【正文】 Nord: a partner you can count on. 衝擊與利益 (impacts and benefits) ? 本次修訂 (ISO 9001:2023)著重於 高利益 (high benefit) 與低衝擊 (low impact)的部份。 ? 對於 高利益 (high benefit) 與 高衝擊 (high impact)的部份，將保留到 2023年實施。 13 ? T220。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 education or training for users ? Only need for minimal or marginal changes of an anization’s documentation 14 ? T220。V Nord: a partner you can count on. 利益的分類準(zhǔn)則 利益分類 準(zhǔn)則 High ? Addresses a widely expressed specific user need by improving clarity and eliminating confusion ? Corrects an error in the existing standard ? Eliminates inconsistencies within ISO 9001 ? Eliminates inconsistencies within the ISO 9000 family ? Eliminates major problems of translation Medium ? Improves clarity in regard to a widely expressed user need but may not eliminate confusion and/or translation difficulty ? Improves clarity in response to needs identified by some users ? Increases patibility with ISO 14001 ? Demonstrates willingness to respond to the wish to see improvement in patibility between ISO 9001 and ISO 14001 even though alignment is not a priority for this amendment ? Reduces problems of translation Low ? Improves clarity only in response to low number of requests for improvement ? Marginal improvement in clarity where benefit may be offset by risk of unintended consequences, . with respect to translation, interpretation ? Changes not addressing a clear user need 15 ? T220。V Nord: a partner you can count on. 衝擊與利益分析 利益 衝擊 High 1 Medium 2 Low 3 Low (1) 1 2 3 Medium (2) 2 4 6 High (3) *3 6 9 12 Incorporate the change. 34 Additional analysis should be conducted prior to making the decision. 69 Do not incorporate the change. Note: ‘*3 high impact x high benefits’ No change allowed. 16 ? T220。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. 使用者意見調(diào)查結(jié)果 ? 63國 941位使用者回覆 ? 1477項意見被提出 ? 涵蓋四大領(lǐng)域 (硬體、軟體、材料加工與服務(wù) ) ? 80%的使用者滿意 ISO9001:2023標(biāo)準(zhǔn) 18 ? T220。V Nord: a partner you can count on. 使用者意見調(diào)查結(jié)果 ISO9001是否符合你的需求 ? 是否喜歡過程導(dǎo)向 ? 19 ? T220。V Nord: a partner you can count on. 差異分析 – 一般說明 (2023 vs. 2023) 項目 ISO9001:2023 與 ISO9001:2023 差異分析 1. 條文架構(gòu) 完全一樣，沒有修改 2. 章節(jié)編號 完全一樣，沒有修改 3. 名詞解釋 定義於 ISO9000:2023中 4. 原理原則 依然沿用八大品質(zhì)管理原則，沒有修改 依然沿用過程導(dǎo)向，沒有修改 5. 條文內(nèi)容 小修改 (minor change) 20 ? T220。V Nord: a partner you can count on. 差異分析 – 一般說明 ? 為了幫助學(xué)員比較 ISO9001新舊版的差異，本次簡報內(nèi)容刻意將 ISO9001:2023的內(nèi)容保留，並以下列方式呈現(xiàn)： – 刪除線 ：表示原 ISO9001:2023的內(nèi)容已被刪除， – 粗體斜體字並加底線 ：表示 ISO9001:2023新增的內(nèi)容。 ? 本簡報未列出的章節(jié)表示 ISO9001新舊版的內(nèi)容一樣。 21 ? T220。V Nord: a partner you can count on. 概述 本標(biāo)準(zhǔn)規(guī)定品質(zhì)管理系統(tǒng)要求， 當(dāng)組織： (a)需要展示其一致地提供符合顧客與適用 法令與 (statutory and) 法規(guī)要求的產(chǎn)品之能力， 及 (b)藉由系統(tǒng)之有效應(yīng)用， 朝向提高顧客滿意度， 包括系統(tǒng)持續(xù)改進(jìn)之過程及符合顧客與適用 法令與 (statutory and) 法規(guī)要求之保證。 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 。這適用於任何產(chǎn)品實現(xiàn)過程的輸出結(jié)果，包括採購。 (or the product realization processes. This applies to any intended output resulting from product realization processes, including purchasing.) 備註 2：法令及法規(guī)的要求可以被視為法律要求。 (NOTE 2 Statutory and regulatory requirements may be expressed as legal requirements.) 22 ? T220。V Nord: a partner you can count on. 2 引用標(biāo)準(zhǔn)