Design Specification for an Amendment to ISO 9001.docx
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Design Specification for an Amendment to ISO 9001.docx
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DesignSpecificationforanAmendmenttoISO9001
Document:
ISO/TC176/SC2/N730
Ourref
SecretariatofISO/TC176/SC2Date:
30June2005
TotheMembersof
ISO/TC176/SC2-
QualityManagementand
QualityAssurance/
QualitySystems
DesignSpecificationforanAmendmenttoISO9001:
2000
PleasefindattachedacopyoftheaboveDesignSpecification.
InaccordancewiththerecommendationsofISOGuide72,thisDesignSpecificationisbeingcirculatedtothemembersofISO/TC176/SC2forballot,todetermineifthereisapprovalforthebasisofthiswork,priortothestartofanydraftingworkfortheamendment.
Pleasereturnaballotresponseofeither:
Approval,DisapprovalorAbstain,before:
30September2005
Thankingyouinanticipation.
Yourssincerely
CharlesCorrie
FortheBSISecretariatof
ISO/TC176/SC2
Contents
1.Introduction
2.Userneedsandevaluationofimpactsandbenefits
3.Purposeandscopeoftheamendment
4.Scope,purpose,title,fieldofapplicationoftherevisedstandardandguidingprinciples
5.Compatibility
6.Consistency
7.Modelanditsfeatures
8.Structureofthestandard
9.Subjectstobeaddressedinthetextoftheamendedstandard
10.Guidanceondrafting
11.Liaisons
AppendixA:
Listofreferenceinputdocuments
AppendixB:
Toolforassessingtheimpactsversusbenefitsofproposedchanges
0.Introduction
In2004ISO/TC176/SC2conductedaformalSystematicReviewofISO9001:
2000amongstitsmembers,todetermineifitshouldbewithdrawn,leftunchanged,amendedorrevised.Byalargemajority,theresponsewasthatitshouldbeamended.
InparallelwiththeSystematicReview,ISO/TC176/SC2alsoconductedanextensiveISO9001:
2000andISO9004:
2000UserFeedbackSurvey.
InaccordancewiththerecommendationsofISO/Guide72:
2001Guidelinesforthejustificationanddevelopmentofmanagementsystemstandards,ISO/TC176/SC2thenpresentedaJustificationStudytoISO/TC176,todemonstratethattherewassufficientevidenceoftheneedforanamendmenttobedeveloped.
Followingdiscussionsduringitsplenarymeetingsheldin2004,ISO/TC176endorsedtherecommendationsoftheJustificationStudyandresolvedthataprojectshouldbeundertakenforalimitedamendmenttoISO9001:
2000.
ThisDesignSpecificationtranslatestheoutputsoftheseeventsintorequirementsforproducingtheamendment.
ISOGuide72alsorecommendsthataDesignSpecificationisapproved,priortodraftingofthestandardcommencing;consequently,thisDesignSpecificationwillbecirculatedtothemembersofISO/TC176/SC2forreviewandforballot.
ThisDesignSpecificationwillbeusedtoguidetheISO/TC176/SC2expertsinthedraftingoftheamendmenttoISO9001,andwillalsobeusedasthetemplateforverifyingtheoutputsofthedraftingprocess.
1.Userneedsandevaluationofimpactsandbenefits
TheJustificationStudyidentifieduserneedsfromthefollowing:
∙theresultsoftheSystematicReviewthatwascompletedonISO9001:
2000during2003-2004(ISO/TC176/SC2document:
N676R),
∙thefeedbackfromISO/TC176/WGInterpretations(ISO/TC176/SC2document:
N683R),
∙theextensiveworldwideISO/TC176/SC2/WG18ISO9001andISO9004UserFeedbackSurvey(ISO/TC176/SC2document:
N681),andsimilarnationalsurveys,
ReferencewasalsomadetotheoriginaldesignspecificationforISO9001(ISO/TC176/SC2document:
N307),whichidentifiedusersanduserneeds.
TheabovedocumentsandotherinputstotheamendmentprocesshavebeenlistedinAnnexA.
TheJustificationStudyalsomadeuseoftheoutputoncompatibilityprovidedbytheISO/TC176/SC2andISO/TC207/SC1JointTaskGrouponCo-ordination(theJTG)asanimportantsourceforuserneeds.RequirementsarisingfromthatfeedbackareaddressedinSection4.0Compatibility.
Theaboveinputshavebeenreviewedandtakenaccountofduringthepreparationofthisdesignspecification(seeSection8.0).
Theseinputshighlightedthatinordertosatisfyuserneeds,theamendedstandardshallremaingenericandbeapplicabletoallsizesandtypesoforganizationoperatinginanysector.Howeveritwasalsonotedthat:
∙Thesamplesizeandthegeographicrepresentationoftheresponsesinthecommentsandsurveyswerelimited.
∙ThetotalnumberofcommentsonspecificsectionsofthestandardintheISO9001andISO9004UserFeedbackSurveywassometimessmallcomparedwiththetotalnumberofsurveyresponses.
∙Thelimitednumberofinterpretationsmaynotberepresentativeoftheneedforclarificationbyalltheusersofthestandard.
∙Thedevelopmentoftheamendedstandardwillaffectassociatedmanagementsystemstandards
TheJustificationStudy,byrestrictingthechangesinISO9001tothelevelofanamendment,requiresthattheimpactontheusersofthisstandardshallbelimited,andalsothatchangeswillonlybeintroducedwherethereareclearbenefitstousers.Consequently,analysesofthepotentialimpactsandbenefitsarisingfromproposedchangeswillbeundertakenusingthetooldescribedinAnnexB.
2.Purposeandscopeoftheamendmentprocess
2.1Purpose
ThepurposeoftheamendmentistoenhancetheclarityofISO9001:
2000andtoenhanceitscompatibilitywithISO14001:
2004.
2.2Scope
Thefollowingrequirementsshallapplytotheamendmentprocess:
∙ThemodelandprocessapproachshallbemaintainedasdefinedinISO9001:
2000(seeSections6.0Modeland7.0Structure).
∙Theamendedstandardshallremaingenericandbeapplicabletoallsizesandtypesoforganizationoperatinginanysector.
∙ThecompatibilitywithISO14001:
2004shallbemaintainedandbeenhanced,ifpossible.
∙TheconsistencybetweenISO9001andISO9004shallbemaintained(seeSection5.0).
∙Thechangesshallberestrictedsothattheimpactoftheamendmentontheusersislimited,andalsothatchangeswillonlybeintroducedwherethereareclearbenefitstousers(seeSection8andAnnexB)
∙TheISO9001:
2000supportpackageshouldbeusedtoassistthewritersinidentifyingissuesforclarification.
∙Draftsoftheamendedstandardshallbesubjectedtoverificationagainstthedesignspecification,andtovalidationbyusers
3.Scope,purpose,titleandfieldofapplicationoftheamendedstandardandguidingprinciples
Thecurrentscopeandpurposeofthestandard,thetitleandthefieldofapplicationshallbeunchangedfromISO9001:
2000.
TheQualityManagementPrinciples(ascontainedinISO9000:
2000)shallbeapplied,unchanged,forthisamendment.
4.Compatibility
Therearetwomainareaswherecompatibilityissuesshallbeaddressed:
4.1ISO14001
TheconceptofcompatibilitydevelopedjointlybyISO/TC176/SC2andISO/TC207/SC1shallbeusedinthisproject.Thisdefinitionisasfollows:
InthecaseofaManagementSystemStandard,“compatibility”shallmeanthatcommonelementsofthestandardscanbeimplementedbyorganizationsinasharedmanner,inwholeorinpart,withoutunnecessaryduplicationortheimpositionofconflictingrequirements.“Compatibility”shallnotmeanthatthetextofthecommonelementsofthestandardsneedstobeidentical,althoughitshouldbewheneverthisispossibleinpractice.
NotingthatISO14001:
2004hasbeenpublishedandishighlycompatiblewithISO9001:
2000,theproposedamendmenttoISO9001:
2000shallmaintainthecurrentlevelofcompatibilityandstrivetoenhancethiscompatibility.
ItisimportanttonotewhenmaintainingcompatibilitywithISO14001:
2004thatthefollowingdonotnecessarilyrepresentpotentialconflicts:
∙Differenttextincommonelementsorterminology
∙Differentnumberingoftheclauses
∙Differentmodelsandstructure
∙Inclusionofguidance,notesorannexes
4.2Sectorspecificandotherstandards
AnumberofothermanagementsystemstandardsarebasedonISO9001:
2000andhaveuseditsstructureandtext.ThewritersoftheamendmentneedtobeawareoftheimpactofchangesonthecompatibilityofothermanagementsystemstandardstoISO9001.
5.Consistency
ConsistencybetweentheamendmentofISO9001:
2000andtherevisionofISO9004:
2000means:
∙lackofconflictbetweenthestandards,
∙thestandardscomplementeachother,butareabletostandalone,
∙harmonizedconceptsandterminology,
∙easytransitionfromonestandardtotheother,
∙thetwostandardscanbereadilyappliedwithinthesamequalitymanagementsystem.
Inthe2000versionsofISO9001andISO9004,thestructuralconsistencybetweenthestandardswasemphasizedbyaligningsimilarclausestothegreatestextentpossible.Inthenexteditionsofthestandards,thisrigidalignmentoftheclauseswillberelaxedsothatISO9004hasmoreflexibilitytomeettheneedsofitsusers.
ConsistencywithotherstandardsoftheISO9000familyshallalsobemaintained.
6.Modelanditsfeatures
TheprocessmodelasshowninISO9001:
2000,Figure1,shallremainunchanged.
7.Structureofthestandard
TominimizetheimpactonusersandtomaintainorenhancethecompatibilityofISO9001withothermanagementsystemstandardsandrelevantdocuments,theoverallstructureofthestandardshallremainunchanged.
Somemovementofrequirementswithinorbetweenclausesmaybeallowediftheintentofthestandardisnotchanged,theimpactonusersislimitedandthemovementcontributestoclearerunderstandingforusersofthestandard.Thedraftersoftheamendmentshallconsiderthelimitationsdefinedinclause1.2Applicationwhenmovingrequirements.
8.Subjectstobeaddressedinthetextoftheamendedstandard
AnanalysiswasmadeofthedocumentslistedinAnnexA,toidentifytheclausesinISO9001:
2000thatmaybesubjectedtoamendment.Theta
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