ISO9001：2000中英文对照
Quality management systems — Requirements
质量管理体系——要求
1 Scope
1 范围
1.1 General
1.1 总则
This International Standard specifies requirements for a quality management system where an organization
本标准为有下列需求的组织规定了质量管理体系要求：
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
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) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
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，旨在增进顾客满意。
NOTE In this International Standard, the term “product”applies only to the product intended for, or required by, a customer.
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 Application
1.2 应用
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本标准规定的所有要求是通用的，旨在适用于各种类型、不同规模和提供不同产品的组织。
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
当本标准的任何要求由于组织及其产品的特点不适用时，可以考虑对其进行删减。
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
除非删减仅限于本标准第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 Normative reference
2 引用标准
The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based 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 Standards.
下列标准所包含的条文通过在本标准中引用而构成本标准的条文。本标准出版时，新示版本均为有效。所有标准都会被修订，使用本标准的各方探讨使用下列标准最新版本的可能性。
ISO 9000:2000, Quality management systems —Fundamentals and vocabulary.
ISO9001:2000质量管理体系——基础和术语
3 Terms and definitions
3 术语和定义
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
include中文本标准采用ISO9000中的术语和定义。
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
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：
supplier organization customer
供方——组织——顾客
The term “organization”replaces the term “supplier”used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier”now replaces the term “subcontractor”.
本标准中的术语“组织”用以取代ISO9001：1994所使用的术语“供方”，术语“供方”用以取代术语“分承包方”。
Throughout the text of this International Standard, wherever the term “product”occurs, it can also mean “service”.
本标准中所出现的术语“产品”，也可指“服务”。
4 Quality management system
4 质量管理体系
4.1 General requirements
4.1 总要求
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.
组织应按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。
The organization shall
组织应：
a) identify the processes needed for the quality management system and their application throughout t
he organization (see 1.2),
a) 识别质量管理体系所需的过程及其在组织中应用（见1.2）
b) determine the sequence and interaction of these processes,
b) 确定这些过程的顺序和相互作用；
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
c) 确定为确保这些过程的有效运作和控制所需的准则和方法；
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
d) 确保可以获得必要的资源和信息，以支持这些过程的运作和监视；
e) monitor, measure and analyse these processes, and
e) 监视、测量和分析这些过程；
f) implement actions necessary to achieve planned results and continual improvement of these processes.
f) 实施必要的措施，以实现对这些过程所策划的结果和对这些过程的持续改进。
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
组织应按本标准的要求管理这些过程。
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
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加以识别。
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
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 Documentation requirements
4.2 文件要求
4.2.1 General
4.2.1 总则
The quality management system documentation shall include
质量管理体系文件应包括：
a) documented statements of a quality policy and quality objectives,
a) 形成文件的质量方针和质量目标；
b) a quality manual,
b) 质量手册；
c) documented procedures required by this International Standard,
c) 本标准所要求的形成文件的程序；
d) documents needed by the organization to ensure the effective planning, operation and control of its processes,and
d) 组织为确保其过程有效策划、运作和控制所需的文件；
e) records required by this International Standard (see 4.2.4).
e) 本标准所要求的记录（见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.
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。
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
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：
a) the size of organization and type of activities,
a) 组织的规模和活动的类型；
b) the complexity of processes and their interactions, and
b) 过程及其相互作用的复杂程度；
c) the competence of personnel.
c) 人员的能力。
NOTE 3 The documentation can be in any form or type of medium.
3、文件可采用任何形式或类型的媒体
4.2.2 Quality manual
4.2.2 质量手册
The organization shall establish and maintain a quality manual that includes
组织应编制和保持质量手册，质量手册包括：
a) the scope of the quality management system, including details of and justification for any exclusions (see
1.2),
a) 质量管理体系的范围，包括任何删减的细节与合理性（见1.2）；
b) the documented procedures established for the quality management system, or reference to them, and
b) 为质量管理体系编制的形成文件的程序或对其引用
c) a description of the interaction between the processes of the quality management system.
c) 质量管理体系过程之间的相互作用的表述
4.2.3 Control of documents
4.2.3 文件控制
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
质量管理体系所要求的文件应予以控制。记录是一种特殊类型的文件，应依据4.2.4的要求进行控制。
A documented procedure shall be established to define the controls needed:
应编制形成文件的程序，以规定以下方面所需的控制：
a) to approve documents for adequacy prior to issue,
a) 文件发布前得到批准，以确保文件是充分与适宜的
b) to review and update as necessary and re-approve documents,
b) 必要时对文件进行评审与更新，并再次批准；
c) to ensure that changes and the current revision status of documents are identified,
c) 确保文件的更改和现行修订状态得到识别；
d) to ensure that relevant versions of applicable documents are available at points of use,
d) 确保在使用处可获得有关版本的适用文件
e) to ensure that documents remain legible and readily identifiable,
e) 确保文件保持清晰、易于识别；
f) to ensure that documents of external origin are identified and their distribution controlled, and
f) 确保外来文件得到识别，并控制其分发；
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
g) 防止作废文件的非预期使用，若因任何原因而保留作废文件时，对这些文件进行适当的标识。
4.2.4 Control of records
4.2.4记录的控制
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
应建立并保持记录，以提供符合要求和质量管理体系有效运行的证据。记录应保持清晰、易于识别和检索。应编制形成文件的程序，以规定记录的标识、贮存、保护、检索、保存期限和处置所需的控制。
5 Management responsibility
5 管理职责
5.1 Management commitment
5.1 管理承诺
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
最高管理者应通过以下活动，对其建立、实施质量管理体系并持续改进其有效性的承诺提供证据：
a) communicating to the organization the importance of meeting customer as well as statutory and
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