Design Specification for an Amendment to ISO 9001.docx

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