iso9001认证质量管理体系基础
Certification of quality management system based on ISO9001
在ISO9001：2008版标准中，列出了12条质量管理体系基础，这是理解ISO9000族标准的基础知识，也是质量管理原则在质量管理体系中的表现，并为ISO9001和ISO9004条款制定规定了框架。
In ISO9001: 2008 edition standard, lists 12 quality management system, this is the understanding of ISO9000 standards of basic knowledge, but also the quality management principle in the quality management system performance, and for ISO9001 and ISO9004 clauses set frame.
1、质量管理体系理论说明（逻辑依据）
1, quality management system theory ( logic )
质量管理体系能够帮助组织增进顾客满意。
Quality management systems can help organizations to enhance customer satisfaction.
质量管理体系方法鼓励组织分析顾客要求，规定相关的过程，并使其持续受控，以实现顾客能接受的产品。
Quality management system method to encourage organizations to analyse customer requirements, define the processes, and to continuously controlled, to achieve customer to accept products.
2、质量管理体系要求与产品要求
In 2, the requirements of quality management system and product requirements
两类不同的要求，质量管理体系要求是通用的，是实施质量管理体系的能力要求，适用于所有行业、任何类型的产品；产品要求是产品特性的要求；不是通用的，具有很强的针对性。质量管理体系要求是对产品要求的补充。
Two kinds of different requirements, the requirements of quality management system is universal, is to implement the quality management system requirements, applicable to all industries, all types of products; product requirements of product specifications; not general, have very strong specific aim. Requirements for quality management systems are complementary to requirements for products.
3、质量管理体系方法
3, the quality management system approach
建立和实施质量管理体系的方法包括了八个步骤，这是“管理的系统方法”在质量管理体系的应用，也体现了PDCA方法的运用。
The establishment and implementation of the quality management system of the method comprises eight steps, this is" system approach to management" in the application of quality management system, but also reflects the PDCA method application.
4、过程方法
4, process method
当质量管理原则中的过程方法在质量管理体系中应用时，为使组织有效运行，必须识别和管理许多相互作用的过程，系统的识别和管理组织所使用过程，特别是这些过程之间的相互作用，称为：“过程方法”。本标准鼓励采用过程方法管理体系，并形成了基于过程的质量管理体系模式。
When the principle of quality management of the process method in quality management system applications, for organizations to function effectively, it has to identify and manage many interacting processes, system identification and management of organization process, particularly the interactions between these processes, called:" process approach". This standard is to encourage the adoption of process management system, and the formation of the quality management system based on process model.
5、质量方针和质量目标
5, the quality policy and quality objectives
表达质量方针和质量目标的作用，还说明了两者的关系。
Expression of the quality policy and quality objectives, also illustrates the relationship between the two.
6、最高管理者在质量管理体系中的作用
6, top management the effect in quality management system
是领导作用原则在质量管理体系中的具体化要求。
Is the leading role of principle in the quality management system of specific requirements.
7、文件
7, file
文件的作用是沟通意图，统一行动。文件的形成并不是目的，它应是项增值活动。质量管理体系中使用的文件类型有：质量手册、质量计划、规范、指南、程序、作业指导书、图样和记录。
File is the role of communication of intent, unified action. File formation is not a purpose, it should be value-added activities. Quality management system used in the file types are: quality manual, quality plans, specifications, guidelines, procedures, work instructions, drawings and records.
8、质量管理体系评价
8, quality management system assessment
评价质量管理体系时，应对每个被评价的过程，提出四个基本问题：
Evaluation of the quality management system, with each being evaluation process, puts forward four basic problems:
A、 过程是否已被识别并适当规定？
A, process identified and appropriately defined?
B、 职责是否已被分配？
B, responsibility has been assigned?
C、 程序是否得到实施和保持？
C, whether the program is implemented and maintained?
D、 在实现所要求的结果方面，过程是否有效？
D, in achieving the required results, whether the process is effective?
综合回答上述问题可以确定评价结果。
Comprehensive answer these questions can determine the result of the evaluation.
质量管理体系评价方法包括：质量管理体系审核、管理评审、自我评审（此项只适用于ISO9004：2000）。
Quality management system assessment method including: quality management system audit, management review, self assessment ( this only applies to ISO9004: 2000 ).