【正文】 s Managing for sustainable success – a quality management approach Significant change End of 2023 55 ? T220。 ? 內(nèi)部稽核員不必重新取得證照，但仍要求內(nèi)部稽核員熟悉新舊版標(biāo)準(zhǔn)的變更內(nèi)容。 d) 當(dāng)不符合產(chǎn)品在交貨或開始使用後才被發(fā)現(xiàn)， 組織應(yīng)對不符合所導(dǎo)致之影響，或潛在之影響， 採行適當(dāng)之措施。 符合允收準(zhǔn)則之證據(jù)應(yīng)予以維持。 49 ? T220。V Nord: a partner you can count on. 內(nèi)部稽核 應(yīng)建立文件化程序以界定稽核規(guī)劃與執(zhí)行、稽核的紀(jì)錄與結(jié)果呈報之職責(zé)與要求。 此應(yīng)包括可適用方法， 含統(tǒng)計技術(shù)與其使用程度之決定。V Nord: a partner you can count on. 監(jiān)督及量測 裝置 equipment之管制 此外， 當(dāng)設(shè)備被發(fā)現(xiàn)不符合要求時， 組織應(yīng)評鑑與記錄先前量測結(jié)果之有效性。 適用時 (As applicable), 此防護(hù)應(yīng)包括識別、運搬、包裝、儲存及保護(hù) 以維持要求的符合性 (in order to maintain conformity to requirements)。 備考： 在某些產(chǎn)業(yè)領(lǐng)域， 型態(tài)管理是維持識別與追溯性之一種方法。 備註 : 對生產(chǎn)及服務(wù)供應(yīng)提供的資訊包括產(chǎn)品保存的詳細(xì)說明。V Nord: a partner you can count on. 設(shè)計及開發(fā) 設(shè)計及開發(fā)規(guī)劃 組織應(yīng)規(guī)劃並管制產(chǎn)品之設(shè)計與開發(fā)。V Nord: a partner you can count on. 7 產(chǎn)品實現(xiàn) 產(chǎn)品實現(xiàn)之規(guī)劃 組織應(yīng)規(guī)劃與開發(fā)產(chǎn)品實現(xiàn)所需之過程。V Nord: a partner you can count on. 基礎(chǔ)架構(gòu) 組織應(yīng)決定、提供及維持為達(dá)成符合產(chǎn)品要求所需之基礎(chǔ)設(shè)施。 30 ? T220。 (A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.) 28 ? T220。 NOTE 2 An outsourced process is identified as one being needed for the anization’ s quality management system but chosen to be performed by a party external to the anization. Impact 26 ? T220。V Nord: a partner you can count on. 4 品質(zhì)管理系統(tǒng) 一般要求 組織應(yīng)依照本標(biāo)準(zhǔn)之要求， 建立、文件化、實施及維持一品質(zhì)管理系統(tǒng)， 並持續(xù)改進(jìn)其有效性。 ISO 與 IEC 之會員維持最新有效標(biāo)準(zhǔn)之登錄。 備註 1：在本標(biāo)準(zhǔn)內(nèi)，?產(chǎn)品?一詞僅適用於顧客 或產(chǎn)品實現(xiàn)過程 所期望，或所要求之產(chǎn)品 。V Nord: a partner you can count on. ISO9001修訂之主要輸入來源 ? ISO/TC 176 官方解釋 ? ISO 9001:2023 支援文件 ? 歷次的正式審查結(jié)果 ? 使用者意見調(diào)查 ? ISO14001:2023 ? ISO Guide 72:2023 管理系統(tǒng)標(biāo)準(zhǔn)修訂及開發(fā)指導(dǎo)綱要 17 ? T220。V Nord: a partner you can count on. 00 Registration 20 Start of main action 60 Completion of main action 92 Repeat an earlier phase 93 Repeat current phase 98 Abandon 99 Proceed 00 Preliminary stage Approval proposal 10 Proposal stage New project approved 20 Preparatory stage WD approved as CD 30 Committee stage CD approved as DIS 40 Enquiry stage DIS approved as FDIS 50 Approval stage FDIS approved as IS 60 Publication stage IS published 90 Review stage 95 Withdrawal stage ISO9001目前的狀態(tài) 11 ? T220。V Nord: a partner you can count on. ISO 17021 發(fā)展歷程 ISO Guide 62 General Requirements for Bodies Operating Assessment and Certification/registration of Quality Systems ISO Guide 66 General requirements for bodies operating assessment and certification/registration of environmental management systems (EMS) ISO 17021:2023 Conformity assessment Requirements for bodies providing audit and certification of management systems (管理系統(tǒng)驗證機(jī)構(gòu)認(rèn)證規(guī)範(fàn) ) 6 ? T220。V Nord: a partner you can count on. ISO大事紀(jì) (2023 至 2023) 2023 ISO 9000:2023 系列標(biāo)準(zhǔn) 2023 2023 2023 2023 ISO 19011 ISO 17021 ISO 9000 ISO 9001 TS 16949:2023 ISO 14001:2023 ISO 27001:2023 ISO 20230:2023 OHSAS 18001:2023 3 ? T220。 – 驗證機(jī)構(gòu)應(yīng)於證書到期前，執(zhí)行換證稽核並考慮實施不符合事項之矯正措施的期限。V Nord: a partner you can count on. 衝擊的分類準(zhǔn)則 衝擊分類 準(zhǔn)則 High ? Additional or reduced requirements significantly affecting many users ? Change in intent of requirement ? Need for urgent revision of related QMS standards ? Need for extensive changes of an anization’s documentation ? Decreased patibility with ISO 14001 ? Inconsistency within the ISO 9000 family ? Need for recertification or significant transition period ? Need for extensive user education or training Medium ? Minor additional or reduced requirements for some users ? Possible impact on understanding by many users ? Need for limited changes of an anizations QMS documentation ? Need for eventual revision of other QMS standards ? No significant need for additional education or training for users ? Creates a minimal requirement for recertification or transition period Low ? No increased or reduced requirement ? No change in intent of requirement ? No impact on most users ? No need for additional educ