•• Administration fees: Administration fees: administrative, and subsistence administrative, and subsistence expensesexpenses

EGACEGAC’’ss RegulationsRegulations

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R04G R04G –– Use of EGAC SymbolUse of EGAC Symbol

•• General Format & DisplayGeneral Format & Display•• Use of Symbol by LaboratoriesUse of Symbol by Laboratories•• Use on Calibration Certificates & Labels Use on Calibration Certificates & Labels •• Use on Test Reports & Certificates Use on Test Reports & Certificates •• Use on QMS CertificatesUse on QMS Certificates•• Use on EMS CertificatesUse on EMS Certificates•• Use on Publicity MaterialsUse on Publicity Materials•• Other Restrictions & SanctionOther Restrictions & SanctionCorrective ActionsCorrective Actions -- Withdrawal of certificatesWithdrawal of certificates,,Publication of transgressionPublication of transgression -- SuspensionSuspension // withdrawal of accreditation withdrawal of accreditation and / orand / or legal actionlegal action

•• Appendices: Appendices: –– 1: Symbol display 1: Symbol display –– 2: Symbol Design examples 2: Symbol Design examples –– 3: Calibration Label design, use and control 3: Calibration Label design, use and control

EGACEGAC’’ss RegulationsRegulations

TestingCAB # 206024

Accredited body’s mark

Page 36: 4 Egac System

•• Grading of nonconformities in EGACGrading of nonconformities in EGAC Very seriousVery serious credibility of the accreditation program is seriously threatenedcredibility of the accreditation program is seriously threatened

Quite significantQuite significant validity or integrity of EGAC is threatened validity or integrity of EGAC is threatened

Minor / isolatedMinor / isolated does not affect the core activities of the CAB does not affect the core activities of the CAB

•• Actions taken by EGAC according to nonconformity gradeActions taken by EGAC according to nonconformity grade Actions of EGAC according to NC gradeActions of EGAC according to NC grade

According to seriousness:According to seriousness:•• Very seriousVery serious rejection in initial assessment or immediate rejection in initial assessment or immediate

suspension in surveillance/reassessmentsuspension in surveillance/reassessment•• Quite significantQuite significant CA must be completed within the specifiedCA must be completed within the specified

time interval as in tabletime interval as in table•• Minor / isolatedMinor / isolated nonnon--conformity noted in the assessment notesconformity noted in the assessment notes

R05G R05G -- Accreditation Process Time Limitations and Accreditation Process Time Limitations and Response Actions to the Nonconformities of the CABsResponse Actions to the Nonconformities of the CABs

EGACEGAC’’ss RegulationsRegulations

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R05G R05G -- Accreditation Process Time LimitationsAccreditation Process Time LimitationsEGACEGAC’’ss RegulationsRegulations

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Who Accredit Accrediting Bodies?Who Accredit Accrediting Bodies?NOT accredit but recognizeNOT accredit but recognize

International GroupInternational GroupILACILAC

International Laboratory Accreditation CooperationInternational Laboratory Accreditation Cooperation

Regional GroupsRegional GroupsEAEA

European Cooperation for AccreditationEuropean Cooperation for AccreditationAPLACAPLAC

Asia Pacific Laboratory Accreditation ConferenceAsia Pacific Laboratory Accreditation ConferenceIAACIAAC

Inter American Accreditation CooperationInter American Accreditation Cooperation

Page 39: 4 Egac System

ILAC / IAF Joint Documents

ILAC / IAF Joint ILAC / IAF Joint DocumentsDocuments

Page 40: 4 Egac System

IAF-ILAC Joint Publication (A Series)http://www.ilac.org/ilaciafjoint.html

IAF/ILAC A3:05/2007 IAF/ILAC MRAs: Key Performance Indicators - A Tool for the Evaluation Process

IAF/ILAC A5:03/2011 IAF/ILAC MLA/MRA: Application of ISO/IEC 17011:2004

Page 41: 4 Egac System

IAF-ILAC Joint Publication (A Series)http://www.ilac.org/ilaciafjoint.html

IAF/ILAC A3:07/2011 Narrative Framework for Reporting on the Performance of an Accreditation Body – A Tool for the Evaluation Process

(1) to allow an evaluated accreditation body (AB) to present information about how it addresses ISO 17011 requirements;

(2) to focus the evaluation agenda on important topics;

Page 42: 4 Egac System

IAF-ILAC Joint Publication (A Series)http://www.ilac.org/ilaciafjoint.html

IAF/ILAC A5:03/2011 IAF/ILAC MLA/MRA: Application of ISO/IEC 17011:2004

The purpose of this document is to enable accreditation bodies to better harmonize their

application of the standards against which they assess conformity

assessment bodies (CABs).

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ILAC DocumentsILAC ILAC DocumentsDocuments

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ILAC Procedural Series (P Series)http://www.ilac.org/procseries.html

ILAC P9:2005 ILAC Policy for Participation in National and International Proficiency Testing Activities

ILAC P10:2002 ILAC Policy on Traceability of Measurement Results

ILAC P13:2010 Application of ISO/IEC 17011 for the Accreditation of Proficiency Testing Providers

ILAC P14:12/2010 ILAC Policy for Uncertainty in Calibration (calculating & expressing CMC)

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ILAC P10ILAC Policy on Traceability of Measurement

Results

Calibration/Traceability of critical equipment &

use of CRM

Traceability to NMI or accredited Laboratory

with suitable Uncertainty

ILAC ProceduresILAC Procedures

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ILAC P9ILAC Policy for participation in National & International Proficiency Testing Activities

One activity prior to accreditation

A plan for the participation in the PT schemes for the

whole scope

ILAC ProceduresILAC Procedures

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ILAC Guidance Documents (G Series)http://www.ilac.org/guidanceseries.html

ILACILAC--G9:2005G9:2005 Guidelines for the Selection and Use of Certified Reference Materials

ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers

ILAC-G13:2007 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes

ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 17025

ILAC-G20:2002 Guidelines on Grading of Non-ConformitiesILAC-G22:2004 Use of Proficiency Testing as a Tool for Accreditation

in Testing ILAC-G24:2007 Guidelines for the determination of calibration

intervals of measuring instrumentsILAC-G25:2012 Accreditation of Proficiency Testing Providers to

ISO/IEC 17043:2010 - A Crosswalk to ILAC G13:2007

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ILAC Guidance Documents (G Series)http://www.ilac.org/guidanceseries.html

ILAC-G9:2005 Guidelines for the Selection and Use of Certified Reference Materials

These guidelines aim at establishing the framework

by which laboratories seeking accreditation, and technical assessors, will be

able to propose and evaluate the CRMs relevant to their

specific needs.

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ILAC Guidance Documents (G Series)http://www.ilac.org/guidanceseries.html

ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers

These Guidelines have been developed for evaluation of the

competence of reference materials producers with a view to the eventual establishment of internationally accepted criteria.

This document is intended as a guide to ISO Guide 34.

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ILAC Guidance Documents (G Series)http://www.ilac.org/guidanceseries.html

ILAC-G13:08/2007 Guidelines for the Requirements forforthe Competence of Providers of Proficiency Testing Schemes

This document is for providers of proficiency testing schemes who wish to demonstrate their competence by formal compliance with a set of internationally-acceptable requirements for the

planning and implementation of proficiency testing schemes.

There is an ISO document under development ISO 170

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ILAC Guidance Documents (G Series)http://www.ilac.org/guidanceseries.html

ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 17025

This document describes how the concept of uncertainty of

measurement should be introduced taking into account present state of the art understanding. It is realized

that during the course of the implementation of ISO/IEC 17025,

suitable sector-specific guidance will be needed.

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ILAC Guidance Documents (G Series)http://www.ilac.org/guidanceseries.html

ILAC-G20:2002 Guidelines on Grading of Non-Conformities

This document outlines one approach to grading non-

conformities, from more to less serious, through linking

the seriousness of the nonconformity with the

actions that the accreditation body may need to take. Some

examples of the various grading are listed.

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ILAC Guidance Documents (G Series)http://www.ilac.org/guidanceseries.html

ILAC-G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing

The objective of this document is to ensure a consistent good practice for Accreditation Bodies and laboratories in the cost-effective use of proficiency testing in

accreditation.

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ILAC Guidance Documents (G Series)http://www.ilac.org/guidanceseries.html

ILAC-G24:2007 Guidelines for the determination of calibration intervals of measuring instruments

The purpose of this document is to give laboratories, particularly while setting up their

calibration system, guidance on how to determine calibration intervals. This document identifies

and describes the methods that are available and known for the evaluation of calibration intervals.

Page 55: 4 Egac System

Thank you