Guide25toISO/IEC17025:

ABriefHistoryandIntroduction
DanielD.Hoolihan
Hoolihan EMC Consulting
HoolihanEMCConsulting
April2010
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
Gu
Guide25andISO/IEC17025areinternational
de 5 a d SO/ C 0 5 a e te at o a
documentsthatspecifyrequirementsthattesting
laboratoriesshouldmeettobehighquality
l b
laboratories
ThedocumentscamefromtheInternational
St d d
Standardsarenaandmanycountriescontributed
d ti t ib t d
tothematerialinthepublications
Productacceptancearoundtheworldisbasedon
Product acceptance around the world is based on
testresultsfromaccreditedlaboratories
LaboratoriesareaccreditedtoISO/IEC17025
Laboratories are accredited to ISO/IEC 17025
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
The
Theaveragepersonexpectstobuyproducts
average person expects to buy products
thatworkthewaytheyareadvertised
Thelabaccreditationprocessinconcertwith
The lab accreditation process in concert with
manufacturerswhotestproductsto
standards permits the average consumer to
standards,permitstheaverageconsumerto
beconfidentintheproductstheybuy
So,everyonebenefitsfromahighquality
S b fi f hi h li
laboratoryaccreditationsystem
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
ISOGuide25:1978
ISO Guide 25: 1978 FirstEdition
First Edition
ISO/IECGuide25:1982 SecondEdition
ISO/IECGuide25:1990
SO/ C G id 2 990 ThirdEdition
hi d di i

TheEuropeanversionofGuide25was
p
EuropeanStandardEN45001:1989
GeneralCriteriafortheOperationofTesting
Laboratories.
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
HistoryofISO/IEC17025 GeneralRequirementsfortheCompetenceof
Testing and Calibration Laboratories
TestingandCalibrationLaboratories

ISO/IEC17025andISO/IECGuide25werepreparedbytheInternational
g ( ) y
StandardsOrganization(ISO)CommitteeonConformityAssessmentwhich
isrepresentedbytheacronym CASCO.
IECistheInternationalElectrotechnical Commission.

ISO/IEC 17025 1999 FirstEdition

ISO/IEC17025:1999 Fi t Editi releasedinDecemberof1999
l di D b f 1999
TheFirstEditionofISO/IEC17025cancelledandreplacedISO/IECGuide
25:1990.

ISO/IEC17025:2005 SecondEdition
releasedinMayof2005
thisisthelatestEdition
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
In
Inthe1990s,therelevantdocumentforlab
the 1990s the relevant document for lab
accreditationwasISO/IECGuide25,"General
Requirements for the Competence of Testing
RequirementsfortheCompetenceofTesting
andCalibrationLaboratories.
Reflectingtheincreasingworldwide
Reflecting the increasing worldwide
importanceofthissubject,Guide25was
revised as ISO/IEC 17025 with the same title
revisedasISO/IEC17025withthesametitle.
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
Ingeneral,therequirementsinthe17025
ge e a , t e equ e e ts t e 0 5
standard aremoremandatoryinnaturethanthe
recommendationsofGuide 25
Theorganizationofthe17025standardhas
changedtoreflectthisdifference.
Thatis,themainbodyofthestandardisdivided
intothreeparts:
initialrequirements,
i iti l i t
managementrequirements,and
technicalrequirements.
technical requirements
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
TheISO/IEC170252005Standardisasuccessortothe
/
1999versionofthesamenumberedstandard.
The1999versionwasafollowontotheearlierGuide
25 d
25document. t
Unfortunately,oneyearafterthe1999versionof
17025 was released; the ISO 9000 series of standards
17025wasreleased;theISO9000seriesofstandards
changed!
So,itthentooktheinternationalstandards
organization(anditsworkinggroupon17025)almost6
yearstobringouttherevised17025in2005.
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
NOTE
NOTE thestandardiswritteninageneral
the standard is written in a general
fashionforalltypesoflaboratories(chemical,
biological environmental etc ) but this
biological,environmental,etc.)butthis
presentationapproachesthesubjectfroman
EMC Lab perspective
EMCLabperspective.
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
The
The1999versionwasabigimprovementover
1999 version was a big improvement over
theGuide25documentbecauseitdividedthe
labrequirementsintoManagementCriteria
andTechnicalCriteria.
TheManagementportionofthestandardwas
verysimilartoISO9000.
TheTechnicalportionaddressedthetechnical
detailsofbothtesting andcalibration
laboratories.
 Management Requirements
ManagementRequirements
4.1 Organization
4.2 ManagementSystem
4.3 DocumentControl
4.3.1
431 General
4.3.2 DocumentApprovalandIssue
4.3.3 DocumentChanges
44.4
4 R i
ReviewofRequests,Tenders,
fR t T d
andContracts
4.5 SubcontractingofTestsand
Calibrations
lib i
4.6 PurchasingServicesand
Supplies
pp
 Management Requirements
ManagementRequirements
4.7 ServicetotheCustomer
4.8 Complaints
4.9 ControlofNonconforming
Testing and/or Calibration Work
Testingand/orCalibrationWork
4.10 Improvement(onlynewClausein2005edition)
4.11 CorrectiveAction
4.11.1 General
4.11.2 CauseAnalysis
4.11.3 SelectionandImplementationof
p
CorrectiveActions
4.11.4 MonitoringofCorrectiveActions
4.11.5 AdditionalAudits
 Management Requirements
ManagementRequirements
4.12 PreventiveAction
Preventive Action
4.13 ControlofRecords
4.13.1 General
4.13.2 TechnicalRecords
4.14 InternalAudits
4.15 ManagementReviews
 Technical Requirements
TechnicalRequirements
5.1 General
5.2 Personnel
5.3 Accommodationand
Environmental
Environmental Conditions
5.4 TestandCalibrationMethodsand
MethodValidation
5.4.1 General
5.4.2 SelectionofMethods
5.4.3 LaboratoryDevelopedMethods
5.4.4 NonStandardMethods
5.4.5 ValidationofMethods
5.4.6 EstimationofUncertaintyofMeasurement
5.4.7 ControlofData
 Technical Requirements
TechnicalRequirements
5.5 Equipment
q p
5.6 MeasurementTraceability
5.6.1 General
5.6.2
562 S ifi R
SpecificRequirements
i
5.6.3 ReferenceStandardsandReference
Materials
5.7 Sampling
5.8 HandlingofTestandCalibration
Items
5.9AssuringtheQualityofTestandCalibration
Results
 Technical Requirements
TechnicalRequirements
5.10 ReportingtheResults
p g
5.10.1General
5.10.2TestReportsandCalibrationCertificates
5 10 3 Test Reports
5.10.3TestReports
5.10.4CalibrationCertificates
5.10.5OpinionsandInterpretations
5.10.6TestingandCalibrationResultsObtainedfromSubcontractors
5.10.7ElectronicTransmissionofResults
5.10.8FormatofReportsandCertificates
p
5.10.9AmendmentstoTestReportsandCalibrationCertificates
 Guide 25 to ISO/IEC 17025
Guide25toISO/IEC17025
ISO/IEC17025(anInternationalStandard)wasabig
/ ( ) g
improvementoverISO/IECGuide25
SplittingtheManagementRequirementsandthe
T h i lR
TechnicalRequirementswasamajorstep
i t j t
ISO/IEC17025iswidelyacceptedaroundtheworld
The
ThenexteditionofISO/IEC17025isbeingdiscussed
next edition of ISO/IEC 17025 is being discussed
becauseithasbeenfiveyearssincethereleaseofEdition
2
FFutureimprovements
t i t splittingthestandardintotwo
litti th t d d i t t
onefortestinglabsandoneforcalibrationlabs