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ISO 9001: 2015 新版發展趨勢
Quality Management System ISO 9001:2015
Committee Draft
(委員會草案版 )
2 © SGS SA 2013 ALL RIGHTS RESERVED
Agenda of ISO 9001: 2015 CD
ISO 9001 改版背景
ISO管理系統標準因應Annex SL 改變
品質管理原則變更說明
ISO 9001: 2015 CD 主要變更說明
ISO新版因應建議
ISO 9001 改版背景
4 © SGS SA 2013 ALL RIGHTS RESERVED
Vision of ISO 9001 : 2015
『提供一個可供應未來25年或更長遠未來所使用
之穩定的核心管理要求』 TC176 /SC2主席Nigel H. Croft
5 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 9001:2015 Timeline
2013 2014 2015
3rd June 2013
(Committee Draft)
Q2 2014 DIS
(Draft International Standard)
Q1 2015 FDIS
(Final Draft International Standard)
Q4 2015 PIS (正式版出版 )
Published International Standard
6 © SGS SA 2013 ALL RIGHTS RESERVED
ISO9001:2015 Certification
Transition Timeline
2015 2016 2017 2018
Q4 2015 Published International Standard
Normally after PIS (正式版公告) give 3 years as transition period ( estimated up to Q4 2018 )
ISO管理系統因應ANNEX SL 改變
8 © SGS SA 2013 ALL RIGHTS RESERVED
ISO Directives Annex SL
ISO技術管理局(TMB)委託聯合技術協調小組(JTCG)開發,適用於所有管理系統高階結構標準,與相同核心文本。
最初被稱為指南草案83 ( Draft Guide 83 ),在2012年4月,它被修訂的ISO指令( ISO Directives) 作為附件SL(Annex SL )出版。
ISO Directives Annex SL 高階管理架構
9 © SGS SA 2013 ALL RIGHTS RESERVED
Discipline Specific Standard
(ISO 9001)
Discipline Specific
Standard (ISO 14001)
Discipline Specific
Standard (ISO 22000)
Annex SL 描述了一個通用的管理系統的架構。然而,在架構增加各管理特定的要求,即將使成為滿足各管理系統標準,如品質,環境,食品安全,資訊安全和能源管理系統。
ISO Directive ANNEX SL 對ISO管理系統標準 的結構與內容有重大衝擊
Annex SL
10 © SGS SA 2013 ALL RIGHTS RESERVED
ISO Annex SL 10項章節標題
1. 範圍 (Scope)
2. 引用標準 (Normative references)
3. 用語與定義 (Terms and Definitions)
4. 組織環境 (Context of Organization)
5. 領導 (Leadership)
6. 規劃 (Planning)
7. 支援 (Support)
8. 營運 (Operation)
9. 績效評估 (Performance Evaluation)
10. 改善 (Improvement)
ISO DIRECTIVE ANNEX SL
11 © SGS SA 2013 ALL RIGHTS RESERVED
Key Value adding activities Information flow
Figure 1 - Illustration of a process-based quality management system
ISO 9001 : 2008 REQUIREMENTS
12 © SGS SA 2013 ALL RIGHTS RESERVED
ISO Annex SL 高階管理架構 (ISO 27001: 2013 架構圖 )
§ 4
§ 6
§ 7
§ 5
§10
§ 9
Documented Information
§ 8
Context & Interested Parties
Context & Interested Parties
Information Security Management requirements and expectations
Information Security managed
13 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 14001:2015 CD 系統架構
14 © SGS SA 2013 ALL RIGHTS RESERVED
Key Value adding activities Information flow
Figure 1 - Illustration of a process-based quality management system
ISO 9001 : 2015 系統架構尚未公佈
15 © SGS SA 2013 ALL RIGHTS RESERVED
經濟成長
(生產)
社會責任
(生活)
環境整體
(生態)
15
能源
永續發展
ISO 27001
ISO 20000
ISO 28001
ISO 9001
ISO 22000
ISO 50001
ISO 14001
ISO 14004
ISO 14040
ISO 14064
ISO 20121
ISO/TS 14067 ISO 39001
ISO 22301
ISO 26000
SA 8000
OHSAS 18001
ISO/TS 16949
資安 供應鏈
IT服務
汽車
環境(要求)
生命週期
環境(指南)
溫室氣體
碳足跡
事件永續
道路安全
營運持續
社會責任指南
社會責任要求
食安
職安衛
品質
ISO 管理系統整合應用發展趨勢- 永續成功經營強調經濟趨勢、環境還整性及社會責任
16 © SGS SA 2013 ALL RIGHTS RESERVED
未來幾年將是ISO標準大改版期 ( SIGNIFICANT IMPACT OF ISO ANNEX SL )
改版標準
ISO 9001:2008 => ISO 9001:2015
ISO 14001:2004 => ISO 14001:2015
ISO/IEC 27001:2005 => ISO/IEC 27001:2013
OHSAS 18001:2007 => ISO 45001:2016
BS 25999 => ISO 22301: 2013
ISO 22000:2005 => ISO 22000:201x
TL 9000
AS 9100
ISO 13485
ISO/TS 16949
新標準
ISO 55001:2014 (Asset management system)
ISO 39001 : 2013 ( In land transportation safety MS )
ISO 20121: 2012 ( Event Sustainability MS )
品質管理原則變更說明
18 © SGS SA 2013 ALL RIGHTS RESERVED
QM Principle Change
ISO 9001:2008 ISO 9001:2015
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to
management
6. Continual improvement
7. Factual approach to
decision making
8. Mutually beneficial
supplier relationships
1. Customer Focus
2. Leadership
3. Engagement of
People
4. Process Approach
5. Improvement
6. Evidence-based
Decision Making
7. Relationship
Management
19 © SGS SA 2013 ALL RIGHTS RESERVED
領導力
( clause 5 )
人員結合
( 5.1.1 h )
流程方法
( 4.4.2 )
關係管理
( 8.2.1, 8.4 )
改善
( Clause 10 )
證據為依據之決策
( 9.1 )
客戶導向
( 5.1.2 )
品質管理原則要求積極寫進 ISO 9001: 2015 CD
ISO 9001: 2015 CD 主要變更說明
21 © SGS SA 2013 ALL RIGHTS RESERVED
Structure Change
( 根據 Annex SL ) ISO9001:2008 ISO9001:2015
1. Scope
2. Normative references
3. Terms and definitions
4. Quality management
system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and
improvement
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. improvement
22 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 9001: 2015 CD 結合相關經營管理
策略規劃
風險管理
流程管理
知識管理
溝通管理
供應鏈及分包商管理
職能管理
績效管理
願景領導
客戶關係與需求管理
持續改善與變革
…
23 © SGS SA 2013 ALL RIGHTS RESERVED
CD version Major Changes (1)
Top management engagement 強化高階投入
- 第 4 章 組織環境
- 第 5 章 領導
- 第 6 章 規劃
- 第 9 章 績效評估
Context of Organization 組織環境
- 4.1 瞭解組織環境
- 4.2 瞭解利益相關者的需求與期望
Process Approach 流程方法 ( 4.4.2 )
24 © SGS SA 2013 ALL RIGHTS RESERVED
CD version Major Changes (2 )
Leadership & Commitment 領導與客戶承諾
- 5.1.1 品質系統的領導與承諾
- 5.1.2 顧客需求與期待的領導與承諾
Risks and Opportunities 風險與機會 ( 6.1 )
Document control 文件管制與記錄彈性化
- 7.5 書面資訊
Outsource management 外包管理大幅強化
- 8.4.1 外部提供的物品與服務 通則
- 8.4.2 外部供應商 管制的範圍與類型
- 8.4.3 外部供應商的書面資訊
- 8.5.3 開發轉移
25 © SGS SA 2013 ALL RIGHTS RESERVED
CD VERSION OTHER CHANGES
4.3 Exclusion ( 排除條款)
排除應限於7.1.4 量測校正與第 8 章營運作業
外包安排不足以作為排除的理由依據
變更/變革管理的強化
6.3 變更的規劃
8.6.6 變更的管制
強調 7.2 能力(competence) 與 7.3認知 ( awareness )
強調 軟性管理能力:7.4內外部溝通 與 7.1.3人性化的工作環境
新要求:知識管理 (7.1.5 )
新要求 : 開發轉移 ( 8.5.3 )
26 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 9001:2008 ISO 9001:2015 CD
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
4. Quality Management System 4. Context of the organization
4.1 General Requirements 4.1 Understanding the organization and its
context
4.2 Documentation Requirements 4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system
5. Management Responsibility 5.Leadership
5.1 Management Commitment 5.1 Leadership and commitment
5.2 Customer Focus 5.2 Quality Policy
5.3 Quality Policy 5.3 Organizational roles, responsibilities and authorities
5.4 Planning 6. Planning
5.5 Responsibility, Authority, and Communication
6.1 Actions to address risks and opportunities
5.6 Management Review 6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
ISO 9001: 2008 與 2015 CD對照表
27 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 9001:2008 ISO 9001:2015 CD
6. Resource Management 7. Support
6.1 Provision of Resources 7.1 Resources
6.2 Human Resources 7.2 Competence
6.3 Infrastructure 7.3 Awareness
6.4 Work Environment 7.4 Communication
7.5 Documented information
7.1 Planning of Product Realization 8. Operation
7.2 Customer-Related Processes 8.1 Operational planning and control
7.3 Design and Development 8.2 Determination of market needs and interactions with
customers
7.4 Purchasing 8.3 Operational planning process
7.5 Production and Service Provision 8.4 Control of external provision of goods and services
7.6 Control of Monitoring and Measuring
Equipment
8.5 Development of goods and services
8.6 Production of goods and provision of services
8.7 Release of goods and services
8.8 Nonconforming goods and services
ISO 9001: 2008 與 2015 CD對照表
28 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 9001:2008 ISO 9001:2015 CD
8. Measurement, Analysis, and Improvement 9. Performance evaluation
8.1 General 9.1 Monitoring, measurement, analysis and evaluation
8.2 Monitoring and Measurement 9.2 Internal Audit
8.3 Control of Nonconforming Product 9.3 Management review
8.4 Analysis of Data 10. improvement
8.5 Improvement 10.1 Nonconformity and corrective action
10.2 Improvement
ISO 9001: 2008 與 2015 CD對照表
ISO新版因應建議
30 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 9001 : 2015 最大利益
ISO 9001: 2015 CD
是中小企業邁向卓越績效經營的最佳系統選擇
『提供一個可供應未來25年或更長遠未來所使用
之穩定的核心管理要求』 TC176 /SC2主席Nigel H. Croft
31 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 9001 : 2015 最大利益
經營管理與品質管理重點結合
強調品質經營績效管理
強化經營規劃:風險評估與經營環境變遷納入系統管理
要求高階經營者領導,投入,承諾與執行力
運用整合系統打造組織各自核心經營體系
Manager & staff 認知與職能搭配提昇是新版成功基礎
32 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 新版台灣企業因應之道
留意SGS國際驗證電子報:改版最新訊息
一旦改版標準與轉版訊息確定,SGS 將提供一系列協助,支援與諮詢服務,幫助客戶順利渡過版本轉換
建議中大型企業 : 提前準備與導入享受新版利益
新增經營管理要求大部分已具備
參酌部分ISO 9004 good practice
強化風險管控,提昇經營積效
落實新版是邁向上市櫃公司管理系統基礎
建議小企業 : 等待新版優良改版模式建立後再行動
33 © SGS SA 2013 ALL RIGHTS RESERVED
ISO 9001: 2015 驗證方式趨勢
Risk approach audit ( 風險導向稽核)
Performance Approach audit ( 績效導向稽核)
Integration audit ( 整合導向稽核)
Auditor awareness and competence : 驗證機構的挑戰
34 © SGS SA 2013 ALL RIGHTS RESERVED
Further Excellence 您永續成功的信頼夥伴