序言这是Plus 9001的第五版，这是一本实施IS0 9001系列标准的实用手册。本版本基于ISO 9001:2015。本手册的主要目的是为新手和经验丰富的质量从业者提供一个简明、用户友好的指南，以了解和实施ISO 9001质量管理标准的要求。ISO 9000系列标准自1987年首次发布以来，经历了四次修订。ISO 9001在1994年、2000年、2008年进行了修订，最近一次是在2015年。 手册的第一部分由四个小节组成:“引言”；“过程方法”；“概念概述”；以及“实施路径”。“引言”概述了ISO 9000系列标准的背景。“过程方法”介绍了ISO质量管理体系中的一些基本概念。“概念概述”提供了对与质量管理体系（QMS）相关的基础知识的理解。最后，“实施路径”提出了质量管理体系注册的方法，并描述了第三方进行合格评定的过程- 缔约方登记机构（登记员）和认证机构。手册的第二部分也由小节组成，这些小节根据ISO 9001:2015中相应的条款编号进行编号。其中包括:-ISO 9001:2015的实际文本；-指南，解释ISO 9001:2015标准的意图；-摘自ISO 9000:2015的众多定义对寻求实施基于ISO 9001:2015的QMS的组织有用的典型审核问题；和——组织在准备质量管理体系时使用的自我诊断问题。 引言。1概述ISO 9000系列标准的制定是为了帮助各种类型和规模的组织实施和运行有效的质量管理体系（QMS）。它包括四个核心标准:a）ISO 9000:2015，质量管理体系-基础和词汇，描述了QMS的基础，并规定了ISO 9000系列中所有标准的术语。b） ISO 9001:2015《质量管理体系——要求》规定了质量管理体系的要求，其中组织需要证明其能够始终如一地提供满足客户和适用法律法规要求的产品和服务，并旨在提高客户满意度。 c） ISO 9004:2009《为组织的持续成功而管理——一种质量管理方法》在满足所有相关方的需求和期望方面，提供了比ISO 9001更广泛的质量管理重点，并为系统和持续改进组织的整体绩效和实现持续成功提供了指导。ISO 9004目前正在修订中，预计将于2018年初发布。d） ISO 19011:2011《管理体系审核指南》提供了审核任何ISO管理体系（质量、环境、职业健康安全等）的指南。 )，关于审计计划的管理，关于管理体系审计的规划和实施，以及关于审计员和审计团队的能力和评估。0.2质量管理体系的基本原理质量管理体系帮助组织提高客户满意度。客户需要满足其需求和期望的产品和服务。这些在产品和服务规范中表达的需求和期望统称为“客户需求”。客户要求可以由客户以合同形式指定，也可以由组织根据市场调查自行确定。 在这两种情况下，客户最终决定产品或服务的可接受性。由于客户的需求和期望往往会随着时间的推移而变化，因此组织需要不断改进其产品、服务和流程，因为过去提供客户满意度的功能/功能可能会成为未来客户不满的来源。QMS方法鼓励组织分析客户需求，定义必要的过程，以帮助开发满足规定要求的产品和服务，并保持这些过程处于受控状态。 质量管理体系可以提供改进框架，以提高客户和其他相关方的满意度。它提供了满足需求的信心。0.3 ISO 9000标准的增长多年来，ISO 9000系列标准的应用已大大扩展。ISO 9001已成功取代世界各地质量保证领域的国家标准。尽管近年来增长率趋于平稳，但国际标准化组织（ISO）进行的最新调查显示，201个国家已经颁发了100多万张证书。 这两个数字清楚地表明了标准的广泛接受和使用。证书只是ISO系列标准向用户提供的价值的一个指标，因为许多组织在没有寻求认证的情况下实施了ISO 9001。此外，越来越多的行业特定标准为ISO 9001的应用提供指导，以满足行业或商业部门的特殊要求。1过程方法（概述）ISO 9001在开发、实施和改进QMS的有效性时，促进采用过程方法，从而通过满足客户要求来提高客户满意度。 一个组织要有效运作，就必须识别和管理大量相关的任务和活动。任务和活动使用资源，并进行管理，以便将输入转化为输出，这可以被视为一个过程。通常，一个进程的输出直接构成下一个进程的输入。图1“具有PDCA循环的QMS模型”说明了控制系统内任何过程的预期结果的方法。在一个组织内应用一个过程系统，以及这些过程及其管理的识别和交互，可以称为“过程方法”。 过程方法的一个优点是，它提供了对过程系统中各个过程之间的联系以及它们的组合和交互的持续控制。在质量管理体系中使用时，这种方法强调了以下重要性:-理解和满足要求；-需要考虑附加价值的过程；获得过程绩效和有效性的结果；以及——基于客观测量的流程改进。过程模型- 图1所示的基于质量管理体系说明了ISO 9001:2015第4条至第10条所述的过程联系。该图显示，客户和相关利益方在将需求定义为输入方面发挥着重要作用。监控客户满意度需要持续评估与客户相关的信息？顾客对组织是否满足顾客要求的看法。图1所示的模型涵盖了ISO 9001:2015的所有要求，但在较高的层次上显示了系统，而不是在详细的过程层次上。 此外，Walter Shewart首先确定的方法，即“计划-执行-检查-行动”（PDCA），可以应用于所有过程。PDCA可以简单地描述为:计划:根据客户和相关利益方的要求，建立交付结果所需的目标和过程，以及组织？中国的政策。执行:执行流程。检查:对照产品和服务的政策、目标、目的和要求，监控和测量过程、产品和服务，并报告结果。 行动:采取行动改善流程绩效。该模型用于构建ISO 9001标准，如图2所示。由于该模型与所有七项质量管理原则（QMP）相关联，这些QMP的影响在ISO 9001的内容中可见，在ISO 9004中更是如此。ISO 9001:2015第0.3条对过程方法进行了进一步阐述。

PrefaceThis is the fifth edition of Plus 9001, A practical handbook for implementing the IS0 9001 family of standards. This edition is based on ISO 9001:2015. The primary objective of this handbook is to provide both novice and experienced quality practitioners with a concise, user-friendly guide to understanding and implementing the requirements of the ISO 9001 quality management standard. The ISO 9000 series of standards has undergone four revisions since it was initially published in 1987. ISO 9001 was revised in 1994, 2000, 2008, and, most recently, in 2015. The first part of the handbook is made up of four subsections: "Introduction"; "The process approach"; "Conceptual overview"; and "An implementation path". The "Introduction" outlines the background of the ISO 9000 series of standards. "The process approach" introduces some of the basic concepts found in the ISO quality management system. "Conceptual overview" provides an understanding of the fundamentals associated with quality management systems (QMSs). Finally, "An implementation path" suggests an approach for QMS registration, and describes the process of conformity assessment by third-party registration bodies (registrars) and accreditation bodies. The second part of the handbook is also made up of subsections, which are numbered according to corresponding clause numbers in ISO 9001:2015. These contain: - the actual text of ISO 9001:2015; - guidance, providing an explanation of the intent of the ISO 9001:2015 standard; - numerous definitions extracted from ISO 9000:2015; - typical audit questions useful for organizations seeking to implement a QMS based on ISO 9001:2015; and - self-diagnostic questions to be used by an organization while preparing its quality management system.Introduction0.1 General The ISO 9000 series of standards was developed to assist organizations of all types and sizes to implement and operate an effective quality management system (QMS). It consists of four core standards: a) ISO 9000:2015, Quality management systems - Fundamentals and vocabulary, describes the fundamentals of a QMS and specifies the terminology for all standards within the ISO 9000 series. b) ISO 9001:2015, Quality management systems - Requirements, specifies requirements for a QMS, where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction. c) ISO 9004:2009, Managing for the sustained success of an organization - A quality management approach, provides a wider focus on quality management than ISO 9001 in addressing the needs and expectations of all relevant interested parties, and provides guidance for the systematic and continual improvement of the organization's overall performance and achievement of sustained success. ISO 9004 is currently being revised, with the expectation of being published in early 2018. d) ISO 19011:2011, Guidelines for auditing management systems, provides guidance on auditing any ISO management system (quality, environmental, occupational health and safety, etc.), on the management of an audit programme, on the planning and conducting of an audit of the management system, as well as on the competence and evaluation of an auditor and an audit team. 0.2 Rationale for a QMS A QMS assists an organization in enhancing customer satisfaction. Customers require products and services with characteristics that satisfy their needs and expectations. These needs and expectations, expressed in product and service specifications, are collectively referred to as "customer requirements". Customer requirements may be specified contractually by the customer, or may be determined by the organization itself, based on market research. In either case, the customer ultimately determines the acceptability of the product or service. Because customer needs and expectations tend to change over time, organizations are driven to continually improve their products, services and processes, since a feature/function that provided customer satisfaction in the past may be a source of customer dissatisfaction in the future. The QMS approach encourages organizations to analyze customer requirements, define the necessary processes to contribute to development of products and services that meet the specified requirements, and to maintain those processes under control. A QMS can provide the framework for improvements to enhance the satisfaction of customers and other interested parties. It provides confidence, to the requirements. 0.3 Growth of ISO 9000 standards The application of the ISO 9000 series of standards has expanded considerably over the years. ISO 9001 has successfully replaced national standards in the field of quality assurance around the world. Although the growth rate has levelled off in recent years, the latest survey conducted by ISO indicates that more than one million certificates have been issued in 201 countries. Both numbers clearly indicate the widespread acceptance and usage of the standards. Certificates are only one indicator of the value that the ISO series of standards provides to its users, as many organizations have implemented ISO 9001 without seeking certification. In addition, there are a growing number of sector-specific standards that provide guidance on the application of ISO 9001 in meeting the particular requirements of an industry or business sector. 1 The process approach (overview) ISO 9001 promotes the adoption of the process approach when developing, implementing, and improving the effectiveness of a QMS, so as to enhance customer satisfaction, by fulfilling customer requirements. For an organization to function effectively, it has to identify and manage numerous linked tasks and activities. Tasks and activities use resources, and are managed in order to enable the transformation of inputs into outputs, which can be considered to be a process. Often, the output from one process directly forms the input to the next process. Figure 1, "QMS Model with PDCA cycle", illustrates an approach for controlling the expected results from any process within the system. The application of a system of processes within an organization, together with the identification and interaction of these processes and their management, can be referred to as the "process approach". An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within a QMS, such an approach emphasizes the importance of: - understanding and fulfilling requirements; - the need to consider processes in terms of added value; - obtaining results of process performance and effectiveness; and - improvement of processes based on objective measurement. The model of a process-based QMS shown in Figure 1 illustrates the process linkages described in Clauses 4 to 10 of ISO 9001:2015. This illustration shows that customers and relevant interested parties play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the ongoing evaluation of information relating to the customer?s perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of ISO 9001:2015, but shows the system at a high level, not at the detailed process level. In addition, the methodology first identified by Walter Shewart, known as "Plan-Do-Check-Act" (PDCA), can be applied to all processes. PDCA can be briefly described as: Plan: establish the objectives and processes necessary to deliver results in accordance with customer and relevant-interested-party requirements, and the organization?s policies. Do: implement the processes. Check: monitor and measure processes, products, and services against policies, goals, objectives, and requirements for the products and services, and report the results. Act: take actions to improve process performance. This model was used to structure the ISO 9001 Standard, as can be seen from Figure 2. Since the model is linked to all seven quality management principles (QMPs), the influence of these QMPs is visible in the contents of ISO 9001, and even more so in ISO 9004. Further elaboration on the process approach is provided in Clause 0.3 of ISO 9001:2015.