深入了解iso9000：2008族的标准内容及其使用指南
A thorough understanding of ISO9000: 2008 family standards and guidelines for their use
ISO9000族标准是国际标准化组织(英文缩写为ISO)于1987年制订，后经不断修改完善而成的系列标准。现已有90多个国家和地区将此标准等同转化为国家标准。我国等同采用ISO9000族标准的国家标准足GB/T19000族标准。
ISO9000 International Organization for Standardization ( English abbreviation ISO ) enacted in 1987, after the continuous modification and perfection of a series of standards. Now has more than 90 countries and regions will be the standard equivalent transformation for national standard. Our equivalent ISO9000 standard national standard GB / T19000 family of standards.
  一般地讲组织活动由三方面组成：经营、管理和开发。在管理上又主要表现为行政管理、财务管理、质量管理等。
Generally speaking activities organization composed of three aspects: business, management and development. Management and mainly for administrative management, financial management, quality management.
  ISO9000族标准主要针对质管理，同时涵盖了部分行政管理和财务管理的范畴。
ISO9000 standards for quality management, at the same time covers part of the administrative management and financial management category.
  ISO9000族标准并不是产品的技术标准，而是针对组织的管理结构、人员、技术能力、各项规章制度、技术文件和内部监督机制等一系列体现组织保证产品及服务质量的管理措施的标准。
The ISO9000 standard is the technical standard of the product, but to the organizational management structure, personnel, technology skills, rules and regulations, technical documentation and internal monitoring mechanism and a series of organization and guarantee the quality of products and services management measures.
  具体地讲ISO9000族标准就是在以下四个方面规范质量管理：
Specifically, ISO9000 standard is in the following four aspects of quality management:
  1、机构：标准明确规定了为保证产品质量而必须建立的管理机构及职责权限。
1, institutions: standard specified in order to ensure product quality and must establish the management mechanism and the responsibility limits of authority.
  2、程序：组织的产品生产必须制定规章制度、技术标准、质量手册、质量体系操作检查程序，并使之文件化。
2: the organization, procedure product production must formulate rules and regulations, technical standards, quality manual, quality system operation inspection procedures, and documentation.
  3、过程：质量控制是对生产的全部过程加以控制，是面的控制，不是点的控制。从根据市场调研确定产品、设计产品、采购原材料，到生产、检验、包装和储运等，其全过程按程序要求控制质量。并要求过程具有标识性、监督性、可追溯性。
3: quality control, process is the production of the whole process to control, the control is, not to the point of control. According to market research to determine, from product design, product procurement of raw materials, production, testing, packaging and storage and transportation, the whole process of quality control according to the program requirements. Process and requirements with identification, surveillance, traceability.
  4、总结：不断地总结、评价质量管理体系，不断地改进质量管理体系，使质量管理呈螺旋式上升。
Summary: 4, constantly sum up, evaluation of the quality management system, continuous improvement of quality management system, quality management spiral.
  通俗地讲就是把组织的质量管理标准化，而标准化上质量管理生产的产品及其服务，其质量是可以信赖的。
Common ground is told is the organization's quality management standardization, and the standardization of quality management products and services, the quality is reliable.
  ISO9000族标准的推行，与我国实行的现代企业改革具有十分强烈的相关性。两者都是从制度上、体制上、管理上入手改革，不同点在于前者处理组织的微观环境，后者侧重于组织的宏观环境。由此可见，ISO9000族标准非常适宜我国国情。因此，国家明文规定“九五”期间全面推行ISO9000族标准。
ISO9000 standards are introduced, and the implementation of China 's modern enterprise reform has very strong correlation. Both are from the system, management system, reform, the difference lies in that the former processing tissue microenvironment, which focused on the organization of the macro environment. Thus, ISO9000 standard is very suitable for the national conditions of our country. Therefore, the state expressly" Nine Five " during the full implementation of ISO9000 standards.
  ISO9000族标准认证，也可以理解为质量管理体系注册，就是由国家批准的、公正的第三方机构——认证机构，依据ISO9000族标准，对组织的质量管理体系实施评介，向公众证明该组织的质量管体系符合ISO9000族标准，提供合格产品，公众可以相信该组织的服务承诺和组织的产品质量的一致性。
ISO9000 standard certification, can also be understood as quality management system registration, is approved by the state, an impartial third party institutions -- certification body, according to the ISO9000 standard, the organization's quality management system implementation review, to the public that the organization's quality management system in accordance with ISO9000 standards, to provide qualified products, the public can believe the organization's commitment to service and product quality consistency.
  1SO9000族标准不仅在全部发达国家推行，发展中国家也正在逐步加入到此行列中来，ISO已成为—个名副其实的技术上的世界联盟，造成这种状况的原因，除上述它能给组织带来的巨大的实际利益之外，更为深刻的原因在于ISO9000族标准是人类文明发展过程中的必然之物。
1SO9000 standard not only in all developed countries, developing countries also are gradually added to the ranks, ISO has become a be worthy of the name of the technology world alliance, the reasons for this situation, in addition to the above it can be brought to the organization of huge practical interests, a more profound reason lies in ISO9000 standard is human the process of civilization development inevitable.
  因此，在一个组织或一个国家实行ISO9000族标准并非是一个外部命令，而是现代组织的本质要求。
Therefore, in a tissue or a country to execute ISO9000 standard is not an external command, but the essential requirement of modern organization.
  2000版IS09000标准介绍
The 2000 edition of the IS09000 standard introduction
  国际标准化组织(英文缩写为ISO)对9000族系列标准进行“有限修改”后，于1994年正式颁布实施IS09000族系列标准，即94版。在广泛征求意见的基础上，又启动了修订战略的第二阶段，即“彻底修改”。1999年11月提出了2000版ISO／DIS9000、ISO／DIS9001和ISO／DIS9004国际标准草案。此草案经充分讨论并修改后，于2000年12月15日正式发布实施。ISO规定自正式发布之日起三年内，94版标准和2000版标准将同步执行，同时鼓励需要认证的组织，从2001年开始可按2000版申请认证。
International Organization for Standardization ( English abbreviation ISO ) on 9000 series standards are" limited modification", in 1994 formally promulgated and implemented IS09000 series standard, namely, 94 edition. In the extensive solicitation of opinions on the basis of, and launched the revised strategies in the second stage, namely" thoroughly revised". In 1999 November 2000 edition presents the ISO / DIS9000, ISO / DIS9001 and ISO / DIS9004 draft international standard. This draft after full discussion and revision, in December 15, 2000 formally promulgated and implemented. ISO requirement from the official release date of three years, 94 version of the standard and 2000 edition standard will be executed, at the same time the need to encourage the certification organization, from the beginning of 2001 according to the 2000 edition certification.
  2000版标准总体变化如下：
The 2000 version of the standard overall changes as follows:
  一、由四个标准组成：
One, by four standard:
  1、ISO9000作为选用标准，同时也是名词术语标准，即94版ISO9000-1标准与ISO8402的结合。
In 1, ISO9000 as the selection standard, but also the standard nomenclature, namely the 94 edition of the ISO9000-1 standard and ISO8402 combination.
  2、ISO9001标准代替94版三个质量保证模式，例如94版ISO9002标准获证的组织在复审时，允许对2000版IS09001标准进行删剪。
In 2, ISO9001 instead of standard 94 edition three quality assurance model, such as the 94 edition of the ISO9002 standard certification organization in review, allow for the 2000 version of IS09001 standards for pruning.
  3、ISO9004标准代替94版IS09004-1多项分标准。
In 3, ISO9004 instead of Standard Version 94 IS09004-1 number of standard.
  4、ISO／CD．1 19011标准代替94版ISO10011标准和94版环境ISO14010、ISO14011、ISO14012。
In 4, ISO / CD.1 19011 standard to replace the 94 version of ISO10011 standard and the 94 edition of ISO14010, ISO14011, ISO14012.
  二、IS09001标准的主要变化如下：
In two, the standard IS09001 main changes were as follows:
  (一)思路和结构上的变化
( a ) and the train of thought of structural change
  1、把过去三个外部保证模式ISO9001、ISO9002、ISO9003合并为ISO9001标准，允许通过裁剪适用不同类型的组织，同时对裁剪也提出了明确严格的要求。
In 1, the last three external assurance model ISO9001, ISO9002, ISO9003 and ISO9001 standard, allowing through cutting for different types of organizations, at the same time the cutting also put forward a clear strict requirements.
  2、把过去按20个要素排列，改为按过程模式重新组建结构，其标准分为管理职责；资源管理；产品实现；测量、分析和改进四大部分。
In the past 2, according to the 20 elements are arranged, is changed according to the process of reorganization of structure mode, the standard is divided into management; resource management; product realization; measurement, analysis and improvement of four parts.
  3、引入PDCA戴明环闭环管理模式，使持续改进的思想贯穿整个标准，要求质量管理体系及各个部分都按PDCA循环，建立实施持续改进结构。
In 3, the introduction of PDCA Dai Minghuan closed management mode, so that the idea of continuous improvement throughout the standard requirements and quality management system, each part according to PDCA cycle, establishing and implementing continuous improvement structure.
  4、适应组织管理—体化的需要。
4, adaptive organization management integration needs.
  (二)新增加的内容
( two) the newly added content
  1、以顾客为关注焦点；
1, customer focus;
  2、持续改进；
2, continuous improvement;
  3、质量方针与目标要细化、要分解落实；
3, quality policy and quality objectives should be refined, to decompose fulfil;
  4、强化了最高管理者的管理职责；
4, strengthen the top management responsibilities;
  5、增加了内外沟通；
5, increase of internal and external communication;
  6、增加了数据分析；
In 6, an increase of data analysis;
  7、强化了过程的测量与监控。
7, strengthen the process of measuring and monitoring.
  三、特点：
In three, features:
  1、通用性强,94版ISO9001标准主要针对硬件制造业，新标准还同时适用于硬件、软件、流程性材料和服务等行业，
1, strong versatility, the 94 edition of the ISO9001 standard for hardware manufacturing industry, the new standard also applies to both hardware, software, flow of material and service industries,
  2、更先进、更科学，总结补充了组织质量管理中一些好的经验，突出了八项质量管理原则。
2, more advanced, more scientific, summarize supplement organization quality management in some good experience, highlight the eight quality management principles.
  3、对94版标准进行简化，简单好用。
In 3, the 94 version of the standard was simplified, easy to use.
  4、提高了同其它管理的相容性，例如同环境管理、财务管理的兼容。
4, improve the compatibility with other management, such as environmental management, financial management of compatible.
  5、ISO9001标准和IS09004标准作为一套标准，互相对应，协凋一致。
In 5, ISO9001 and IS09004 standards as a set of standards, corresponding to each other, assist wither consistent.
  组织通过ISO9000质量管理体系认证的意义：
Tissue through the ISO9000 quality management system certification significance:
  1．可以完善组织内部管理，使质量管理制度化、体系化和法制化，提高产品质量，并确保产品质量的稳定性；
1 can improve the internal management, the quality management system, system and legal system, improve product quality, and ensure the stability of product quality;
  2．表明尊重消费者权益和对社会负责，增强消费者的信赖，使消费者放心，从而放心地采用其生产的产品，提高产品的市场竞争力，并可借此机会树立组织的形象，提高组织的知名度，形成名牌企业；
2 showed respect for the rights and interests of consumers and responsible to society, strengthening the trust of consumers, so that consumers be assured, so rest assured use of their products, improve the market competitiveness of products, and can take the opportunity to establish the image of the tissue, enhancing the organization's visibility, form famous brand enterprise;
  3．ISO9000质量管理体系认证有利于发展外向型经济，扩大市场占有率，是政府采购等招投标项目的入场券，是组织向海外市场进军的准入证，是消除贸易壁垒的强有力的武器；
The 3.ISO9000 quality management system certification is conducive to the development of export-oriented economy, expand market share, is the government procurement bidding project admission ticket, is the organization to overseas market access permits the elimination of trade barriers, is a powerful weapon;
  4．通过ISO9000质量管理体系的建立，可以举一反三地建立健全其它管理制度；
In 4 through the ISO9000 quality management system are established, can infer other things from one fact to establish and perfect the management system;
  5．通过ISO9000认证可以—举数得，非一般广告投资、策划投资、管理投资或培训可比，具有综合效益；还可享受国家的优惠政策及对获证单位的重点扶持。
5 through the ISO9000 certification can - to name a few, not general advertising investment, investment, investment planning management or training comparable, with comprehensive benefits; can also enjoy the preferential policies of the state and the certification unit to support the focus.