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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 processes 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
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.

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.

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.

1 Normative reference

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.

ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.

2 Terms and definitions

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

The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:

supplier organization customer

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”.

Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.

3  Quality management system

3.1  General requirements

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.

The organization shall

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.

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.

NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

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

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.

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to 

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.

3.2.2 Quality manual
3.2.2 质量手册

The organization shall establish and maintain a quality manual that includes

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.

A documented procedure shall be established to define the controls needed:

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.

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

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).

4.3  Quality policy
4.3  质量方针

Top management shall ensure that the quality policy

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

Top management shall ensure that

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.

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

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.

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.

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.

Records from management reviews shall be maintained (see 4.2.4).

4.6.2 Review input
4.6.2 评审输入

The input to management review shall include information on

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

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

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.

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

The organization shall

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

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.

6  Product realization
6  产品实现

6.1  Planning of product realization

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).

In planning product realization, the organization shall determine the following, as appropriate:

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.

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.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.

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

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

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).

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.

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.

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

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.

During the design and development planning, the organization shall determine

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.

Planning output shall be updated, as appropriate, as the design and development progresses.

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

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.

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.

Design and development outputs shall

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)

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).

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).

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).

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.

Records of the results of the review of changes and any necessary actions shall be maintained (see 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.

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).

6.4.2 Purchasing information

6.4.2 采购信息

Purchasing information shall describe the product to be purchased, including where appropriate

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.

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.

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.

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

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.

Validation shall demonstrate the ability of these processes to achieve planned results.

The organization shall establish arrangements for these processes including, as applicable

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.

The organization shall identify the product status with respect to monitoring and measurement requirements.

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.

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).

NOTE Customer property can include intellectual property.

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.

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).

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.

Where necessary to ensure valid results, measuring equipment shall

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).

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.

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

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.

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.

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

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.

Auditors shall not audit their own work.

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.

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).

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.

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).

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) uthorizing release of product (see 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.

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.

The organization shall deal with nonconforming product by one or more of the following ways:

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).

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

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.

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.

The analysis of data shall provide information relating to

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.

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.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

A documented procedure shall be established to define requirements for

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.

A documented procedure shall be established to define requirements for

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。

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