iso9000-2000質(zhì)量體系過程方法指南

1、 第三部分 質(zhì)量管理體系過程方法指南Guidance on the Process Approach to Quality Management Systems Document: ISO/TC 176/SC 2/N544December 2000 ISO 1 前 言新的 ISO 9000:2000 標(biāo)準(zhǔn)提倡組織在建立 貫徹和改進(jìn)其質(zhì)量管理體系 QMS 時采用過程方法 Standards promote the adoption of a process approach when developing, implementing and improving a quality managem

2、ent system (QMS). ISO 9000:2000 標(biāo)準(zhǔn) 2.4 條款 過程方法明確描述過程方法如下任何一個或一組活動 使用一定的資源 將輸入轉(zhuǎn)化為輸出都可視為過程 Any activity, or set ofactivities, that uses resources to transform inputs to outputs can be considered as a process. 要使組織有效運作 管理者必須明確和管理許多相互獨立 相互聯(lián)系又相互作用的過程 通常 一個過程的輸出將是下一個或多個過程的輸入 ISO 9001:2000 版標(biāo)準(zhǔn)所將的 過程方法 是系統(tǒng)地

3、明確和管理這些過程 尤其是相互作用的過程 For organizations to function effectively, they have to identify and manage numerous interrelated and interacting processes. Often, the output from one process will directly form the input into the next process. The systematic identification and management of the processes emplo

4、yed within an organization and particularly the interactions between such processes is referred to as the process approach. 新標(biāo)準(zhǔn)整體結(jié)構(gòu)采用了這一過程方法 替代 94 版標(biāo)準(zhǔn)的 20 個要素 結(jié)構(gòu) This process approach is reflected in the new structure of ISO 9004:2000 (Quality Management Systems Guidelines for performance improvemen

5、t ), and also in ISO 9001:2000 ( Quality management systems Requirements), replacing the 20 element structure of ISO 9001:1994. 質(zhì)量管理八項原則中以下兩項原則為新標(biāo)準(zhǔn)提供了 過程方法 的基礎(chǔ) Two of the eight quality management principles on which the new standards are based relate to the Process approach and the System approach t

6、o management as follows: 過程方法 - 將有關(guān)的資源和活動當(dāng)作一個過程來管理 更加有效地幫助組織達(dá)到預(yù)期的結(jié)果 ProcessApproach: a desired result is achieved more efficiently when activities and related resources are managed as a process. 管理的系統(tǒng)方法 - 在一個既定的目標(biāo)下 明確 理解和管理一個包含相互作用過程的體系 使組織不斷改進(jìn)其效率和效益 System approach to management: identifying, under

7、standing and managing of interrelated processes as a system of for a given objective contributes to the effectiveness and efficiency of the organization. 32ISO9000:2000 質(zhì)量管理體系應(yīng)用指南-第三部分MOODY INTERNATIONAL CERTIFICATION LTD.304, Rainbow Building, Tuanjiehu Beisantiao, Beijing 100026, ChinaTel.: (0) 10

8、8597 8853Fax: (0) 10 85978857E-mail: adminisM 這一指南文件旨在幫助組織理解新標(biāo)準(zhǔn)的理念和 過程方法 的內(nèi)涵 This guidance document is intended to help users of the new ISO 9000:2000 standards to understand the concepts and intent of this process approach to management. 2 過程方法 The Process Approach過程方法旨在達(dá)到一個動態(tài)和持續(xù)改進(jìn)的循環(huán) 使組

9、織在每一次循環(huán)中獲得明顯收益 尤其是在其產(chǎn)品和業(yè)績 有效性 效率和成本方面獲得收益 The process approach aims at achieving a dynamic cycle of continual improvements and allows significant gains to the organization, typically in terms of product and business performance, effectiveness, efficiency and costs. 組織應(yīng)以顧客為中心 通過明確主要過程 及其變化趨勢和改進(jìn) 提高顧客滿

10、意度 從而建立市場競爭優(yōu)勢 ISO 9004:2000 附錄 A 中推薦了組織自我評估的方法 幫助組織確定過程的成熟度 The process approach also facilitates customer focus and increased customer satisfaction through the identification of the key processes within an organization, their subsequent development and continual improvement. Self-assessment methodo

11、logies such as the one proposed in annex A of ISO 9004:2000 may be used to evaluate process maturity levels. 過程方法鼓勵組織對其所有過程建立清楚的認(rèn)識 不僅局限于質(zhì)量管理體系所必要的過程 一個過程包含一個或多個活動 將輸入轉(zhuǎn)化為輸出 輸入和輸出通常是有形的和/或無形的能源 信息和財務(wù)結(jié)果等其它 要使過程有效進(jìn)行 組織必須配備適當(dāng)?shù)馁Y源系來收集與過程有關(guān)的信息和數(shù)據(jù) 分析過程的表現(xiàn)和/或輸入和輸出的特性如設(shè)備 材料 元 件組織可采用某中測量體The process approachenc

12、ourages the organization to develop a clear understanding of all its processes, not only those that are needed for its quality management system. A process consists of one or more activities that transform inputs into outputs. Inputs and outputs are generally products that may be tangible and/or int

13、angible. Examples of inputs and outputs may include equipment, materials, components, energy, information and financial resources, among others. To perform activities within the process appropriate resources have to be allocated. A measurement system can be used to gather information and data to ana

14、lyse process performance and/or input and output characteristics. ISO 9001:2000 標(biāo)準(zhǔn)中管理過程的相互作用及監(jiān)控和測量過程 過程方法要求組織明確 貫徹 管理和持續(xù)改進(jìn)構(gòu)成質(zhì)量管理體系過程的有效性從而達(dá)到組織的質(zhì)量目標(biāo) 這包含了最高管理者 產(chǎn)品實現(xiàn)和相關(guān)支持過程 以Within the context of ISO 9001:2000, the process approach requires anorganization to identify, implement, manage and continually

15、improve the effectiveness of the processes that are necessary for the quality management system, and to manage the interactions of these processes in order to achieve the organizations objectives. This includes top management, product realization and relevant support processes, as well as monitoring

16、 and measurement processes. 過程方法在質(zhì)量管理體系中的應(yīng)用如圖一所示如下 A schematic representation of a process approach implementation for a QMS is described in Figure 1. 33ISO9000:2000 質(zhì)量管理體系應(yīng)用指南-第三部分MOODY INTERNATIONAL CERTIFICATION LTD.304, Rainbow Building, Tuanjiehu Beisantiao, Beijing 100026, ChinaTel.: (0) 10859

17、7 8853Fax: (0) 10 85978857E-mail: adminisM 實現(xiàn)過程圖 1 過程方法 Process Approach 最高管理過程包括策劃 資源分配和管理評審等 Top management process includes for example,planning, allocation of resources and management review, etc. 實現(xiàn)過程包括與顧客有關(guān)的過程 設(shè)計和開發(fā) 產(chǎn)品/服務(wù)實現(xiàn) 采購等過程 Realization process covers for example, customer rela

18、ted process, design & development, produce realization process, purchasing process etc. 支持過程包括培訓(xùn) 保養(yǎng)和維護(hù) 環(huán)境等 Support process includes training, maintenance,environment, etc. 過程的有效性和效率可通過內(nèi)部或外部評審 根據(jù)適當(dāng)?shù)某墒於戎笜?biāo)來判定 成熟度指標(biāo)可根據(jù)組織的類型 行業(yè) 周邊水準(zhǔn) 產(chǎn)品或服務(wù)特性建立相對的指標(biāo) 如 1-5 分制1 代表管理體系還未建立5代表最佳結(jié)果 質(zhì)量/成本這一方法的優(yōu)點在于將過程有效性量化 便于隨時監(jiān)控

19、 從而達(dá)到持續(xù)改進(jìn)的目標(biāo) 過程成熟度的測量有許多方法 以使用于不同的組織和場合 ISO 9004:2000 中介紹了其中一種方法 Process effectiveness and efficiency can be assessed through internal or external review processes and evaluated on a maturity scale. These scales typically range in degrees of maturity from no formal system to best-in-class performanc

20、e. An advantage to this approach is that results can be documented and monitored over time to reach improvement goals. Numerous maturity tables have been developed for different applications. One such model is contained in ISO 9004:2000 annex A, Guideline for Self-Assessment. 3P-D-C-A 循環(huán)和過程方法 P-D-C-

21、A Cycle and the process approachPDCA 是一個動態(tài)循環(huán) 可用于組織的過程 包括產(chǎn)品實現(xiàn)及其它質(zhì)量管理體系過程的策劃 貫徹 控制和持續(xù)改進(jìn) PDCA (Plan-Do-Check-Act) is a dynamic cycle that can be deployed within the 34ISO9000:2000 質(zhì)量管理體系應(yīng)用指南-第三部分支持過程 顧客和法規(guī)要求 顧 客和 社會 公眾 最高管理過程 MOODY INTERNATIONAL CERTIFICATION LTD.304, Rainbow Building, Tuanjiehu Beisan

22、tiao, Beijing 100026, ChinaTel.: (0) 108597 8853Fax: (0) 10 85978857E-mail: adminisM organizations processes. It is intimately associated with the planning, implementation, control and continual improvement of both product realization and other quality management system processes. 在組織各個層次

23、 均可采用 PDCA 理念保持和持續(xù)改進(jìn)過程能力 不僅對高層次管理過程適用如質(zhì)量管理體系策劃和管理評審 對基層運作活動也同樣適用 Maintaining and continually improving the process capability can be achieved by applying the PDCA concept at all levels within the organization. This applies equally to high-level strategic processes, such as quality management system

24、planning, or management review, and to simple operational activities carried out as a part of product realization processes. ISO 9001:2000 標(biāo)準(zhǔn)對 PDCA 循環(huán)在過程中的應(yīng)用做了如下解釋 The Note in Clause 0.2 of ISO 9001:2000explains that the PDCA cycle applies to processes as follows: 策劃Plan 根據(jù)組織顧客要求和 建立目標(biāo)和達(dá)到目標(biāo)必須的過程Esta

25、blish the objectivesand processes necessary to deliver results in accordance with customer requirementsand the organizations policies; 實施 Do貫徹過程 Implement the processes;檢查Check 根據(jù) 目標(biāo)和要求監(jiān)控產(chǎn)品 過程結(jié)果并報告結(jié)果 Monitor and measure processes and prot policies, objectives and requirements forthe product and repo

26、rt theresults;改進(jìn)Act 采 取 措進(jìn) 過acttinually improve process performance;4 相互作用過程的管理 The management of interacting processes 組織各種活動的相互關(guān)系有時非常復(fù)雜 從而構(gòu)成各種過程及分過程的網(wǎng)絡(luò) 這些過程的輸入和輸出與內(nèi)部和外部顧客有關(guān) 圖三舉例說明過程網(wǎng)絡(luò)的相互關(guān)系 管理的 系統(tǒng)方法 使得各個策劃的過程相互協(xié)調(diào)和兼容 并明確各個過程之間的接口關(guān)系 The interdependencies of an organizationsactivities can sometimes be

27、 complex, resulting in a network of various processes and sub-processes. Inputs and outputs of these processes relate to both external and internal customers. An example of a network with interacting processes is shown in Figure 3. The System Approach to management allows for the coordination and co

28、mpatibility of an organizations planned processes and a clear definition of their interfaces. 35ISO9000:2000 質(zhì)量管理體系應(yīng)用指南-第三部分和測量過程D 實施 P 策劃ions to co過程 程 業(yè) 績 TakeC 檢查施 持 續(xù) 改du Act改a進(jìn)gainMOODY INTERNATIONAL CERTIFICATION LTD.304, Rainbow Building, Tuanjiehu Beisantiao, Beijing 100026, ChinaTel.: (0) 1

29、08597 8853Fax: (0) 10 85978857E-mail: adminisM ISO 9001:2000 標(biāo)準(zhǔn)規(guī)定了一系列過程控制的要求 這些要求適用于各類型和不同規(guī)模的組織 組織應(yīng)明確 并將質(zhì)量管理體系必需的過程連接起來 使之成為一個有機(jī)的整體 ISO 9001:2000 specifies a number of requirements for the control of an organizations processes. These requirements are applicable to any type and size of org

30、anization and are typically met by defining and linking those processes that are needed for quality management and integrating them into a system. 在圖三中加入 PDCA 循環(huán) 使管理體系在一個整體框架下運行 表示管理和控制不僅適用于個體過程 同樣也適用于整個網(wǎng)絡(luò) The PDCA cycle has been added to figure 3 to illustrate in a schematic way that management and

31、 control are equally applicable to individual processes and to the network as a whole. 過程網(wǎng)絡(luò)模式表明 顧客在確定過程輸入要求的環(huán)節(jié)中起到了重要作用 顧客對過程輸出的滿意或不滿意的反饋將成為組織質(zhì)量管理體系持續(xù)改進(jìn)的輸入 The model of the network of processes illustrates that customers play a significant role in defining requirements as inputs. Customers feedback o

32、n satisfaction or dissatisfaction ofprocess outputis anessential inputto the continualimprovementprocessoftheQMS.APCDAPAP管 理CDPA輸出過 程 ECD支 持管理過 程C管 理支 持輸出 過 程 F管 理支 持過 程 DAP內(nèi)部顧客CD支 持APCD圖 3- 過程網(wǎng)絡(luò) Figure 3 Network of Processes5結(jié)合ISO 9001:2000 標(biāo)準(zhǔn)要求 貫徹過程方法 Implementation of the Process Approach in rela

33、tionto ISO 9001:2000 RequirementsISO 9001:2000 標(biāo)準(zhǔn) 前言 0.2 條款中要求 Clause 0.2 in the introduction of ISO 9001:2000 states:在質(zhì)量管理體系中 過程方法強(qiáng)調(diào)下列方面的重要性 When used within a quality management system36ISO9000:2000 質(zhì)量管理體系應(yīng)用指南-第三部分管 理C D過 程 A輸出 支 持管 理過 程 B輸 入 內(nèi)部顧客 支 持APCD客 戶 反饋 客戶法律法規(guī) 輸如 輸如 MOODY INTERNATIONAL CER

34、TIFICATION LTD.304, Rainbow Building, Tuanjiehu Beisantiao, Beijing 100026, ChinaTel.: (0) 108597 8853Fax: (0) 10 85978857E-mail: adminisM process approach emphasizes the importance of:a)b)c)理解和滿足要求 the understanding and fulfillment of requirements, 需要考慮過程是否創(chuàng)造價值 the need to consider proce

35、sses in terms of added value, 獲得過程業(yè)績和有效性的結(jié)果 及 obtaining results of process performance and effectiveness, and d)根據(jù)對目標(biāo)的測量 measurement. 持續(xù)改進(jìn)過程 continual improvement of processes based on objective 在新標(biāo)準(zhǔn)中 過程方法包括產(chǎn)品實現(xiàn)所必須的過程 以及為保證質(zhì)量管理體系有效貫徹所必須的過程對這些過程的要求 新標(biāo)準(zhǔn)在下列章節(jié)中描述 Within the context of ISO 9001:2000, the

36、 process approach includes the processes needed for product realization, and the other processes needed for the effective implementation of the Quality Management System (QMS). Requirements for these processes are stated in the following clauses of the international standard: 45678質(zhì)量管理體系 Quality man

37、agement system 管理職責(zé) Management responsibility 資源管理 Resource management 產(chǎn)品實現(xiàn) Product realization 測量 分析和改進(jìn) Measurement, analysis and improvement質(zhì)量管理體系的總體要求在 ISO 9001:2000 標(biāo)準(zhǔn) 4.1 條款中描述 下面舉例說明組織在貫徹新標(biāo)準(zhǔn)時應(yīng)注意的問題 The general requirements for a QMS are defined in clause 4.1 of. Some guidance is given below on

38、 what an organization may choose to ask itself in order to address these requirements, though it is stressed that these are only examples, and should not be interpreted as the only way to meet the requirements: a) 明確質(zhì)量管理體系所必須的過程 及其在整個組織中的應(yīng)用 Identify the processes needed for thequality management sys

39、tem, and their application throughout the organization. 我們的質(zhì)量管理體系需要哪些過程 What are the processes needed for our QMS? 是否有那些過程向外分包 Are any of these processes outsourced? 每一個過程的輸入和輸出是什么 What are the inputs and outputs for each process? 每一個過程的供應(yīng)方和顧客是否明確 Who are the customers of the processes? 過程顧客的要求是否明確

40、What are the requirements of these customers? 過程的職責(zé)是否明確 Who is the owner of the process? b) 確定這些過程的順序的相互作用 Determine the sequence and interaction of these processes.我們所有過程的總體流程是什么 What is the overall flow of our processes? 我們怎樣描述這一流程 過程圖或流程圖 How can we describe this? (Process maps or flow-charts?)過程

41、之間的借口關(guān)系是什么 What are the interfaces between the processes? 我們需要哪些文件 What documentation do we need? c) 制定判定準(zhǔn)則和方法 確保過程的運作和控制有效 Determine criteria and methods required37ISO9000:2000 質(zhì)量管理體系應(yīng)用指南-第三部分MOODY INTERNATIONAL CERTIFICATION LTD.304, Rainbow Building, Tuanjiehu Beisantiao, Beijing 100026, ChinaTel

42、.: (0) 108597 8853Fax: (0) 10 85978857E-mail: adminisM ensuring that both the operation and control of these processes are effective 過程預(yù)期的和非預(yù)期的結(jié)果特性是什么 What are the characteristics of intended and unintended results of the process? 監(jiān)控 測量的分析的判定準(zhǔn)則是什么 What are the criteria for monitoring, mea

43、surement and analysis? 怎樣結(jié)合這些判定準(zhǔn)則 策劃質(zhì)量管理體系和產(chǎn)品實現(xiàn)過程 How can we incorporate this into theplanning of our QMS and product realization processes? 怎樣判定過程的經(jīng)濟(jì)性 成本 時間 浪費等 What are the economical issues (cost, time, waste, etc.)? 采用何種適當(dāng)?shù)姆椒ㄊ占^程信息和數(shù)據(jù) What methods are appropriate for data gathering? d) 確保提供必要的資源

44、的信息 支持過程的運作和監(jiān)控 Ensure the availability of resources andinformation necessary to support the operation and monitoring of these processes 每一個過程需要什么資源 What are the resources needed for each process? 怎樣建立信息交流渠道 What are the communication channels? 我們怎樣提供有關(guān)過程的內(nèi)部/外部信息 How can we provide external and inter

45、nal information about the process? 我們怎樣獲得反饋 How do we obtain我們收集什么過程數(shù)據(jù) What data do 我們保存哪些過程記錄 What recordsfeedback? we need to collect?do we need to keep?e) 測量 監(jiān)控和分析過程 Measure,monitor and analyze these processes.我們怎樣監(jiān)控過程的業(yè)績 過程能力 顧客滿意度 How can we monitor process performance (Process capability, cust

46、omer satisfaction)? 必須的測量方法有哪些 What measurements are necessary? 我們怎樣有效地分析所收集到的信息 采用哪些統(tǒng)計技術(shù) How can we best analyze gathered information (Statistical techniques)? 分析的結(jié)果給我們什么啟示 What does the result of this analysis tell us? f) 貫徹措施 達(dá)到預(yù)期的結(jié)果 并持續(xù)改進(jìn)過程 Implement action necessary to achieve plannedresults an

47、d continual improvement of these processes 我們怎樣改進(jìn)過程 How can we improve the process? 有哪些糾正和/或預(yù)防措施 What corrective and/or preventive actions are necessary? 這些糾正/預(yù)防措施是否得到貫徹 Have these corrective/preventive actions been implemented? 措施是否有效 Are they effective? 6過程的文件化 Documentation of processes每一個組織都有其管理和運作過程 管理活動起初僅限于是明確所有過程 并用最合適的方法進(jìn)行管理ISO 9001:2000 版標(biāo)準(zhǔn)要求所有質(zhì)量管理體系必須的過程都應(yīng)根據(jù) 4.1 條款 質(zhì)量體系總則要求進(jìn)行管理 但并沒有明確要求哪些過程應(yīng)文件化 組織應(yīng)根據(jù)其顧客 適用的法規(guī)要求 業(yè)務(wù)的特性及總體管理策略決定應(yīng)建立的管理文件 Processes exist within the organization and the initial approach 38ISO9000:2000 質(zhì)量管理體系應(yīng)用指南-第三部分MOODY INTERNATIONAL CERTIFICATION LT