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1、BSI Standards, 389 Chiswick High Road, London W4 4AL Telephone: + +44 208 996 9000 Fax: + +44 208 996 74001Our ref Secretariat of ISO/TC 176/SC 2Date: 15 October 2008ISO/TC176/SC2 秘书处日期： 2008 年 10 月 15 日ISO 9000 Introduction and Support Package: ISO9000 介绍和支持文件包：Guidance on the Concept and Use of th
2、e Process Approach for management systems 过程方法的概念及其在管理体系中应用的指南In conjunction with the publication of the International Standard ISO 9001:2008, ISO/TC 176/SC 2 has published a number of guidance modules: 为配合 ISO9000:2008 国际标准的发布， ISO/TC176/SC2 发布了一系列指南文件：Guidance on ISO 9001:2008 Sub-clause 1.2 Appli
3、cationISO9001:2008 条款 1.2“应用”的指南Guidance on the Documentation requirements of ISO 9001:2008ISO9001:2008 文件要求的指南Guidance on the Terminology used in ISO 9001 and ISO 9004ISO9001 和 ISO9004 使用术语的指南Guidance on the Concept and Use of the Process Approach for management systems过程方法的概念及其在管理体系中应用的指南Guidance
4、on Outsourced Processes“外包过程”的指南Together these are being made available as the ISO/TC 176/SC 2 “ISO 9000 Introduction and Support Package”. 以上指南均由 ISO/TC176/SC2 “ISO9000 介绍和支持文件包”提供。Feedback from users of the standards will be used to determine whether additional modules should be developed, or if t
5、hese published modules should be revised. 来自标准使用者的反馈，将用于决定是否开发新文件，或修订已发布文件。The modules, and further information on the ISO 9001:2008 standard, may be downloaded from the following web sites: 这些文件和 ISO9001:2008 的其他信息，可以从以下网址下载：www.iso.orgwww.iso.org/tc176/sc2C Corrie For the BSI Secretariat of ISO/TC
6、 176/SC 2 Document: ISO/TC 176/SC 2/N 544R3? ISO 2008 All rights reserved ISO/TC 176/SC 2/N 544R3 21) Introduction引言Key words: management system, process approach, system approach to management 关键词：管理体系、过程方法、管理的系统方法Content 目录1. Introduction 前言.22. What is a process? 什么是过程？ .33. Types of processes 过程
7、的类型 .44. Understanding the process approach 理解过程方法 .65. Implementing the process approach 过程方法的实施 .75.1 Identification of the processes of the organization 组织过程的确定.85.2 Planning the process 策划过程 .105.3 Implementation and measurement of the process 过程的实施和测量 .115.4 Analysis of the process 分析过程 .125.5.
8、 Corrective action and improvement of the process 纠正措施和过程改进.121. Introduction 前言This guidance document provides an understanding of the concepts, intent and the application of the “process approach” to the ISO 9000 family of Quality Management System standards. The guidance may also be used to apply
9、 the process approach to any management system regardless the type or the size of organization. This includes but is not limited to management systems for: 本指南帮助理解ISO9000 族质量管理体系标准所采用过程方法的概念、目的和应用，也可用于将过程方法应用于任何管理体系，无论组织的类型和规模。这包括，但不限于以下管理体系：Environment (ISO 14000 family),环境（ ISO14000族）Occupational
10、Health and Safety,职业健康安全Business Risk,商业风险Social Responsibility.社会责任This guide also aims to promote a consistent approach to the description of processes and use of process related terminology. 本指南的目的也在于促进对过程的阐述以及使用与过程有关术语的一致性。The purpose of the process approach is to enhance an organizations effect
11、iveness and efficiency in achieving its defined objectives. In relation to ISO 9001:2008 this means enhancing customer satisfaction by meeting customer requirements. 过程方法的目的是提高组织实现其所确定目标的有效性和效率。在ISO9001:2008中，这意味着通过满足顾客要求增强顾客满意。Benefits of the process approach are: 过程方法的好处在于：?Integration and alignme
12、nt of processes toenable achievement of desired outcomes整合和调整过程能实现期望的输出?Ability to focus effort on process effectiveness and efficiency.致力于关注过程有效性和效率的能力?Provision of confidence to customers, and other interested parties, about theconsistent performance of the organization.? ISO 2008 All rights reser
13、ved ISO/TC 176/SC 2/N 544R3 3在组织运作一致性方面，使顾客和其他相关方信任?Transparency of operations within the organization.组织内运作的透明性?Lower costs and creation of shorter cycle times, through the effective use of resources.通过有效地使用资源，以低成本在较短循环时间内实现?Improved, consistent and predictable results.改进的、一致的和可预期的结果?Provision of o
14、pportunities for focused and prioritized improvement initiatives.为关注的、优先的主动改进提供机会?Encouragement of the involvement of people and the clarification of theirresponsibilities.鼓励人们的参与和澄清他们的责任2. What is a process? 什么是过程？A “Process ” can be defined as a “set of interrelated or interacting activities, whic
15、h transforms inputs into outputs”. These activities require allocation of resources such as people and materials. Figure 1 shows a generic process. “过程”定义为“将输入转换为输出的相互关联或相互作用的一组活动”。这些活动要求配置诸如人和原料之类的资源。图1 表明了一个通用的过程。【译者按】：为帮助理解“活动” 概念，在此摘录了ISO/TC176/SC2 /N526R2:2008 ISO9001和 ISO9004 使用术语的指南中对“活动”含义的说
16、明：“活动，名词，为所追求的目的做某事”。 （另：“汉典”对“活动”的解释：有一定目的的行动）。相对“过程”而言，可以理解为， “活动”是其流程中单元，通常不再可分。A major advantage of the process approach, when compared to other approaches, is in the management and control of the interactions between these processes and the interfaces between the functional hierarchies of the o
17、rganization (as further explained in section 4). 与其他方法比较，过程方法的主要优点在于管理和控制过程之间的相互作用和组织各职能层次之间的接口（进一步的说明见第4 节）。EFFECTIVENESS OF PROCESS = Ability to achieve desired resultsInterrelated or interacting activities and control methodsMonitoring and MeasuringInputRequirements Specified(Includes resources)O
18、utputRequirements Satisfied(Result of a process)EFFICIENCY OF PROCESS = Results achieved vs. resources used输入规定的要求（包括资源）相互关联和相互作用的活动和控制方法监视和测量输出满足要求（过程结果）有效性效率Figure 1. A generic processInputs and intended outputs may be tangible (such as equipment, materials or components) or intangible (such as en
19、ergy or information). Outputs can also be unintended, such as waste or pollution. 输入和预期的输出可以是有形的（如设备、原料或其他组成），或无形的（如能力或信息）。输出也可以是非预期的，如废物和污染。? ISO 2008 All rights reserved ISO/TC 176/SC 2/N 544R3 4Each process has customers and other interested parties (who may be either internal or external to the
20、organization), with needs and expectations about the process, who define the required outputs of the process. 每个过程都有顾客和其他相关方（可以是组织内部或外部的），他们根据其对该过程的需要和期望，规定过程输出的要求。A system should be used to gather data to provide information about process performance, which should then be analyzed to determine if t
21、here is any need for corrective action or improvement. 体系应当收集和提供过程绩效的信息，然后分析决定过程是否需要采取纠正措施或改进。All processes should be aligned with the objectives, scope and complexity of the organization, and should be designed to add value to the organization. 所有过程都应当结合组织的目标、范围和复杂程度来整合，设计成为组织增值。Process effectivene
22、ss and efficiency can be assessed through internal or external review processes. 过程的有效性和效率可以通过内部或外部的评审过程来进行评价。3. Types of processes 过程的类型3.1 References to processes in ISO 9001:2008: ISO9001:2008 所述的过程ISO 9001:2008 states: ISO9001:2008指出：In sub clause 0.1 General: “The design and implementation of a
23、n organizations quality management system is influenced by: its business environment, changes in that environment, or risks associated with that environment; its varying needs; its particular objectives; the products it provides; the processes it employs; its size and organizational structure. It is
24、 not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation”. 条款 0.1 总则：“一个组织质量管理体系的设计和实施受下列因素的影响：a) 组织的环境、该环境的变化以及与该环境有关的风险；b) 组织不断变化的需求；c) 组织的具体目标；d) 组织所提供的产品； e) 组织所采用的过程；f) 组织的规模和组织结构。统一质量管理体系的结构或文件不是本标准的目的。”In
25、sub clause 0.2 Process Approach: “The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach “. 条款 0.2 过程方法：“为了产生期望的结果，由过程组成的系统
26、在组织内的应用，连同这些过程的识别和相互作用，以及对这些过程的管理，可称之为过程方法”。In sub clause 4.1 General requirements: “The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organi
27、zation shall: a) determine the processes needed for the quality management system and their applicationthroughout the organization (see 1.2), b) determine the sequence and interaction of these processes,c) determine criteria and methods needed to ensure that both the operation and control ofthese pr
28、ocesses are effective, d) ensure the availability of resources and information necessary to support the operation andmonitoring of these processes, e) monitor, measure (where applicable), and analyse these processes, andf) implement actions necessary to achieve planned results and continual improvem
29、ent ofthese processes. ? ISO 2008 All rights reserved ISO/TC 176/SC 2/N 544R3 5These processes shall be managed by the organization in accordance with the requirements of this International Standard”. 条款 4.1 总要求：“组织应按本标准的要求建立质量管理体系，将其形成文件，加以实施和保持，并持续改进其有效性。组织应：a) 确定质量管理体系所需的过程及其在整个组织中的应用（见1.2）；b) 确定
30、这些过程的顺序和相互作用；c) 确定所需的准则和方法，以确保这些过程有效的运行和控制有效；d) 确保可以获得必要的资源和信息，以支持这些过程的运行和监视；e) 监视、测量（适用时）和分析这些过程；f) 实施必要的措施，以实现所策划的结果和对这些过程的持续改进。组织应按本标准的要求管理这些过程。”Based on the above, each organization should define the number and type of processes needed to fulfil its business objectives. It is permissible for a p
31、rocess that is required by ISO 9001:2008 to be part of a process (or processes) that is already established by the organization, or to be defined by the organization in terms that are different to those in ISO 9001. 基于上述要求，每个组织应当规定满足其经营目标所需的一系列各种类型的过程。对ISO 9001:2008所要求的过程，允许组织按其建立的过程来划分，或以不同于ISO9001
32、 的组织自己的术语来定义。3.2 Typical types of processes that can be identified: 可以识别的过程典型类型In accordance with 3.1 above, organizations have to define the number and types of processes needed to fulfil their business objectives. While these will be unique to each organization, it is however possible to identify
33、typical processes, such as: 根据上述3.1，组织必须确定满足其经营目标所需过程的数量和类型。过程对组织是唯一的，然而，它们的类型可以识别，如：-Processes for the management of an organization. These include processes relating to strategic planning, establishing policies, setting objectives, ensuring communication, ensuring availability of resources for the
34、 other organizations quality objectives and desired outcomes and for management reviews. 组织的管理过程。所包括的这些过程与以下方面有关：战略策划、建立方针、设定目标、确保沟通、确保为实现其他组织的质量目标和期望的输出以及为管理评审提供资源。-Processes for managing resources. These include all the processes that are necessary to provide the resources needed for the organizat
35、ions quality objectives and desired outcomes. 资源管理过程。包括组织提供实现其质量目标和期望输出所需资源而必要的所有过程。-Realization processes. These include all processes that provide the desired outcomes of the organization. 产品实现。包括组织提供期望输出的所有过程。-Measurement, analysis and improvement processes. These include the processes needed to
36、measure and gather data for performance analysis and improvement of effectiveness and efficiency. They include measuring, monitoring, auditing, performance analysis and improvement processes (e.g. for corrective and preventive actions). Measurement processes are often documented as an integral part
37、of the management, resource and realization processes; whereas analysis and improvement processes are treated frequently as autonomous processes that interact with other processes, receive inputs from measurement results, and send outputs for the improvement of those processes. 测量、分析和改进过程。包括测量和收集数据以
38、实施分析和改进有效性和效率所需的过程。它们包括测量、监视、审核、绩效分析和改进过程（如：纠正措施和预防措施）。测量? ISO 2008 All rights reserved ISO/TC 176/SC 2/N 544R3 6过程文件化时通常作为管理、资源和实现过程整体的一部分，而分析和改进过程经常作为单独的过程，它接受来自测量过程的输入，为改进这些过程提供输出。4. Understanding the process approach 理解过程方法A process approach is a powerful way of organizing and managing activitie
39、s to create value for the customer and other interested parties. 过程方法是对活动进行整合和管理，为顾客和其他相关方创造价值的强有力方法，Organizations are often structured into a hierarchy of functional units. Organizations are usually managed vertically, with responsibility for the intended outputs being divided among functional unit
40、s. 组织经常采用各层次职能单元式的结构，通常是按预定的输出规定这些职能单元的职责，进行垂直管理。The end customer or other interested party is not always visible to all involved. Consequently, problems that occur at the interface boundaries are often given less priority than the short-term goals of the units. This leads to little or no improvemen
41、t to the interested party, as actions are usually focused on the functions, rather than on the intended output. 对组织的所有部门来说，并非都是与最终顾客或其他相关方直接相关。因此，对职能界限接口上产生问题根本不予优先关注，而更关注职能部门的短期目的。对所有相关方来说，这就导致了很少有或没有改进，因为要采取的措施通常关注的是自己的职能，而不是最终输出。The process approach introduces horizontal management, crossing the
42、barriers between different functional units and unifying their focus to the main goals of the organization. 过程方法引入了平行的管理，跨越不同职能单元间的屏障，将他们的关注点统一于组织的主要目标。It also improves the management of process interfaces (see Figure 2). 这改进了对过程接口的管理（见图2）Figure 2. Example of Process linkages across departments in a
43、n organization. 图 2. 组织内跨部门过程连接的例子The performance of an organization can be improved through the use of the process approach . The processes are managed as a system defined by the network of the processes and their interactions, thus creating a better understanding of added value. 组织的运作可以通过过程方法的应用来得
44、到改进。过程作为过程网络及其相互作用的系统来管理，可以更好地创造对增值的理解。Note: The consistent operation of this network is often referred to as the system approach to management. 注：过程网络的一致运作，通常称为管理的“系统方法”。? ISO 2008 All rights reserved ISO/TC 176/SC 2/N 544R3 7Often the outputs from one process can be the inputs into other processes
45、 and are interlinked into the overall network or system (for generic examples, see Figure 3 and Figure 4). 一个过程的输出可以是其他过程的输入，它们的连接构成了整个网络或系统（作为通用的例子，见图 3 和图 4）PROCESS A PROCESS CPROCESS BPROCESS D Inputsto AInputs to BOutputsfrom AInputs to COutputsfrom COutputsfrom BInputs to DOutputsfrom DOutputs
46、fromother processesOutputs fromother processesFigure 3. Example of a generic process sequence 图 3. 过程系统的通用例子Figure 4. Example of a process sequence and its interactions. 图 4. 过程系统及其相互作用的例子5. Implementing the process approach 过程方法的实施IIIIResource ProcessesProduct DesignProcess DesignProject PlanningPr
47、oductionManagement ProcessesMeasurement, Analysis, and ImprovementOIIOIOOIOOOO? ISO 2008 All rights reserved ISO/TC 176/SC 2/N 544R3 8The following implementation methodology can be applied to any type of process. The step sequence is only one method and is not intended to be prescriptive. Some step
48、s may be carried out simultaneously. 以下的实施方法可以应用于任何类型的过程。步骤的顺序仅仅是一种方法，并非规定，一些步骤可以同时实施。5.1 Identification of the processes of the organization 组织过程的确定Steps in the process approach 过程方法的步骤What to do? 做什么？Guidance 指南5.1.1 Define the purpose of the organization 确定组织的意图The organization should identify it
49、s customers and other interested parties as well as their requirements, needs and expectations, to define the organizations intended outputs. 组织应当确定其顾客和其他相关方，以及他们的要求、需求和期望，以规定组织期望的输出Gather, analyze and determine customer and other interested parties requirements, and other needs and expectations. Co
50、mmunicate frequently with customers and other interested parties to ensure continual understanding of their requirements, needs and expectations. 收集、分析和确定顾客和其他相关方的要求，以及其他需求和期望。经常与顾客和其他相关方沟通，以确保持续地理解他们的要求、需求和期望。Determine the requirements for quality management, environmental management, occupational