1. Introduction 引言
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 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:
本指导文件用于贯彻ISO9000系列质量管理体系标准时，理解“过程模式”的概念、意图和应用。也可以应用于其他任何管理体系，不管什么类型和规模大小。其中包括，还不限制于以下管理体系：
Environment (ISO 14000 family), 环境保护体系ISO 14000，
Occupational Health and Safety, 职业健康和安全体系，
Business Risk, 商务风险管理体系，
Social Responsibility.社会责任管理体系，
This guide also aims to promote a consistent approach to the description of processes and use of process related terminology.
本指导文件还有的目的是促进对过程以及过程有关术语一致性的描述和运用。
The purpose of the process approach is to enhance an organization’s effectiveness and efficiency in achieving its defined objectives. In relation to ISO 9001:2008 this means enhancing customer satisfaction by meeting customer requirements.
采用过程模式的目的是，为了组织在实现他们规定的目标过程中，提高有效性和效率。结合ISO9001：2008标准，意味着通过满足顾客的各项要求来提高顾客的满意。
Benefits of the process approach are:
采用过程模式的好处是：
Integration and alignment of processes to enable achievement of desired outcomes 整合各个过程，让各个过程方向一致，从而能达到预期的输出。
Ability to focus effort on process effectiveness and efficiency.能把精力集中到过程的有效性和效率。
Provision of confidence to customers, and other interested parties, about the consistent performance of the organization. 向顾客和其他利益相关方提供信心，有关组织具有持续一贯绩效的信心（译者：意思是今天行，明天后天都会行）。
Transparency of operations within the organization.在组织内部各项操作的透明度。
Lower costs and creation of shorter cycle times, through the effective use of resources.通过对各种资源的有效利用，降低成本和缩短周期时间。
Improved, consistent and predictable results.能持续改进和连续一贯地达到预测的各项结果。
Provision of opportunities for focused and prioritized improvement initiatives.在有限的各种改进机会中排队、确定、发起改进措施。
Encouragement of the involvement of people and the clarification of their responsibilities 鼓励人员改进和便于澄清员工之间相互的工作职责。.
2. What is a process? 什么叫过程？
A “Process” can be defined as a “set of interrelated or interacting activities, which transforms inputs into outputs”. These activities require allocation of resources such as people and materials. Figure 1 shows a generic process.
过程是“一套相互关联或作用的活动，这些活动把各种输入转化为输出”。这些活动要求给它们提供诸如人员和材料等资源。图1展示一般的过程。
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 organization (as further explained in section 4).
采用过程模式主要的好处是，当它和其他方法来对比，就在于在这些过程和过程之间的相互作用以及各种职能组织之间的接口方面便于管理和控制（进一步的解释请见第4条）。
Figure 1 - Generic process 图1展示一般的过程
Inputs and intended outputs may be tangible (such as equipment, materials or components) or intangible (such as energy or information). Outputs can also be unintended, such as waste or pollution.
各种输入和意向的输出可以是有形的（诸如设备、材料或者部件）或者是无形的（诸如能量或者信息）。各种输出也可能是非意向要的，譬如，废物或对环境的污染。
Each process has customers and other interested parties (who may be either internal or external to the 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利益相关者（他们可能是组织内部的或者是外部的），他们对过程都有需求和期望，因此，他们对过程的输出定义各项要求。
A system should be used to gather data to provide information about process performance, which should then be analyzed to determine if there is any need for corrective action or improvement.
应当利用一个系统来收集数据，以便提供有关过程绩效的信息，这些信息应当加以分析来确定，是否需要采取纠正措施或者改进过程。
All processes should be aligned with the objectives, scope and complexity of the organization, and should be designed to add value to the organization.
所有的过程应当向着统一的目标、组织的范围和复杂性努力，而且应当设计成能为组织增值的。
Process effectiveness and efficiency can be assessed through internal or external review processes.
可以通过内部和外部来对过程进行评估确定过程的有效性和效率。
3. Types of processes 过程类型
3.1 References to processes in ISO 9001:2008:
参考ISO9001：2008中的各种过程
ISO 9001:2008 states:
ISO9001：2008标准0.1条《总则》中说：
In sub clause 0.1 General: “The design and implementation of an organization‘s 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 not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation”.
“一个组织设计和执行一个质量管理体系将受到以下各个方面的影响：他们的商务环境、这些环境的变更、或者与该环境有联系的各种风险、组织自己在变化着的各种需求、组织特定的目标、组织提供的产品、他们所采用的各种过程。本国际标准的意图不在于强行统一质量管理体系的结构整齐划一，也不是要文件化的统一。”
In 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“.
“在ISO9001：2008第0.2条《过程模式》中讲，一个组织应用各种过程组成的体系，再识别这些过程和让这些过程相互作用，加以管理来产生期望要得到的各个输出，这就叫‘过程模式’。”
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 organization shall:
标准第4.1条对体系提出《总的要求》中要求：“组织应根据本国际标准规定的各项要求，建立、文件化、执行和维持一个质量管理体系，而且要持续改进该体系的有效性。组织应：
a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2),
为质量管理体系确定各个必需的过程（见第1.2条），并在整个组织内加以应用
b) determine the sequence and interaction of these processes,
确定这些过程的先后顺序和相互作用。
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
确定为了确保对这些过程有效地运作和控制所必需的判别准则和各种方法。
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
确保能获得必要的各种资源和信息，用来支持这些过程的运作和监视这些过程。
e) monitor, measure (where applicable), and analyse these processes, and
监视、测量（凡是应当测量的）和分析这些过程，和
f) implement actions necessary to achieve planned results and continual improvement of these processes.
只系各项必要的措施来达到策划要求达到的各个结果和持续改进这些过程。
These processes shall be managed by the organization in accordance with the requirements of this International Standard”.
这些过程 应由组织根据本国际标准的各项要求加以管理。”
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 process 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.
根据以上各种要求，每个组织应当定义一系列和各种类型的过程，这些过程都是为了实现组织自己商务目标所必需的过程。这些ISO9001：2008所要求的某一个过程容许是组织已经建立好的一个（或者多个）过程，或者，也可以由组织自己给它所起的名称，这个名称和ISO 9001所叫的名称不同。（译者：意思是组织现在有的过程，即使名称叫得不同，如果满足ISO9001：2008要求，可以继续使用。没有必要从头再来建立这样的过程。）
Typical types of processes that can be identified:
可加以识别的各种典型类型的过程
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 typical processes, such as:
根据前面第3条，组织为了实现他们的商务目标，必须定义一系列不同类型的过程。而这些过程对不同组织都是不同的，但是，有可能识别出典型的过程，诸如：
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 other organization’s quality objectives and desired outcomes and for management reviews.
一个组织的管理过程。这些过程包括有战略规划、制定各种方针、确定各种目标、确保沟通、确保各种资源获得、以及为了确保组织质量管理目标和期望得到的各种输出和管理评审有关的各种过程。
Processes for managing resources. These include all the processes that are necessary to provide the resources needed for the organization’s quality objectives and desired outcomes.
对资源的管理过程。这些过程包括为组织实现质量管理体系目标和期望得到的各种输出所必需要的资源提供过程。
Realization processes. These include all processes that provide the desired outcomes of the organization.
产品实现过程。这些过程包括组织为所有期望得到各种输出而提供的过程。
Measurement, analysis and improvement processes. These include the processes needed to 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 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。这些过程包括组织为了测量和收集绩效分析和改进有效性和效率所用各种数据而必须的过程。这些过程还包括测量、监视、审核、绩效分析和改进（例如纠正措施和预防措施）过程。测量过程常常是文件化的，作为管理过程、资源提供过程和产品实现过程的一个整体组成部分。而分析和改进过程往往把它处理为自动进行各种过程。这些过程和其他有关过程相互作用的，从其他过程那里通过测量得到各种过程的输入，通过分析再提供各种输出，改进这些过程。
4 Understanding the process approach理解过程模式
A process approach is a powerful way of organizing and managing activities to create value for the customer and other interested parties.
过程模式对组织来说，是一种很有力管理各项作业（活动），为顾客和其他利益相关方创造价值的途径。
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 units.
各个组织通常采用由各种职能单位为主组成的层级式的结构。通常采用上下垂直的管理方式，把整个组织期望的各种输出分割成各个职能单位所负责的输出，然后，各个职能单位对各自部分负责。
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 improvement to the interested party, as actions are usually focused on the functions, rather than on the intended output.
对最终的顾客或者外部的利益相关方来说，总是看不到所有有关者。其结果是，在各个职能边界之间产生的各种问题往往会比作为一个单位短期目的需要解决的问题来说，排不上队，无法得到及时的解决。这样的结果，所采取的各种措施通常都是针对职能的，不会关注总的期望得到的结果，对整体来说，根本没有什么结果或者很少有所改进。
The process approach introduces horizontal management, crossing the barriers between different functional units and unifying their focus to the main goals of the organization.
过程模式是强化水平管理，消除不同职能单位之间的各种障碍，把各个职能的精力引向组织主要的目的。
It also improves the management of process interfaces (see Figure 2).
过程模式同时也改进了过程和过程交界面的管理。（见图2）
Figure 2 - Example of Process linkages across departments in an organization.
图2=组织中跨部门联系的过程实例
The performance of an organization can be improved through the use of the process approach. The processes are managed as a system, by creating and understanding a network of the processes and their interactions.
一个组织的绩效可以通过过程模式来加以改进的。把过程组成一个网络，理解各个过程之间的相互作用，然后，把各个过程组成一个系统加以管理。
Note: The consistent operation of this network is often referred to as the "system approach" to management.
注：这个网络的协调一致工作方法通常就叫“系统方法”来管理。
The outputs from one process may be inputs to other processes and interlinked into the overall network or system (for generic examples, see Figure 3 and Figure 4).
从某一过程的各个输出可以成为另外几个过程的输入，这样，把所有过程组成一个网络，或叫系统（总的方面来看，见图3和图4所示）。
Figure 3 - Example of a generic process sequence
图3-一般过程的顺序示意图
Figure 4 - Example of a process sequence and its interactions
图4-某一过程的顺序和它的相互作用示意图
5. Implementing the process approach 如何贯彻过程模式
The 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 steps may be carried out simultaneously.
以下贯彻方法可以适用于任何类型的过程（译者注：任何类型的过程是指产品实现过程、资源提供过程、测量分析过程、改进过程和管理者管理过程）。按照步骤顺序只是一种方法而已，不是必须这样做的。一些步骤可以同时执行的。
5.1. Identification of processes of the organization 识别组织的过程。
Steps in the process approach What to do? Guidance
指导这一方面的各个步骤做些什么工作：
5.1.1Define the purpose of the organization 定义组织的目的
The organization should identify its customers and other interested parties as well as their requirements, needs and expectations to define the organization's intended outputs. Gather, analyze and determine customer and other interested parties requirements, and other needs and expectations. Communicate frequently with customers and other interested parties to ensure continual understanding of their requirements, needs and expectations.
组织应当识别他们的顾客和其他利益相关方，包括他们的各种要求、需求和期望，根据这些来确定组织的意向输出是什么。收集、分析和决定顾客和他们利益相关方的各种要求和他们的需求和期望。频频地和顾客们和利益相关方进行沟通，确保持续理解他们的各种要求和他们的需求和期望。
Determine the requirements for quality management, environmental management, occupational health and safety, management, business risk, social responsibilities and other management system disciplines that will be applied within the organization.
确定质量管理、环境管理、员工健康以及安全管理和商务风险、社会责任以及组织将要在他们组织内应用的其他各种管理体系的原则。
5.1.2 Define the policies and objectives of the organization
确定组织的方针和目标
Based on analyses of the requirements, needs and expectations, establish the organization's policies and objectives Top management should decide which markets the organization should address and develop relevant policies. Based on these policies, management should then establish objectives for the intended outputs (e.g. products, environmental performance, occupational health and safety performance)
根据对这些要求、需求和期望的分析建立组织的方针和目标。最高管理者应当决定组织哪个市场应当开发有关的方针。根据这些方针，管理者应当为期望的输出建立各种（也就是各种产品、环境性能、健康、安全性能的）目标。
5.1.3 Determine the processes in the organization
确定组织为了实现这些目标必须的所有过程
Determine all the processes needed to produce the intended outputs. Determine the processes needed for achieving the intended outputs. These processes include Management, Resources, Realization and Measurement, Analysis and Improvement.
确定组织为了实现这些目标必须的所有过程。这些过程包括管理过程、资源的过程、产品实现过程、测量、分析和改进过程。
Identify all process inputs and outputs, along with the suppliers, customers and other interested parties (who may be internal or external).
从供方那里开始，到顾客为止，以及其他利益有关方（这些可能是内部的或者外部的），识别这些过程的输入和输出。
5.1.4 Determine the sequence of the processes
确定这些过程的先后顺序
Determine how the processes flow in sequence and interaction Define and develop a description of the network of processes and their interaction.Consider the following:
确定这些过程的先后流动的顺序和相互的作用。定义和开发一个描述过程组成的网络，描述它们的相互作用。做这工作时候考虑如下：
- The customer of each process, 每个过程的顾客是谁
- The inputs and outputs of each process,每个过程的输入和输出有哪些
- Which processes are interacting,哪些过程之间发生作用的
- Interfaces and what are their characteristics,过程和过程的交界面有哪些以及它们有哪些特性
- Timing and sequence of the interacting processes,把每个过程的时间和结果是什么定下来
- Effectiveness and efficiency of the sequence.这些结果的有效性和效率要求定下来
Note: As an example, a realization process that results in an output, such as product delivered to a customer, will interact with other processes (such as the management, measurement and monitoring, and resource provision processes).
Methods and tools such as block diagrams, matrix and flowcharts can be used to support the development of process sequences and their interactions.
注：作为一个例子，产品实现过程用输出作为各种，诸如交付给顾客的产品，将会和其他过程（譬如管理过程、测量和监视过程和资源提供过程）发生相互作用。各种方法和工具，诸如方块图、矩阵图、流程图都能用来支持过程顺序以及过程和过程相互作用的开发。
5.1.5 Define process ownership
指定过程的主管
Assign responsibility and authority for each process Management should define individual roles and responsibilities for ensuring the implementation, maintenance and improvement of each process and its interactions. Such an individual is usually referred to as the "process owner".
To manage process interactions, it may be useful to establish a "process management team", that has an overview across all the processes, and which includes representatives from each of the interacting processes.
针对每个过程明确职责和权限。管理者应当定义每个人的作用以及职责，确保过程的执行、维持和改进，以及和其他过程的相互作用。这个人通常叫“过程主管”。
为了管理过程的相互作用，也许建立一个“过程管理团队”很管用的。这个团队可以横向评审所有过程，其中包括来自相互作用的其他过程的代表。
5.1.6 Define process documentation
定义过程的文件
Determine those processes that are to be documented and how they are to be documented. Processes exist within the organization and the initial approach should be limited to identifying and managing them in the most appropriate way.
确定那些过程应当加以文件化，以及如何文件化。组织现有的各种过程和打算新开发的过程都应当用最合适的途径来控制文件的标识和管理好这些文件。
There is no "catalogue", or list of processes, that have to be documented.
The main purpose of documentation is to enable the consistent and stable operation of the processes.
没有现成的“目录”或者“清单”，规定哪些是必须文件化的。文件化的主要目的是能够确保操作过程的一致性和稳定性。
The organization should determine which processes are to be documented, on the basis of:
组织应当根据以下因素来确定哪些过程要求文件化：
- The size of the organization and its type of activities,组织规模和活动类型，
- The complexity of its processes and their interactions,过程和它们相互作用的复杂性，
- The criticality of the processes, and 过程的临界严重性，以及
- The availability of competent personnel.有能力人员的可获得性。
When it is necessary to document processes, a number of different methods can be used such as graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods.
当过程必须加以文件化的时候，可以采用一系列不同的方法，譬如，用图形来表示、书面文字方式、检查单、流程图、目视方式或电子方法。
Note: For more guidance see the ISO 9000 Introduction and Support Package module Guidance on the Documentation Requirements of ISO 9001:2008
更详细的请参考有关ISO9001：2008文件化指南的文章（译者：本网站可以得到）。
5.2 Planning of a process 过程的策划
Steps in the process approach What to do? Guidance
指导这一方面的各个步骤做些什么工作：
5.2.1Define the activities within the process
定义过程中的各个作业（活动）
Determine the activities needed to achieve the intended outputs of the process Define the required inputs and outputs of the process.
Determine the activities required to transform the inputs into the required outputs.
确定过程中为了达到过程输出所必须要有的各个作业（活动）。定义过程输入和输出的各项要求。确定把输入转化为满足要求的输出所必须要有的各个活动。
Determine and define the sequence and interaction of the activities within the process.
确定和定义过程中这些活动的先后顺序和相互作用。
Determine how each activity will be performed.
确定每个活动是如何执行的。
Note: In some cases, the customer may specify the way the process is to be performed.
注：某些情况下，顾客可能会规定过程的执行途经的。
5.2.2 Define the monitoring and measurement requirements
确定监视和测量的各种要求
Determine where and how monitoring and measuring should be applied. This should be both for control and improvement of the processes and the intended process outputs. Monitoring is always applicable but measurement may not be practicable or even possible. Nevertheless measurement gives more objective data on the performance of the process and it is a powerful management and improvement tool.
确定在什么地方和如何来监视和测量过程。这应当既要控制，又要改进过程，同时又要得到预期的输出。监视总是能加以应用的，而测量也许不现实的，或者甚至不可能测量的。不管如何，通过测量能得到更过的有关过程性能的客观数据，这是一中有力的管理和改进工具。
Determine the need for recording results. Identify the measures and monitoring criteria for process control and process performance, to determine the effectiveness and efficiency of the process, taking into account factors such as:
- Conformity with requirements,
确定过程控制和过程性能用的判别准则，同它来确定过程的有效性和效率。当确定判别准则的时候，应当从以下各个因素来考虑：
- Customer satisfaction,顾客的满意
- Supplier performance,供方的绩效
- On time delivery,及时交付率
- Lead times,订货提前量
- Failure rates,失效率
- Waste, 各种浪费
- Process costs,过程的各种成本
- Incident frequency. 事故发生频率
5.2.3 Define the resources needed
定义各种必要的资源
Determine the resources needed for the effective operation of each process Examples of resources include:
确定为了有效运作么个过程所必需的各种资源。举例如下：
- Human resources, 人力资源，
- Infrastructure,基础设施，
- Work environment,工作环境，
- Information,信息，
- Natural resources,自然资源，
- Materials,原材料，
- Financial resources 财务资源。
5.2.4 Verify the process and its activities against its planned objectives
力针对策划确定的目标来验证过程和它的活动的有效性
Confirm that the characteristics of the processes are consistent with the purpose of the organization (see 5.1.1) Verify that all the requirements identified in 5.1.1 are satisfied. If not, consider what additional process activities are required and return to 5.2.1 to improve the process.
肯定过程的各个特性和组织（见前面5.1.1）中的目的一致的。验证所有的前面5.1.1条中确定的要求都已经满足。如果没有满足的话，要考虑附加的过程活动，或者回到第5.2.1条改进过程。
5.3. Implementation and measurement of the process
执行和测量过程
Implement the processes and their activities as planned.
按照策划规定执行过程和过程中各个活动。
The organization may develop a project for implementation that includes, but is not limited to
为了执行过程，组织有可能要开发一个专题项目，其中应当考虑有，但是不限于以下的活动：
Communication, 沟通，
Awareness, 质量意识教育，
Training, 培训，
Change management,变更管理，
Management involvement, 管理者的参与，
Applicable review activities.应当采用的各种评审活动。
Apply the controls, and perform the monitoring and measurements as planned.
应用各种控制，并且按照策划安排执行各种监视和测量。
5.4. Analysis of the process
分析过程
Analyze and evaluate process information obtained from monitoring and measuring data, in order to quantify process performance. Where appropriate, use statistical methods.
分析和评估过程的信息，这些信息来自监视和测量得到的数据，其目的是为了定量的了解过程的绩效。凡是适用的地方应当采用统计技术方法来分析。
Compare the results of process performance information with the defined requirements of the process, to confirm process effectiveness and efficiency and to identify any need for corrective action.
把过程绩效的各种信息的结果和所定义的过程要求进行对比，肯定过程有效性和效率，然后，识别什么地方必须采取纠正措施，加以改进。
Identify process improvement opportunities based on the results of the analysis of process information.
根据对过程信息进行分析得到的结果，从中识别过程改进的各种机会。
Report to top management, and other relevant people in the organization, on the performance of the process, as appropriate.
向最高管理者和组织中其他有关人员报告有关过程绩效的适当的情况。
5.5. Corrective action and improvement of the process
执行纠正措施和改进过程
Whenever corrective actions are needed, the method for implementing them should be defined. This should include the identification and elimination of the root causes of the problems (e.g. errors, defects, lack of adequate process controls). The effectiveness of the actions taken should be reviewed. Implement the corrective actions and verify their effectiveness according to plan.
不管什么时候，当纠正措施是必需加以执行的话，执行纠正措施的方法应当加以规定。这种方法应当包括识别和消除产生问题（譬如，各种差错、缺陷、过程控制的充分性不足）的各种根本原因。所采取纠正措施的有效性应当加以评审。根据策划安排来执行纠正措施，和验证纠正措施的有效性。
When planned process outcomes are being achieved and requirements fulfilled, the organization should focus its efforts on actions to improve process performance to higher levels, on a continual basis.
当策划要达到的过程输出正在达到，要求得到满足的时候，组织应当把精力放在改进过程的绩效上，持续地提高过程绩效水平。
The method for improvement should be defined and implemented (examples of improvements include: process simplification, enhancement of efficiency, improvement of effectiveness, reduction of process cycle time). Verify the effectiveness of the improvement.
改进的方法应当加以规定，而后按照规定执行（举例说，改进方法包括：过程的简化、提高效率、提高有效性、降低过程的周期时间）。验证改进的有效性。
Risk analysis tools may be employed to identify potential problems. The root cause(s) of these potential problems should also be identified and eliminated, preventing occurrence in all processes with similarly identified risks.
可以利用各种风险分析工具来识别潜在的各种问题。这些潜在问题的根本原因（可能不止一个）也应当加以识别出来，用类似的各种识别风险的方法来预防所有各个过程中的潜在问题根本原因的发生，加以消除。
The Plan-Do-Check-Act (PDCA) methodology can be a useful tool to define, implement and control corrective actions and improvements. Extensive literature exists about the PDCA cycle in numerous languages.
PDCA方法是很有用的工具，可以用来定义、执行和控制各种纠正措施和改进。有大量的文件来描述PDCA如何做的。
PLAN >> Establish the objectives and processes necessary to deliver results in accordance with customer, statutory and regulatory requirements and the organization's policies; P=策划。建立目标和必要的过程来得到结果，满足顾客、法定要求和组织方针。
DO >> Implement the processes;D=执行。执行上面确定的各个过程。
CHECK >> Monitor and measure processes and product against policies,objectives and requirements for the product and report the results;C=检查。针对方针、目标和产品的各项要求监视和测量过程和产品，并且报告结果。
ACT >> Take actions to continually improve process performance;A=措施。持续执行改进过程绩效的各种措施。”
The PDCA is a dynamic methodology that can be deployed within each of the organization’s processes and across their interactions. It is intimately associated with planning, implementation, verification and improvement.
PDCA是一种动态的方法，能针对每个组织的过程和各个过程之间来运用。它必须在策划、执行、验证和改进之间紧密协调的。
Maintaining and improving process performance can be achieved by applying the PDCA concept at all levels within an organization. This applies equally to all processes, from high-level strategic processes to simple operational activities.
可以在组织各个层次采用PDCA概念来维持和改进过程的绩效。这种方法从高层次的战略过程到最简单的操作活动都是适用的。
以下摘自常见问题的回答中有关过程模式系统管理的内容，供参考：
41. What is the difference between a "process" and a "procedure"?
“过程”和“程序”的差别是什么？A "process" may be explained as a set of interacting or interrelated activities, which are employed to add value. A "procedure" is a method of describing the way or How in which all or part of that process activities shall/should be performed.
“过程”可以解释为一组相互关联或作用的活动（作业），这些活动是用来增值的。“程序”是一种描述途径的方法，或者说在程序中所有的或部分的过程活动必须/应当如何执行的。ISO 9000:2005 defines a procedure as a "specified way to carry out an activity or a process", which does not necessarily have to be documented.
标准ISO9000：2005把程序定义为，“执行一个活动或一个过程的途径”，这个程序不是必须要成文的。42. An organization has a well-established set of procedures. Can these procedures be used to help describe its processes?
一个组织具有一系列建立得很好的程序。这些程序能否用来帮助描述他们的过程？Yes, if the procedures describe inputs and outputs, appropriate responsibilities, controls and resources needed to satisfy customer requirements.
可以的。只要各种程序描述了各个输入和输出，适当地规定了职责、控制和各种为了满足顾客各种要求所必需的资源。43. What documentation is required by ISO 9001?
ISO9001要求有哪些文件化的要求？ISO 9001:2008 refers specifically to only 6 documented procedures; however, other documentation (including more documented procedures not specifically mentioned in ISO 9001:2008) may be required by an organization, in order to manage the processes that are necessary for the effective operation of the quality management system. This will vary depending on the size of the organization, the kind of activities in which it is involved and their complexity. For further guidance, please also refer to the ISO 9000 Introduction and Support Package module "Guidance on the Documentation Requirements of ISO 9001:2008"
ISO9001：2008特别提到的只有六份文件化的程序；但是，组织有可能要有更多的其他文件（包括ISO9001：2008标准中没有特定提到的，更多的文件化程序），管理这些过程以便有效的运作质量管理体系。这些取决于组织的规模大小、活动的类型和它们的复杂性。进一步指导内容请见ISO9000介绍和支持类文件中有一份文件，叫《ISO9001：2008关于文件化的指南》。45. What does an organization need to do to comply with ISO 9001?
为了符合标准ISO9001，组织必须做些什么工作？
When initially starting to use ISO 9001, an organization should familiarize its personnel with the Quality Management Principles, analyze the standards (especially ISO 9000 and ISO 9004), and consider how their guidance and requirements may affect your activities and related processes. If it then wishes to proceed to registration/certification, it should perform a gap analysis against the requirements of ISO 9001 to determine where its current quality management system does not address the applicable ISO 9001:2008 requirements, before developing and implementing additional processes to ensure that compliance will be achieved.
当组织发起采用ISO9001的时候，组织应当让员工熟悉质量管理原则，分析这套系列标准（特别是ISO9000和ISO9004），看看这些指南和标准提出的各项要求有可能对您们的工作作业和有关的过程将发生什么影响。假如希望通过认证注册的话，在开发和执行附加的各个过程之前，应当根据ISO9001标准要求，先分析一下现在的过程距离标准要求有多少差距，确定在什么地方现在的质量管理体系没有满足ISO9001：2008标准提出应用的各项要求，以便确保符合要求。54. Is an organization's ISO 9001 certificate applicable to all of its products ?
在一个组织内，ISO 9001证书能应用于所有的产品吗？
When an organization seeks to have its quality management system registered/certified to ISO 9001:2008, it is required to agree a "scope of certification" with its registrar/certification body. This will define the products to which the organization's quality management system is applicable, and against which it will be assessed. An organization is not obliged to include within its "scope of certification" all the products that it provides (note that the ISO 9000:2005 definition of "Product" includes "services"), but may be selective about those that are included. All applicable requirements of ISO 9001:2008 will need to be addressed by the organization's quality management system that covers those products that are included in the "scope of certification".
当组织申请他们的质量管理体系按照ISO9001：2008认证/注册的时候，认证机构要和您们协商一致，确定一个“认证范围”。这个范围内定义用组织质量管理体系应用的哪些产品，将针对这些产品进行评估。没有要求组织所有的产品都包括在这个“认证范围”。但是（注：根据ISO9000：2005对“产品”的定义，它包括“服务”在内），也许有选择的要包括那些服务在内。所有ISO9001：2008标准应用的要求将必须在组织覆盖“认证范围”中提及的那些产品的质量管理体系中加以说明。Customers should ensure that a potential supplier's "scope of certification" covers the products that they wish to order. Caveat Emptor!
顾客应当确保潜在的供方质量管理体系的“认证范围”中应当包括他们想要订货的那些产品。提醒使用者！57. What will happen to the ISO handbook “ISO 9001 for Small Businesses”?
ISO9001：2008出版对小型组织手册会有什么影响吗？It remains fully applicable. A project has been started to update the handbook to reflect the changes in ISO 9001:2008.
完全适用，没有影响。已经成立了一个专题项目，反映ISO9001：2008的各种更改。58. What’s the relationship between the revised ISO 9001 and ISO 14001?
修改后的ISO 9001和ISO 14001：2004之间有什么关系？Compatibility with ISO 14001:2004 has been maintained and enhanced. “Compatibility” means that common elements of the standards can be implemented by organizations in a shared manner, in whole or in part, without unnecessary duplication or the imposition of conflicting requirements.
修改后标准和ISO 14001：2004的兼容性已经维护而且有所提高。“兼容性”的意思是组织对这两份标准的共同条款可以从整体上，或者部分地采用分享的方式来执行，没有必要重复进行，要不然，这些要求会发现相互矛盾的现象。59. Are there any guidelines covering joint implementation of ISO 9001 and ISO 14001?
如何整合执行ISO 9001和ISO 14001是否有什么指南？
The two standards are compatible. It is not expected that an ISO guideline will be prepared on this subject at the present time. If the need for such a document arises, ISO will consider the request as a new project. However, both ISO 9001 and ISO 14001 include an annex to show the correspondence between the two standards.
这两份标准是可以兼容的。不要期望ISO 9001最近会颁布这方面的指导文章。如果的确需要的话，ISO会考虑这个要求，作为一个新的专题项目。不过，这两份标准的后面都有附录，告诉您条款的对应关系。67. My organisation fulfils the ISO 9001:2000 requirements. What do I need to do?
我们组织满足了ISO9001：2000标准的要求。我们应当如何做？An organization who’s QMS fulfils the requirements of ISO 9001:2000 should check that they are following the clarifications introduced in the amended standard ISO 9001:2008.
某组织的质量管理体系满足了ISO9001：2000标准的各项要求应当检查一下，他们是否符合ISO 9001：2008标准中增加的一些解释。ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000. It does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
ISO 9001：2008是为了对现在的ISO9001：2000标准介绍一些解释而开发编写的（译者注：2008年11月15日已经公布了）。ISO9001：2008没有增加新的要求，也没有改变ISO9001：2000标准的意向用途。
