Quality management systems –Requirements
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including process for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. NOTE In this International Standard, the term “product” applies only to the product intended for, or required by ,a customer.
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size ad product provided.
Where any requirements(s) of this International Standard cannot be applied 质量管理体系– 要求
1 范围
1.1总则
本标准为有下列需求的组织规定了质量管理体系要求：
a) 需要证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品；
b) 通过体系的有效应用，包括体系持续改进的过程以及保证符合顾客与适用的法律法规要求，旨在增强顾客满意。
注：在本标准中，术语“产品”仅适用于预期提供给顾客或顾客所要求的产品。
1.2 应用
本标准规定的所有要求都是通用的，旨在适用于各种类型、不同规模和提供不同产品的组织。
当本标准的任何要求因组织及其产品的特点而不适用时，可以考虑对其进行删减。。
due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless the exclusions are limited to requirements within clau 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subquent amendments to, or revisions of, any of the publications do not apply. However, parties to agreements bad on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International 除非删减仅限于第7章中那些不影响组织提供满足顾客和适用法律法规要求的产品的能力或责任的要求，否则不能声称符合本标准。
2 .引用标准
下列标准所包含的条文，通过在本标准中的引用而构成本标准的条文。本标准出版时，所示版本均为
有效。所有标准都会被修订，使用本标准的各方应探讨使用下列标准最新版本的可能性。
Standards.
ISO 9000:2000, Quality management systems – Fundamentals and vocabulary.
3 Terms
For the purpos of this International Standard, the terms and definitions given in ISO 9000 apply.
The following terms, ud in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently ud:
supplier à organization à customer
The term “organization” replaces the term “supplier” ud in ISO 9001:1994, and refers to the unit to which the International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “rvice”.
4 Quality management system
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and GB/T 19000-2000 质量管理体系－基础和术语（idt ISO9000:2000）。
3.术语和定义
本标准采用GB/T 19000中的术语和定义。
本标准描述供应链所使用的以下术语经过了更改，以反映当前的使用情况：
供方à组织à顾客
本标准中的术语“组织”用以取代GB/T 19001-1994所使用的术语“供方”，术语“供方”用以取代术语“分承包方”。本标准中所出现的术语“产品”，也可指“服务”。
政治民主4. 质量管理体系
4.1总要求
特别狠心特别爱
组织应依照本标准的要求建立质量管理体系，形成文件，加以实施和保持，并持续改进其有效性。
continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall延边牛
a) identify the process needed for the quality management system and their application throughout the organization (e 1.2),
b) determine the quence and interaction of the process,
c) determine criteria and methods needed to ensure that both the operation and control of the process are effective, d) ensure the availability of resources ad information necessary to support the operation and monitoring of the process,
e) monitor, measure and analy the process, and
f) implement actions necessary to achieve planned results and continual improvement of the process.
The process shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization choos to outsource any process that affects product conformity with requirements, the organization shall ensure control over such process. Control of such 组织应：
a) 识别质量管理体系所需的过程及其在组织中的应用（见
1.2）；
b) 确定这些过程的顺序和相互作用；
c) 确定为确保这些过程有效运作和控制所需的准则和方法；
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对这些过程的监视；
e) 监视、测量和分析这些过程；
f) 实施必要的措施，以实现对这些过程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。
六级口语
针对组织所选择的任何影响产品符合要求的外包过程，组织应确保对其实施控制。对此类外包过程的控制应在质量管理体系中加以识别。
outsourced process shall be identified within the quality management system.
NOTE Process needed for the quality management system referred to above should include process for management activities, provision of resources, product realization and measurement.
4.2 Documentation requirements
4.2.1 General
走投无路的意思The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of it
s process, and
e) records required by this International Standard (e 4.2.4)
NOTE 1 Where the term “documented procedure ” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.腌羊肉的腌制方法
NOTE2 The extent of the quality management system documentation can 注：上述质量管理体系所需的过程应当包括与管理活动、资源提供、产品实现和测量有关的过程。
4.2 文件要求
4.2.1总则
质量管理体系文件应该包括：
a) 形成文件的质量方针和质量目标；
b) 质量手册；
相思古诗王维c）本标准所要求的形成文件的程序；
小学语文教学案例d) 组织为确保其过程的有效策划、运作和控制所需的文件；e）本标准所要求的记录。(见4.2.4)
注：（1）本标准出现“形成文件的程序”之处，即要求建立该程序，形成文件，并加以实施和保持。
（2）不同组织的质量管理体系文件的多少与详略程度取决于：
