ISO 17025GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND

CALIBRATING LABORATORIES

When Recognition Matters

WHITEPAPER

www.pecb.com

CONTENT____

Introduction

An Overview of ISO 17025:2005

Key Clauses of ISO 17025:2005 ISO 17025 opposed to ISO 9001

TheBusinessBenefitsofLaboratoryManagement

Why is PECB a Worthy Choice?

StepsforobtainingaPECBCertification

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PRINCIPAL AUTHORSEric LACHAPELLE, PECBBesnik HUNDOZI, PECB

ISO17025//GENERALREQUIREMENTSFORTHECOMPETENCEOFTESTINGANDCALIBRATIONLABORATORIES2

ISO17025//GENERALREQUIREMENTSFORTHECOMPETENCEOFTESTINGANDCALIBRATIONLABORATORIES 3

INTRODUCTION____

Laboratorieshavetocontinuouslyprovidehigh-qualityservicesiftheytendtobesuccessfulinthemarketplace.UsingtheISO17025standardwillassurequalityimprovementandconsistencyinanorganization.

ISO 17025 is the only internationally accepted standard for laboratory quality systems that provides agloballyacceptedbasisforaccreditation.Thefirstversion(ISOGuide25)ofthisstandardwaspublishedin1999,bytheInternationalOrganizationforStandardization(ISO).Thesecondversionwasreleasedin2005,whichismorealignedwiththeISO9001:2000standardregardingqualitysystemwords.

ISO17025:2005specifiesthegeneral requirementsa laboratoryhastomeet if it is toberecognizedascompetent to carry out tests and/or calibrations, including sampling. It covers testing and calibrationperformedusingstandardizedmethods,methodsnotcoveredbystandardizedmethods,andlaboratory-developed methods.

However, compliance with regulatory and safety requirements on the operation of laboratories is notcovered by ISO 17025:2005.

Ifalaboratorywishesaccreditationforpartorallofitstestingandcalibrationactivities,itshouldselectanaccreditation body that operates in accordance with ISO/IEC 17011 (Generalrequirementsforaccreditationbodiesaccreditingconformityassessmentbodies).

ANOVERVIEWOFISO17025ISO/IEC17025 is the global quality standard for testing and calibration laboratories. It is the basis foraccreditation from an accreditation body.

ThisInternationalStandardisapplicabletoallorganizationsperformingtestsand/orcalibrationsregardlessofthenumberofpersonnelortheextentofthescopeoftestingand/orcalibrationactivities.Theseincludefirst-,second-andthird-partylaboratories,andlaboratorieswheretestingand/orcalibrationformspartofinspectionandproductcertification.

There are two main clauses in ISO/IEC 17025:

1. Management requirements – which relate to the operation and effectivenessofthequalitymanagementsystemwithinthelaboratory.2. Technical requirements - which address the competence of staff; testingmethodology;equipmentandquality;andreportingoftestandcalibration results.

ISO 17025 applies to organizations performing tests and/or calibrations that wish to:

1.Establish,implementandmaintainlaboratorymanagementsystem;2.Assureconformitywiththelaboratoriesstatedqualitypolicy;3.Demonstrateconformitytoothers;4.Seekaccreditationofitslaboratorybyanaccreditationbody;and5.Makeaself-determinationandself-declarationofconformitywiththisInternationalStandard.

Thisinternationalstandardisforusebylaboratoriesindevelopingtheirmanagementsystemforquality,administrative and technical operations.

Itcanalsobeusedbylaboratorycustomers,regulatoryauthoritiesandaccreditationbodiestoconfirmorrecognizethecompetenceoflaboratories.

KEYCLAUSESOFISO17025:2005ISO 17025 is organized into the following main clauses:

Clause4:ManagementRequirementsClause5:TechnicalRequirements

Eachofthesekeyactivitiesisoverviewedbelow.

What is Testing?It is the determination of one or more characteristics of an object of conformity assessment,

accordingtoaprocedure.

What is Calibration?Itisanoperationthat,underspecifiedconditions,inafirststep,establishesarelationbetweenthequantityvalueswithmeasurementuncertaintiesprovidedbymeasurementstandardsandcorrespondingindicationswithassociatedmeasurementuncertaintiesand,inasecondstep,usesthisinformationtoestablisharelationforobtainingameasurementresultfroman

indication.

What is a Laboratory?Alaboratoryisanorganizationthat

performs tests and/or calibrations in a permanent, temporary, or remote

location.

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CLAUSE 4: MANAGEMENT REQUIREMENTS

Managementrequirementsrelatetotheoperationandeffectivenessofthequalitymanagementsystemwithinthe laboratory.

Organization–Therolesandresponsibilitiesofthelaboratory,themanagementandkeypersonnelaredefined.

Managementsystem–Thelaboratorymanagementsystemshallbeproperlyimplemented,maintainedandimprovedbasedontheISO17025requirements.

Documentcontrol–Alldocumentsthatarepartofthemanagementsystemareidentified,created,approved,issuedandchangedaccordingtoprocedures.

Reviewofrequests,tendersandcontracts–Therequirementsforrequests,tendersandcontractsaredefined,documented and understood.

Subcontractingoftestsandcalibrations–Thissub-clausedescribehowtoensurethatsubcontractingtestsand/or calibrations are performed by competent subcontractors.

Purchasingservicesandsupplies–Managementshallensurethatpurchasedservicesandsuppliesdonotaffectthequalityoftestand/orcalibrations.

Servicetothecustomers–Thelaboratoryshallcontinuallymeetcustomerrequirements.

Complaints–All complaints received are documented, evaluated and followed up.

Controlofnonconforming testingand/orcalibrationwork–Nonconforming testandcalibration resultsarefollowed up and corrected.

Improvement–Theeffectivenessofthelaboratorymanagementsystemiscontinuallyimproved.

Corrective action – The root cause of nonconformities are identified and adequate corrective actions areselected, implemented, documented and monitored.

Preventiveaction–Preventive actions shall be initiated when potential sources of nonconformities have been identified.

Controlofrecords–Recordsareidentified,availablewhenneeded,andprotectedagainstunauthorizedaccess.

Internal audits – The laboratory shall conduct internal audits periodically to verify compliance with the requirementsofthemanagementsystemandISO17025.

Managementreview–Managementreviewsshallbeconductedtoensuresuitabilityandeffectivenessofthemanagementsystemandtestingand/orcalibrationactivities.

Clause 5: Technical Requirements

Technicalrequirementsrelatetothecompetenceofstaff,samplingandtestingmethodology,equipmentandthequalityandreportingoftestandcalibrationresults.

Personnel – All laboratory personnel that have the highest impact on test and calibration results areadequatelycompetent.

Accommodationandenvironmentalconditions–Thelaboratoryshallensurethatthefacilitiesfortestingand/orcalibrationdonotinvalidateresultsoradverselyaffectthequality.

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Testandcalibrationmethodsandmethodvalidation– Appropriate methods for test and/or calibrations shall be used to ensure accuracy in results.

Equipment – The laboratory shall use appropriate and properly maintained equipment for the correctperformance of tests and/or calibrations.

Measurementtraceability–AllmeasurementsshallbetraceabletotheInternationalSystemofUnits(SI).

Sampling – The laboratory shall implement sampling procedures to ensure that statistically relevantrepresentativesamplesaretakenanddocumented.

Handlingoftestandcalibrationitems–Thelaboratoryshallprotecttheintegrityoftestand/orcalibrationitemsduringtransportation,receipt,handling,storage,retentionand/ordisposal.

Assuringthequalityoftestandcalibrationresults–Thelaboratoryshallcontinuallyensurethequalityofresults.

Reportingofresults–Obtainedresultsshallbeproperlyreportedbyensuringclarityandaccuracy.

ISO17025OPPOSEDTOISO9001Bothstandardshavesimilarrequirementsincludedintheirmanagementsystems.ISO9001isastandardthatspecifiesrequirementsforaqualitymanagementsystem.Itappliestocompaniesdesigning,manufacturing,servicing,calibratingandtesting.

Meanwhile,besidesthefactthatISO17025providestherequirementsforamanagementsystem,italsodeliverstechnicalrequirementsforlaboratoriesperformingtestingand/orcalibrationservices.

THE BUSINESS BENEFITS OF A LABORATORYMANAGEMENTSYSTEM

Aswith allmajor undertakingswithin an organization, it is essential to gain the backing and sponsorship ofexecutivemanagement.Byfarthebestwaytoachievethis,ratherthanthroughhighlightingthenegativeaspectsofnothavingalaboratorymanagementsystemisto illustratethepositivegainsofhavinganeffectivequalitymanagementprocessinplace.

The adoption of an effective laboratory management process within an organization will have many benefits in a number of areas:

• Increaseofconfidenceintestingand/orcalibrationresults;• Better control of laboratory operations;• Potentialincreaseinbusinessduetoenhancedcustomerconfidenceandsatisfaction;• Improvedreputationandimageofthelaboratory;• Nationalandinternationalrecognition;• Continuallyimprovementofqualityandlaboratoryeffectiveness;and• Recognitionoftestingcompetence.

WHY IS PECB A WORTHY CHOICE?

Implementation of LMS with IMS2 methodology

Considering thewelldocumentedbenefitsof implementingaLaboratoryManagementSystembasedon ISO

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17025,makestheproposaleasiertodecideon.

Most organizations now realize that it is not sufficient to implement a generic, “one size fits all” laboratorymanagementplan.Foraneffectiveresponse,withrespecttomaintainingthelaboratorymanagementsystem,suchaplanmustbecustomizedtofittoanorganization.Amoredifficulttaskisthecompilationofanimplementationplanthatbalancestherequirementsofthestandard,thebusinessneedsandthecertificationdeadline.

ThereisnosingleblueprintforimplementingISO17025thatwillworkforeveryorganization,buttherearesomecommonstepsthatwillallowyoutobalancethefrequentconflictingrequirementsandprepareyouforasuccessfulcertificationaudit.

PECBhasdevelopedamethodology(pleaseseeexamplebelow)forimplementingamanagementsystem;the“IntegratedImplementationMethodologyforManagementSystemsandStandards(IMS2)”,andit isbasedonapplicablebestpractices.Thismethodology isbasedon theguidelinesof ISOstandardsandalsomeets therequirementsofISO17025.

1.1 Initiating the LMS

1.2 Understanding the organization

1.3 Analyze the Existing System

1.4 Leadership and Project Approval

1.5 Scope

1.6 Policy

2.1 Organizational Structure

2.2 Document Management

2.3 Design of Controls and Procedures

2.4 Communication

2.5 Awareness and Training

2.6 Resource Management

3.1 Monitoring, Measurement, Analysis and Evaluation

3.2 Internal Audit

3.3 Management Review

4.1 Treatment of Non-conformities

4.2 Continual Improvement

1. Plan 2. Do 3. Check 4. Act

2.7 Customer Management

2.8 Operations Management

MS2isbasedonthePDCAcycledividedintofourphases:Plan,Do,CheckandAct.Eachphasehasbetween2and8stepsforatotalof18steps. In turn, thesestepsaredivided into101activitiesandtasks.ThisPracticalGuide’considersthekeyphasesinyourimplementationprojectfromstarttofinishandsuggeststheappropriate‘bestpractice’foreachone,whiledirectingyourtofurtherhelpfulresourcesasyouembarkon your ISO 17025 journey.

QMS Projects

Plan

Do

Check

Act

4 Phases

21 Steps

101 Activities

Undefined tasks

The sequence of steps can be changed (inversion, merge). For example, the implementation of themanagement procedure for documented information can be done before the understanding of theorganization.Manyprocessesareiterativebecauseoftheneedforprogressivedevelopmentthroughouttheimplementationproject;forexample,communicationandtraining.

Byfollowingastructuredandeffectivemethodology,anorganizationcanbesureitcoversallminimumrequirements for the implementation of a management system. Whatever methodology used, theorganizationmustadaptittoitsparticularcontext(requirements,sizeoftheorganization,scope,objectives,etc...)andnotapplyitlikeacookbook.

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STEPSFOROBTAININGAPECBCERTIFICATION

For organizations: For individuals:

1.Implementthemanagementsystem 1.Participateinthetrainingcourse

2. Perform internal audit and reviews 2.Registerforthecertificationexam

3.Selectpreferredcertificationbody 3.Sitforthecertificationexam

4.Performapre-assessmentaudit(optional) 4.Applyforthecertificationschemeuponsuccessful completion

5.Performthestage1audit 5.Obtaincertification

6.Performthestage2audit(on-site)

7.Performafollow-upaudit(optional)

8.Registerthecertification

9.Assurecontinualimprovementbyconductingsurveillance audits

ForfurtherdetailsrelatingthetypesoftrainingsandcertificationsthatPECBoffers,pleasevisitourwebsite:www.pecb.com

ISO17025//GENERALREQUIREMENTSFORTHECOMPETENCEOFTESTINGANDCALIBRATIONLABORATORIES 9

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