Quality management systems — Requirements
质量管理体系——要求

1 Scope
范围

1.1  General
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。

1 Normative reference
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

2 Terms and definitions
术语和定义

For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
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”。

3  Quality management system
质量管理体系

3.1  General requirements
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 the 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。

3.2  Documentation requirements
3.2  文件要求

3.2.1 General
3.2.1 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

3.2.2 Quality manual
3.2.2 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

3.2.3 Control of documents
3.2.3 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。

3.2.4 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。

4   Management responsibility
4  管理职责

4.1 Management commitment
4.1  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 regulatory requirements,
a) 向组织传达满足顾客和法律法规要求的重要性；

b) establishing the quality policy,
b) 制定质量方针；

c) ensuring that quality objectives are established,
c) 确保质量目标的制定；

d) conducting management reviews, and
d) 进行管理评审；

e) ensuring the availability of resources.
e) 确保资源的获得。

4.2  Customer focus
4.2  以顾客为中心

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
最高管理者应以增进顾客满意为目的，确保顾客的要求得到确定并予以满足（见7.2.1和8.2.1）

4.3  Quality policy
4.3  质量方针

Top management shall ensure that the quality policy
最高管理者应确保质量方针：

a) is appropriate to the purpose of the organization,
a) 与组织的宗旨相适应；

b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
b) 包括对满足要求和持续改进质量管理体系有效性的承诺；

c) provides a framework for establishing and reviewing quality objectives,
c) 提供制定和评审质量目标的框架；

d) is communicated and understood within the organization, and
d) 在组织内得到沟通和理解；

e)  is reviewed for continuing suitability.
e) 在持续适宜性方面得到评审。

4.4  Planning
4.4  策划

4.4.1 Quality objectives
4.4.1 质量目标

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a]], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
最高管理者应确保在组织的相关职能和层次上建立质量目标，质量目标包括满足产品要求所需的内容（见7.1 a）。质量目标应是可测量的，并与质量方针保持一致。

4.4.2 Quality management system planning
4.4.2质量管理体系策划

Top management shall ensure that
最高管理者应确保：

a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
a) 对质量管理体系进行策划，以满足质量目标以及4.1的要求。

b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
b) 在对质量管理体系的变更进行策划和实施时，保持质量管理体系的完整性。

4.5  Responsibility, authority and communication
4.5  职责、权限和沟通

4.5.1 Responsibility and authority
4.5.1 职责和权限

Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.
最高管理者方确保组织内的职责、权限得到规定和沟通。

4.5.2 Management representative
4.5.2 管理者代表

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
最高管理者应指定一名管理者，无论该成员在其他方面的职责如何，应具有以下方面的职责和权限：

a) ensuring that processes needed for the quality management system are established, implemented and maintained,
a) 确保质量管理体系所需的过程得到建立、实施和保持；

b) reporting to top management on the performance of the quality management system and any need for improvement, and
b) 向最高管理者报告质量管理体系的业绩和任何改进的需求

c) ensuring the promotion of awareness of customer requirements throughout the organization.
c) 确保在整个组织内提高满足顾客要求的意识。

NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
注：管理者代表的职责可包括与质量管理体系有关事宜的外部联络。

4.5.3 Internal communication
4.5.3 内部沟通

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
最高管理者应确保在组织内建立适当的沟通过程，并确保对质量管理体系的有效性进行沟通。

4.6  Management review
4.6  管理评审

4.6.1 General
4.6.1 总则

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
最高管理者应按策划的时间间隔评审质量管理体系，以确保其持续的适宜性、充分性和有效性。评审应包括评价质量管理体系改进的机会和变更的需要，包括质量方针和质量目标。

Records from management reviews shall be maintained (see 4.2.4).
应保持管理评审的记录（见4.2.4）

4.6.2 Review input
4.6.2 评审输入

The input to management review shall include information on
管理评审的输入应包括以下方面的信息

a) results of audits,
a) 审核结果；

b) customer feedback,
b) 顾客反馈；

c) process performance and product conformity,
c) 过程的业绩和产品的符合性；

d) status of preventive and corrective actions,
d) 预防和纠正措施的状况；

e) follow-up actions from previous management reviews,
e) 以往管理评审的跟踪措施；

f) changes that could affect the quality management system, and
f) 可能影响质量管理体系的变更

g) recommendations for improvement.
g) 改进的建议。

4.6.3 Review output
4.6.3 评审输出

The output from the management review shall include any decisions and actions related to
管理评审的输出应包括以下方面有关的任何决定和措施：

a) improvement of the effectiveness of the quality management system and its processes,
a) 质量体系及其过程有效性的改进；

b) improvement of product related to customer requirements, and
b) 与顾客要求有关的产品的改进；

c) resource needs.
c) 资源需求。

5  Resource management
5 资源管理

5.1  Provision of resources
5.1  资源的提供

The organization shall determine and provide the resources needed
组织应确定并提供以下方面所需的资源：

a) to implement and maintain the quality management system and continually improve its effectiveness, and
a) 实施、保持质量管理体系并持续改进其有效性；

b) to enhance customer satisfaction by meeting customer requirements.
b) 通过满足顾客要求，增进顾客满意。

5.2  Human resources
5.2  人力资源

5.2.1 General
5.2.1 总则

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
基于适当的教育、培训、技能和经验，从事影响产品质量工作的人员应是能够胜任的。

5.2.2 Competence, awareness and training
5.2.2 能力、意识和培训

The organization shall
组织应：

a) determine the necessary competence for personnel performing work affecting product quality,
a) 确定从事影响产品质量工作的人员所必要的能力；

b) provide training or take other actions to satisfy these needs,
b) 提供培训或采取其他措施以满足这些需求；

c) evaluate the effectiveness of the actions taken,
c) 评价所采取措施的有效性；

d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
d) 确保员工认识到所从事活动的相关性和重要性，以及如何为实现质量目标作出贡献；

e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
e) 保持教育、培训、技能和经验的适当记录（见4.2.4）

5.3  Infrastructure
5.3  基础设施

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
组织应确定、提供并维护为达到产品符合要求所需的基础设施。适用时，基础设施包括：

a) buildings, workspace and associated utilities,
a) 建筑物、工作场所和相关的设施；

b) process equipment (both hardware and software), and
b) 过程设备，（硬件和软件）；

c) supporting services (such as transport or communication).
c) 支持性服务，（运输或通讯）。

5.4  Work environment
5.4  工作环境

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
组织应确定和管理为达到产品符合要求所需的工作环境。

6  Product realization
6  产品实现

6.1  Planning of product realization
6.1产品实现的策划

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
组织应策划和开发产品实现所需的过程。产品实现的策划应与质量管理体系其他过程的要求相一致（见4.1）。

In planning product realization, the organization shall determine the following, as appropriate:
在对产品实现进行策划时，组织应确定以下方面的适当内容：

a) quality objectives and requirements for the product;
a) 产品的质量目标和要求；

b) the need to establish processes, documents, and provide resources specific to the product;
b) 针对产品确定过程、文件和资源的需求；

c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
c) 产品所要求的验证、确认、监视、检验和试验活动，以及产品接收准则；

d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
d) 为实现过程及其产品满足要求提供证据所需的记录。

The output of this planning shall be in a form suitable for the organization's method of operations.
策划的输出形式应适于组织的运作方式。

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.
注：1、对应用于特定产品、项目或合同的质量管理体系的过程（包括产品实现过程）和资源作出规定的文件可称之为质量计划。

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
2、组织也可将7.3的要求应用于产品实现过程的开发。

6.2  Customer-related processes
6.2  与顾客有关的过程

6.2.1          Determination of requirements related to the product
6.2.1 与产品有关的要求的确定

The organization shall determine
组织应确定：

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
a) 顾客规定的要求，包括对交付及交付后活动的要求；

b) requirements not stated by the customer but necessary for specified or intended use, where known,
b) 顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求；

c) statutory and regulatory requirements related to the product, and
c) 与产品有关的法律法规要求；

d) any additional requirements determined by the organization.
d) 组织确定的任何附加要求。

6.2.2 Review of requirements related to the product
6.2.2 与产品有关的要求的评审

The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
组织应评审与产品有关的要求。评审应在组织向顾客作出提供产品的承诺之前进行（如：提交标书、接受合同或订单及接收合同或订单的更改），并应确保：

a) product requirements are defined,
a) 产品要求得到规定；

b) contract or order requirements differing from those previously expressed are resolved, and
b) 与以前表述不一致的合同或订单的要求已予解决；

c) the organization has the ability to meet the defined requirements.
c) 组织有能力满足规定的要求。

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
评审结果及评审所引起的措施的记录应予保持（见4.2.4）。

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
若顾客提供的要求没有形成文件，组织在接收顾客要求前应对顾客要求 进行确认。

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
若产品要求发生变更，组织应确保相关文件得到修改，并确保相关人员知道已变更的要求。

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.
注：在某些情况中，如网上销售，对每一个订单进行正式的评审可能是不实际的。而代之对有关的产品信息，，如产品目录、产品广告内容等进行评审。

6.2.3 Customer communication
6.2.3 顾客沟通

The organization shall determine and implement effective arrangements for communicating with customers in relation to
组织应对以下有关方面确定并实施与顾客沟通的有效安排：

a) product information,
a) 产品信息；

b) enquiries, contracts or order handling, including amendments, and
b) 问询、合同或订单的处理，包括对其的修改；

c) customer feedback, including customer complaints.
c) 顾客反馈，包括顾客投诉。

6.3  Design and development
6.3  设计和开发

6.3.1 Design and development planning
6.3.1 设计和开发策划

The organization shall plan and control the design and development of product.
组织应对产品的设计和开发进行策划和控制。

During the design and development planning, the organization shall determine
在进行设计和开发策划时，组织应确定：

a) the design and development stages,
a) 设计和开发阶段；

b) the review, verification and validation that are appropriate to each design and development stage, and
b) 适于每个设计和开发阶段的评审、验证和确认活动；

c) the responsibilities and authorities for design and development.
c) 设计和开发的职责和权限。

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
组织应对参与设计和开发的不同小组之间的接口实施管理，以确保有效的沟通，并明确职责分工。

Planning output shall be updated, as appropriate, as the design and development progresses.
随设计和开发的进展，在适当时，策划的输出予以更新。

6.3.2 Design and development inputs
6.3.2 设计和开发输入

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include
应确定与产品要求有关的输入，并保持记录（见4.2.4）。这些输入应包括：

a) functional and performance requirements,
a) 功能和性能要求；

b) applicable statutory and regulatory requirements,
b) 适用的法律法规要求；

c) where applicable, information derived from previous similar designs, and
c) 适用时，以前类似设计提供的信息

d) other requirements essential for design and development.
d) 设计和开发所必需的其他要求。

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
应对这些输入进行评审，以确保其充分性与适宜性，要求应完整、清楚，并且不能自相矛盾。

6.3.3 Design and development outputs
6.3.3 设计和开发输出

The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
设计和开发的输出应以能够针对设计和开发的输入进行验证的方式提出，并应在放行前得到批准。

Design and development outputs shall
设计和开发输出应：

a) meet the input requirements for design and development,
a) 满足设计和开发输入的要求；

b) provide appropriate information for purchasing, production and for service provision,
b) 给出采购、生产和服务提供适当的信息；

c) contain or reference product acceptance criteria, and
c) 包含或引用产品接收准则；

d) specify the characteristics of the product that are essential for its safe and proper use.
d) 规定对产品的安全和正常使用所必需的产品特性。

6.3.4 Design and development review
6.3.4 设计和开发评审

At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
在适宜的阶段，应对依据所策划的安排（见7.3.1）设计和开发进行系统的评审，以便：

a) to evaluate the ability of the results of design and development to meet requirements, and
a) 评价设计和开发的结果满足要求的能力；

b) to identify any problems and propose necessary actions.
b) 识别任何问题并提出必要的措施。

Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).
评审的参加者应包括与所评审的设计和开发阶段有关的职能的代表，评审结果及任何必要措施的记录应予保持（见4.2.4）。

6.3.5 Design and development verification
6.3.5 设计和开发验证

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).
为确保设计和开发输出满足输入的要求，应对依据所策划的安排（见7.3.1）设计和开发进行验证。验证结果及任何必要措施的记录应予保持（见4.2.4）。

6.3.6 Design and development validation
6.3.6 设计和开发确认

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).
为确保产品能够满足规定的使用要求或已知预期用途的要求，应依据所策划的安排（见7.3.1）对设计和开发进行确认。只要可行，确认应在产品交付或实施之前完成。确认结果及任何必要措施的记录应予保持（见4.2.4）。

6.3.7 Control of design and development changes
6.3.7 设计和开发更改的控制

Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
应识别设计和开发的更改，并保持记录，在适当时，应对设计和开发的更改进行评审、验证和确认，并在实施前得到批准，设计和开发更改的评审应包括评价更改对产品组成部分和已交付产品的影响。

Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
更改评审结果及任何必要措施的记录应予保持（见4.2.4）。

6.4  Purchasing
6.4  采购

6.4.1 Purchasing process
6.4.1 采购过程

The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
组织应确保采购的产品符合规定的采购要求，对供方及采购的产品控制的类型和程度应取决于采购的产品对随后的产品实现或最终产品的影响。

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).
组织应根据供方按组织的要求提供产品的能力评价和选择供方应制定选择、评价和重新评价的准则。评价结果及评价所引起的任何必要措施的记录应予保持（见4.2.4）。

6.4.2 Purchasing information

6.4.2 采购信息

Purchasing information shall describe the product to be purchased, including where appropriate
采购信息应表述拟采购的产品，适当时包括：

a) requirements for approval of product, procedures, processes and equipment,
a) 产品、程序、过程和设备批准的要求；

b) requirements for qualification of personnel, and
b) 人员资格的要求；

c) quality management system requirements.
c) 质量管理体系的要求。

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
在与供方沟通前，组织应确保规定的采购要求是充分与适宜的。

6.4.3 Verification of purchased product
6.4.3 采购产品的验证

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
组织应确定并实施检验或其他必要的活动，以确保采购的产品满足规定的采购要求。

Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
当组织或其顾客拟在供方的现场实施验证时，组织应在采购信息中对拟验证的安排和产品放行的方法作出规定。

6.5  Production and service provision
6.5  生产和服务提供

6.5.1 Control of production and service provision
6.5.1 生产和服务提供的控制

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
组织应策划并在受控条件下进行生产和服务提供，适用时，受控条件应包括：

a) the availability of information that describes the characteristics of the product,
a) 获得表述产品特性的信息；

b) the availability of work instructions, as necessary,
b) 获得作业指导书；

c) the use of suitable equipment,
c) 使用适宜的设备；

d) the availability and use of monitoring and measuring devices,
d) 获得和使用监视和测量装置；

e) the implementation of monitoring and measurement, and
e) 实施监视和测量；

f) the implementation of release, delivery and post-delivery activities.
f) 放行、交付和交付后活动的实施。

6.5.2 Validation of processes for production and service provision
6.5.2 生产和服务提供过程的确认

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
当生产和服务提供过程的输出不能由后续的监视或测量加以验证时，组织应对任何这样的过程实施确认。这包括仅在产品使用或服务已交付之后问题才显现的过程。

Validation shall demonstrate the ability of these processes to achieve planned results.
确认应证实这些过程实现所策划的结果的能力。

The organization shall establish arrangements for these processes including, as applicable
组织应规定确认这些过程的安排，适用时包括：

a) defined criteria for review and approval of the processes,
a) 为过程的评审和批准所规定的准则；

b) approval of equipment and qualification of personnel,
b) 设备的认可和人员资格的鉴定；

c) use of specific methods and procedures,
c) 使用特定的方法和程序；

d) requirements for records (see 4.2.4), and
d) 记录的要求（见4.2.4）；

e) revalidation.
e) 再确认。

6.5.3 Identification and traceability
6.5.3 标识和可追溯性

Where appropriate, the organization shall identify the product by suitable means throughout product realization.
适当时，组织应在产品实现的全过程中使用适宜的方法识别产品

The organization shall identify the product status with respect to monitoring and measurement requirements.
组织应针对监视和测量要求识别产品的状态。

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).
在有可追溯性要求的场合，组织应控制并记录产品的唯一性标识（见4.2.4）。

NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.
注：在某些行业，技术状态管理是保持标识和可追溯性的一种方法。

6.5.4 Customer property
6.5.4 顾客财产

The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).
组织应爱护在组织控制下或组织使用的顾客财产。组织应识别、验证、保护和维护供其使用或构成产品一部分的顾客财产。若顾客财产发生丢失、损坏或发现不适用的情况时，应报告顾客，并保持记录（见4.2.4）。

NOTE Customer property can include intellectual property.
注：顾客财产可包括知识产权。

6.5.5 Preservation of product
6.5.5 产品防护

The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.
在内部处理和交付到预定的地点其间，组织应针对产品的符合性提供防护，这种防护应包括标识、搬运、包装、贮存和保护。防护也应适用于产品的组成部分。

6.6  Control of monitoring and measuring devices
6.6  监视和测量装置的控制

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).
组织应确定需实施的监视和测量以及所需的监视和测量装置，提供证据，为产品符合确定的要求（见7.2.1）。

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
组织应建立过程，以确保监视和测量活动可行并以与监视和测量的要求相一致的方式实施。

Where necessary to ensure valid results, measuring equipment shall
当有必要确保结果有效的场合时，测量设备应：

a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
a) 对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前进行校准或检定。当不存在上述标准时，应记录校准或检定的依据；

b) be adjusted or re-adjusted as necessary;
b) 必要时进行调整或再调整；

c) be identified to enable the calibration status to be determined;
c) 得到识别，以确定其校准状态；

d) be safeguarded from adjustments that would invalidate the measurement result;
d) 防止可能使测量结果失效的调整；

e) be protected from damage and deterioration during handling, maintenance and storage.
e) 在搬运、维护和贮存期间防止损坏或失效；

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).
此外，当发现设备不符合要求时，组织应对以往测量结果的有效性进行评价和记录。组织应对该设备和任何受影响的产品采取适当的措施。校准和验证结果的记录应予保持（见4.2.4）。

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
当用于规定要求的监视和测量时，计算机软年满足预期用途的能力应予以确认，确认应在初次使用前进行，并在必要时予以重新确认。

NOTE See ISO 10012-1 and ISO 10012-2 for guidance.
注：作为指南，参见ISO 10012-1和ISO 10012-2。

7  Measurement, analysis and improvement
7  测量、分析和改进

7.1  General
7.1  总则

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
组织应策划并实施以下方面所需的监视、测量、分析和改进过程：

a) to demonstrate conformity of the product,
a) 证实产品的符合性；

b) to ensure conformity of the quality management system, and
b) 确保质量管理体系的符合性；

c) to continually improve the effectiveness of the quality management system.
c) 持续改进质量管理体系的有效性。

This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
这应包括对统计技术在内的适用方法及其应用程度的确定。

7.2  Monitoring and measurement
7.2  监视和测量

7.2.1 Customer satisfaction
7.2.1 顾客满意

As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.
作为对质量管理体系业绩的一种测量，组织应监视顾客关于组织是否满足其要求的感受的相关信息，并确定获取和利用这种信息的方法。

7.2.2 Internal audit
7.2.2 内部审核

The organization shall conduct internal audits at planned intervals to determine whether the quality management system
组织应按策划的时间间隔进行内部审核，以确定质量管理体系是否：

a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
a) 符合策划的安排（见7.1）、本标准的要求以及组织所确定的质量管理体系的要求；

b) is effectively implemented and maintained.
b) 得到有效实施与保持。

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.
考虑拟审核的过程和区域的状况和重要性以及以往审核的结果，组织应对审核方案进行策划。应规定审核的准则、范围、频次和方法。审核员的选择和审核的实施应确保审核过程的客观性和公正性。

Auditors shall not audit their own work.
审核员不应审核自己的工作。

The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
策划和实施审核以及报告结果和保持记录（见4.2.4）的职责和要求应在形成文件的程序中作出规定。

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).
负责受审区域的管理者应确保及时采取措施，以消除向发现和不合格及其原因。跟踪活动应包括对所采取措施的验证和验证结果的报告（见8.5.2）。

NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
注：作为指南，参见ISO 10011-1, ISO 10011-2 和 ISO 10011-3。

7.2.3 Monitoring and measurement of processes
7.2.3 过程的监视和测量

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality anagement system processes. These methods shall demonstrate the ability of the processes to achieve planned esults. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to nsure conformity of the product.
组织应采用适宜的方法对质量管理体系过程进行监视，并在适用时进行测量。这些方法应证实过程实现所策划的结果的能力。当未能达到所策划的结果时，应采取适当的纠正和纠正措施，以确保产品的符合性。

7.2.4 Monitoring and measurement of product
7.2.4 产品的监视和测量

The organization shall monitor and measure the characteristics of the product to verify that product requirements ave been met. This shall be carried out at appropriate stages of the product realization process in accordance with he planned arrangements (see 7.1).
组织应对产品的特性进行监视和测量，以验证产品要求已得到满足。这种监视和测量应依据所策划的安排（见7.1），在产品实现过程的适当阶段进行。

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) uthorizing release of product (see 4.2.4).
应保持符合接收准则的证据。记录应指明有权放行产品的人员（见4.2.4）。

Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been atisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
除非得到有关授权人员的批准，适用时得到顾客的批准，否则在策划的安排（见7.1）已圆满完成之前，不能放行产品和交付服务。

7.3  Control of nonconforming product
7.3  不合格品控制

The organization shall ensure that product which does not conform to product requirements is identified and ontrolled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for ealing with nonconforming product shall be defined in a documented procedure.
组织应确保不符合产品要求的产品得到识别和控制，以防止其非预期的使用或交付。不合格品控制以及不合格品处置的有关职责和权限应在形成文件的程序中作出规定。

The organization shall deal with nonconforming product by one or more of the following ways:
组织应通过下列一种或几种途径，处置不合格品。

a) by taking action to eliminate the detected nonconformity;
a) 采取措施，消除发现的不合格；

b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by he customer;
b) 经有关授权人员批准，适用时经顾客批准，让步使用、放行或接收不合格品；

c) by taking action to preclude its original intended use or application.
c) 采取措施，防止其原预期的使用或应用。

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).
应保持不合格的性质以及随后所采取的任何措施的记录，包括所批准的让步的记录（见4.2.4）。

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
应对纠正后的产品再次进行验证，以证实符合要求。

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.
当在交付或开始使用后发现产品不合格时，组织应采取与不合格的影响或潜在影响的程度相适应的措施。

7.4  Analysis of data
7.4  数据分析

The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
组织应确定、收集和分析适当的数据，以证实质量管理体系的适宜性和有效性，并评价在何处可以持续改进质量管理体系的有效性。这应包括来自监视和测量的结果以及其他有关来源的数据。

The analysis of data shall provide information relating to
数据分析应提供有关以下方面的信息：

a) customer satisfaction (see 8.2.1),
a) 顾客满意（见8.2.1）；

b) conformity to product requirements (see 7.2.1),
b) 与产品要求的符合性（见7.2.1）；

c) characteristics and trends of processes and products including opportunities for preventive action, and
c) 过程和产品的特性趋势，包括采取预防措施的机会；

d) suppliers.
d) 供方。

7.5  Improvement
7.5  改进

7.5.1 Continual improvement
7.5.1 持续改进

The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
组织应利用质量方针、质量目标、审核结果、数据分析、纠正和预防措施以及管理评审，持续改进质量管理体系的有效性。

7.5.2 Corrective action

7.5.2 纠正措施

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
组织应采取措施，以消除不合格的原因，防止不合格的再发生。

Corrective actions shall be appropriate to the effects of the nonconformities encountered.
纠正措施应与所遇到的不合格的影响程度相适应。

A documented procedure shall be established to define requirements for
应编制形成文件的程序，以规定以下方面的要求：

a) reviewing nonconformities (including customer complaints),
a) 评审不合格（包括顾客投诉）；

b) determining the causes of nonconformities ,
b) 确定不合格的原因；

c) evaluating the need for action to ensure that nonconformities do not recur,
c) 评价确保不合格不再发生的措施的需求；

d) determining and implementing action needed,
d) 确定和实施所需的措施；

e) records of the results of action taken (see 4.2.4), and
e) 记录所采取措施的结果（见4.2.4）；

f) reviewing corrective action taken.
f) 评审所采取的纠正措施。

7.5.3 Preventive action
7.5.3 预防措施

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
组织应确定措施，以消除潜在不合格的原因，防止不合格的发生。预防措施应与潜在问题的影响程度相适应。

A documented procedure shall be established to define requirements for
应编制形成文件的程序，以规定以下方面的要求：

a) determining potential nonconformities and their causes,
a) 确定潜在不合格及其原因；

b) evaluating the need for action to prevent occurrence of nonconformities,
b) 评价防止不合格发生的措施的需求；

c) determining and implementing action needed,
c) 确定并实施所需的措施；

d) records of results of action taken (see 4.2.4), and
d) 记录所采取措施的结果（见4.2.4）；

e) reviewing preventive action taken.
e) 评审所采取的预防措施。