臺灣博碩士論文加值系統

ISO 9001：2015 標準之內容與架構與ISO 9001：2008 標準差異性大，藉此
國際標準組織認為有必要出版ISO/TS 9002：2016「品質管理系統-ISO 9001：2015應用之指導綱要」，進行額外的指導，使管理者能快速適應版本的變化。
ISO 於2012 年時提出了「附錄SL」，其中提出了一套全新的高階結構、
通用形式與術語，並且應用在ISO 9001：2015 標準上，希望將各標準間實
施時的衝突及矛盾消除並整合。許多標準也將依照此架構進行改版，為符
合條文中此架構之要求，進行多次修改，此變動幅度與影響程度可說是史
無前例。
有鑑於此，本研究針對ISO 公佈之ISO/TS 9002：2016「品質管理系
統-ISO 9001：2015 標準應用之指導綱要」標準條文內容分析與說明，將
ISO 9001：2015 標準(CNS12680：2016)所規定之相關要求，進行更詳細之
說明並列舉實例，並繪製過程關聯圖、內容架構圖與相關圖表，期盼使用
者能快速地瞭解ISO 9001：2015 標準之重點項目，且快速上手運用得當。

The contents and structure of ISO 9001：2015 are big different from ISO 9001：
2008, therefore International Organization for Standardization considers it necessary
to publish ISO/TS 9002：2016“Quality management systems-Guidelines for the
application of ISO 9001：2015”for additional guidance.It makes managers quickly
adapt to changes in the version.
At 2012, ISO published “Annex SL”, which had a brand new high level structure,
common form and terminology inside.It applied on the ISO 9001：2015 and hoped can
eliminate the conflict, contradiction and integration when operated different standards.
Lots of standards will revise according to Annex SL, and in order to keep up to the
trends, requirements in the clauses also have done lots of modifications. Both of the
range of variation and degree of influence were unprecedented.
In view of this, this study is aimed to discusses and explains ISO/TS 9002：2016
【Quality management systems-Guidelines for the application of ISO 9001：2015】.It
take related requirements of ISO 9001：2015(CNS12681) which provide more
detailed description and examples. Draw associate ed diagram of process, structure of
detail and related graphics help users can quikly understand key point of ISO 9001：
2015 and using properly.

中文摘要............................... I
ABSTRAC............................... II
誌 謝................................. III
圖目錄................................ VIII
表目錄................................ IX
緒論................................... 1
1.1 研究動機............................ 1
1.2 研究目的............................ 2
1.3 研究對象及範圍....................... 2
1.4 研究方法與流程....................... 2
文獻回顧................................ 4
2.1 ISO 9000 標準簡介................... 4
2.1.1 ISO 9000：2005 與ISO 9000：2015
【Quality management systems-Fundamental and Vocabulary】標準
(CNS12680：2008 與CNS12680：2016) ........................................ 4
2.2 ISO 9001 標準簡介 ................... 8
2.2.1 Annex SL架構之簡介................. 8
2.2.2 ISO 9001：2008 標準【Quality management systems –
Requirements】(CNS12681：2009) ....................................... 10
2.2.3 ISO 9001：2015 標準【Quality management systems –
Requirements】 ........................ 11
2.3 ISO/TS 9002：2016 標準簡介 ......... 14
2.3.1 ISO/TS 9002：2016 背景介紹 ....... 14
ISO/TS 9002：2016 標準之條文說明 ........ 15
3.1 適用範圍............................ 15
3.2 引用標準............................ 15
3.3 名詞與定義........................... 16
3.4 組織環境............................ 17
3.4.1 瞭解組織與其組織之環境.............. 17
3.4.2 瞭解利害相關者之需求................ 21
3.4.3 確定品質管理系統之範疇............... 26
3.4.4 品質管理系統與其過程................. 28
3.5 領導................................. 34
3.5.1 領導與承諾.......................... 34
3.5.2 政策............................... 40
3.5.3 組織之角色、職責與權限............... 43
3.6 規劃................................. 45
3.6.1 處理風險與機會之措施................. 45
3.6.2 品質目標與實現目標之規劃.............. 48
3.6.3 變更之規劃........................... 51
3.7 支援.................................. 53
3.7.1 資源................................ 53
3.7.2 智能................................ 63
3.7.3 認知................................ 65
3.7.4 溝通................................ 67
3.7.5 文件化資訊........................... 69
3.8 運作.................................. 74
3.8.1 運作規劃與管制........................ 74
3.8.2 產品與服務要求之確定................... 76
3.8.3 產品與服務之設計與開發................. 83
3.8.4 由外部提供之產品與服務之管制............ 95
3.8.5 生產與服務之提供...................... 101
3.8.6產品與服務之放行....................... 111
3.8.7 不符合之過程輸出、產品與服務之管制...... 112
3.9 績效評估................................ 116
3.9.1 監測、量測、分析與評估................. 116
3.9.2 內部稽核.............................. 122
3.9.3 管理審查.............................. 127
3.10 改進................................... 132
3.10.1 概要................................. 132
3.10.2 不符合與矯正措施...................... 134
3.10.3 持續改進............................. 137
結論與建議.................................. 139
4.1 結論.................................... 139
4.2 建議.................................... 141
參考文獻..................................... 143

[1] ISO 9000, “Quality management systems - Fundamentals and vocabulary”,
International Organization for Standardization,USA (2005).
[2] ISO 9000, “Quality management systems - Fundamentals and vocabulary”,
International Organization for Standardization,USA (2015).
[3] ISO 9001, “Quality management systems - Requirements”, International
Organization for Standardization,USA (2008).
[4] ISO 9001, “Quality management systems - Requirements”, International
Organization for Standardization,USA (2015).
[5] ISO 10001, “Quality management－Customer satisfaction－Guidelines
for codes of conduct for organizations”,International Organization for
Standardization,USA (2007).
[6] ISO 10002, “Quality management－Customer satisfaction－Guidelines
for complaints handling in organizations”,International Organization for
Standardization,USA (2014).
[7] ISO 10003, “Quality management－Customer satisfaction－Guidelines
for dispute resolution external to organizations”,International Organization
for Standardization,USA (2007).
[8] ISO 10004, “Quality management－Customer satisfaction －Guidelines
for monitoring and measuring”,International Organization for
Standardization,USA (2012).
[9] ISO 10005, “Quality management systems－Guidelines for quality
plans”,International Organization for Standardization,USA (2005).
[10] ISO 10006, “Quality management systems－Guidelines for quality
144
management in projects”,International Organization for
Standardization,USA (2003).
[11] ISO 10007, “Quality management systems－Guidelines for configuration
management”,International Organization for Standardization,USA (2003).
[12] ISO 10008, “Quality management－Customer satisfaction－Guidelines
for business-to-consumer electronic commerce transactions”,International
Organization for Standardization,USA (2013).
[13] ISO 10012, “Measurement management systems－Requirements for
measurement processes and measuring equipment”,International
Organization for Standardization,USA (2003).
[14] ISO/TR 10013, “Guidelines for quality management system
documentation”,International Organization for Standardization,USA
(2001).
[15] ISO 10014, “Quality management－Guidelines for realizing financial and
economic benefits”,International Organization for Standardization,USA
(2006).
[16] ISO 10015, “Quality management－Guidelines for training”,International
Organization for Standardization,USA (1999).
[17] ISO 10018, “Quality management－Guidelines on people involvement
and competence”,International Organization for Standardization,USA
(2012).
[18] ISO 10019, “Guidelines for the selection of quality management system
consultants and use of their services”,International Organization for
Standardization,USA (2005).
[19] ISO 19011, “Guidelines for audit management systems”,International
145
Organization for Standardization,USA (2011).
[20] Stephen P. Robbins, Mary Coulter, “Management – twelfth
edition”,PEARSON,USA (2014).
[21] International Register of Certificated Auditors(IRCA), “IRCA briefing
note - Annex SL”,UK (2014).
[22] ISO/IEC Directives, Part 1 Consolidated ISO Supplement — Procedures specific
to ISO(2015).
[23] CNS12680，「品質管理系統-基本原理與詞彙」，經濟部標準檢驗局，
臺灣 (2008)。
[24] CNS12680，「品質管理系統-基本原理與詞彙」，經濟部標準檢驗局，
臺灣 (2016)。
[25] CNS12681，「品質管理系統-要求」，經濟部標準檢驗局，臺灣 (2009)。
[26] CNS12681，「品質管理系統-要求」，經濟部標準檢驗局，臺灣 (2016)。
[27] 林郁軒，「ISO/DIS 9001：2014 標準條文初探之研究」，碩士論文，臺
灣科技大學營建研究所，臺北 (2015)。
[28] 林耀煌；林昱安，「ISO 9000 品質管理系統詞彙」，長松文化興業股份
有限公司，臺北(2016)。
[29] 來新陽；「ISO 9001：2015 與ISO 9001：2008 之差異及其改版重點」，
IECQ 報導年刊，29-34 頁(2015)。
[30] BSI 英國標準協會，「採用Annex SL 未來所有管理系統標準的新高階
架構」，臺灣 (2015)。
[31] 國際標準組織，http://www.iso.org。
[32] 經濟部標準檢驗局，http://www.bsmi.gov.tw。