ISO9001-XXXX改版讲义

ISO9001改版研討會(2008)TÜVNord:apartneryoucancounton.2議程大綱•ISO9000大事紀(2000~2008)•ISO19011發展歷程與影響•ISO17021發展歷程與影響•ISO9001發展歷程•ISO9001:2008改版說明與衝擊分析TÜVNord:apartneryoucancounton.3ISO大事紀(2000至2008)2000ISO9000:2000系列標準2002200620052008ISO19011ISO17021ISO9000ISO9001TS16949:2002ISO14001:2004ISO27001:2005ISO20000:2005OHSAS18001:2007TÜVNord:apartneryoucancounton.4ISO19011發展歷程與影響•對貴公司的影響–衝擊(impact)•無–利益(benefit)•可提升內稽人員的稽核技巧ISO10011-1:1990,ISO10011-2:1991,ISO10011-3:1991ISO14010:1996,ISO14011:1996,ISO14012:1996ISO19011:2002Guidelinesforqualityand/orenvironmentalmanagementsystemsauditingTÜVNord:apartneryoucancounton.5ISO19011條文大綱1Scope2Normativereferences3Termsanddefinitions4Principlesofauditing5Managinganauditprogramme6Auditactivities–Initiatingtheaudit–Conductingdocumentreview–Preparingfortheon-siteauditactivities–Conductingon-siteauditactivities–Preparing,approvinganddistributingtheauditreport–Completingtheaudit–Conductingauditfollow-up7CompetenceandevaluationofauditorsTÜVNord:apartneryoucancounton.6ISO17021發展歷程ISOGuide62GeneralRequirementsforBodiesOperatingAssessmentandCertification/registrationofQualitySystemsISOGuide66Generalrequirementsforbodiesoperatingassessmentandcertification/registrationofenvironmentalmanagementsystems(EMS)ISO17021:2006Conformityassessment--Requirementsforbodiesprovidingauditandcertificationofmanagementsystems(管理系統驗證機構認證規範)TÜVNord:apartneryoucancounton.7ISO17021的影響•ISO17021對貴公司的衝擊(impact)–兩階段稽核(twostageaudit)•第一階段(stageoneaudit)–稽核管理系統文件–評估客戶之地點與特定現場狀況–審查客戶對標準的準備狀況，例如：績效、過程、目標等項目的鑑別–收集相關法令與法規事項與遵守情形–審查第二階段稽核資源之配置與商定稽核細節–評估客戶是否已為第二階段稽核做好準備–建議部份第一階段稽核是在客戶現場執行•第二階段(stagetwoaudit)–現場稽核–年審(surveillance)與換證(repeataudit)稽核時間TÜVNord:apartneryoucancounton.8ISO17021的影響兩階段稽核(twostageaudit)•此規定對已經取得證書的客戶沒有影響•第一階段稽核(stageoneaudit)是否在客戶現場執行將依據下列評估準則：ClassificationEvaluationcriteriaABSizeofcompany(規模大小)smallbigCompanystructure(架構)singlemultisiteComplexity(複雜度)(productrange,materials,manufacturingprocesses,organisationstructure)simplecomplexProductrisks(產品風險)lowhighTÜVNord:apartneryoucancounton.9ISO17021的影響年審與換證稽核時間•此規定適用於所有客戶（不論新舊客戶）•年審(surveillance)稽核時間–初次驗證後之第一次年審稽核日期，不得逾越第二階段稽核(stagetwoaudit)最後一天起12個月。•換證(repeataudit)稽核時間–當管理系統或客戶有重大變更時，可能需要有第一階段稽核(stageoneaudit)。–驗證機構應於證書到期前，執行換證稽核並考慮實施不符合事項之矯正措施的期限。2008/09/01矯正措施結案換證稽核發證日期證書到期(三年)初次驗證最後一天2008/11/012011/11/01矯正措施結案Impact年審稽核TÜVNord:apartneryoucancounton.10ISO9001發展歷程ISO9001ISO9002ISO9003ISO9001ISO9002ISO9003ISO9001ISO90011987199420002008YearMinorChangeMajorChange品質原則、過程導向監督量測、詞彙解釋MinorChangeTÜVNord:apartneryoucancounton.11ISO標準修訂流程目前的狀態TÜVNord:apartneryoucancounton.12ISO9001此次改版的目標•改進現有標準•使條文更清晰(clarity)與更容易使用•提升與ISO14001的相容性(一致性)TÜVNord:apartneryoucancounton.13衝擊與利益(impactsandbenefits)•本次修訂(ISO9001:2008)著重於高利益(highbenefit)與低衝擊(lowimpact)的部份。•對於高利益(highbenefit)與高衝擊(highimpact)的部份，將保留到2012年實施。TÜVNord:apartneryoucancounton.14衝擊的分類準則衝擊分類準則High•Additionalorreducedrequirementssignificantlyaffectingmanyusers•Changeinintentofrequirement•NeedforurgentrevisionofrelatedQMSstandards•Needforextensivechangesofanorganization’sdocumentation•DecreasedcompatibilitywithISO14001•InconsistencywithintheISO9000family•Needforrecertificationorsignificanttransitionperiod•NeedforextensiveusereducationortrainingMedium•Minoradditionalorreducedrequirementsforsomeusers•Possibleimpactonunderstandingbymanyusers•NeedforlimitedchangesofanorganizationsQMSdocumentation•NeedforeventualrevisionofotherQMSstandards•Nosignificantneedforadditionaleducationortrainingforusers•CreatesaminimalrequirementforrecertificationortransitionperiodLow•Noincreasedorreducedrequirement•Nochangeinintentofrequirement•Noimpactonmostusers•Noneedforadditionaleducationortrainingforusers•Onlyneedforminimalormarginalchangesofanorganization’sdocumentationTÜVNord:apartneryoucancounton.15利益的分類準則利益分類準則High•Addressesawidelyexpressedspecificuserneedbyimprovingclarityandeliminatingconfusion•Correctsanerrorintheexistingstandard•EliminatesinconsistencieswithinISO9001•EliminatesinconsistencieswithintheISO9000family•EliminatesmajorproblemsoftranslationMedium•Improvesclarityinregardtoawidelyexpresseduserneedbutmaynoteliminateconfusionand/ortranslationdifficulty•Improvesclarityinresponsetoneedsidentifiedbysomeusers•IncreasescompatibilitywithISO14001•Demonstrateswillingnesstorespondtothewishtoseeimprovementincompatibilitybe