加载中…国际质量管理体系——要求（二）中英文对照
(2011-03-03 09:37:49)
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INTERNATIONAL
STANDARD国际标准
ISO 9001
Third edition
第三版
2000-12-15
Quality
质量管理体系 — 要求
(二)
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7.2.3 Customer communication
The organization shall determine and implement effective arrangements for communication 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：
product information,
enquiries, contracts or order handing, including amendments, and
customer feedback, including customer complaints.
7.3 Design and development
7.3.1 Design and development planning
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：
the design and development stages,
the review, verification and validation that are appropriate to each design and development stage, and
the responsibilities and authorities for design and development.
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进行管理，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，策划的输出应予以更新。
7.3.2 Design and development inputs
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：
functional and performance requirements,
where applicable, information derived from previous similar designs, and
other requirements essential for design and development.
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，以确保输入是充分与适宜的。要求应完整、清楚，并且不能自相矛盾。
7.3.3 Design and development outputs
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：
meet the input requirements for design and development,
provide appropriate information for purchasing, production and for service provision,
contain or reference product acceptance criteria, and
specify the characteristics of the product that are essential for its safe and proper use .
7.3.4 Design and development review
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，应依据所策划的安排（见7.3.1）对设计和开发进行系统的评审，以便：
to evaluate the ability of the results of design and development to meet requirements, and
to identify any problems and propose necessary actions.
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以保持（见4.2.4）。
7.3.5 Design and development verification
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，应依据所策划的安排（见7.3.1）对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以保持（见4.2.4）。
7.3.6 Design and development validation
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的预期用途的要求，应按所策划的安排（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）。
7.3.7 Control of design and development changes
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。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).
更改的评审结果及任何必要措施的记录应予保持（见4.2.4）。
7.4 Purchasing
7.4.1 Purchasing process
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发的任何必要措施的记录应予保持（见4.2.4）。
7.4.2 Purchasing information
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：
requirements for approval of product, procedures, processes, and equipment,
requirements for qualification of personnel, and
quality management system requirements.
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。
7.4.3 Verification of purchased product
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。
7.5 Production and service provision
7.5.1 Control of production and service provision
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：
the availability of information that describes the characteristics of the product,
the availability of work instructions, as necessary,
必要时，获得作业指导书；
the use of suitable equipment,
the availability and use of monitoring and measuring devices,
the implementation of monitoring and measurement, and
the implementation of release, delivery and
post-delivery
7.5.2 Validation of processes for production and service provision
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
组织应对这些过程作出安排，适用时包括：
defined criteria for review and approval of the processes,
approval of equipment and qualification of personnel,
use of specific methods and procedures,
requirements for records (see 4.2.4),and
revalidation.
7.5.3 Identification and traceability
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
注：
7.5.4 Customer property
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 us, 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
注：
7.5.5 Preservation of product
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handing, 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期间，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。
7.6 Control of monitoring and measuring devices
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，为产品符合确定的要求（见7.2.1）提供证据。
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:
为确保结果有效，必要时，测量设备应：
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;
be adjusted or re-adjusted as necessary;
be identified to enable calibration status to be determined;
be safeguarded from adjustments that would invalidate the measurement result;
be protected from damage and deterioration during handling, maintenance and storage.
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.
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 use 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.
当计算机软件用于规定要求的监视和测量时，应确认其满足预期用途的能力。确认应在初次使用前进行，必要时再确认。
NOTE:
注：
8 Measurement, analysis and improvement
8.1 General
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：
to demonstrate conformity of the product,
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
这应包括统计技术在内的适用方法及应用程度的确定。
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
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，组织应对顾客有关组织是否已满足其要求的感受的信息进行监视，并确定获取和利用这种信息的方法。
8.2.2 Internal audit
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：
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
is effectively implemented and maintained.
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.
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，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。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 record (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，以消除所发现的不合格及其原因。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
注：
8.2.3 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure 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，在适当时，应采取纠正和纠正措施，以确保产品的符合性。
8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried but at appropriate stages of the product realization process in accordance with the 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) authorizing 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 all
the planned arrangements (see 7.1) have bee satisfactorily
completed, unless otherwise approved by a relevant authority and,
where applicable,
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，不应放行产品和交付服务。
8.3 Control of nonconforming product
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing 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:
组织应采取下列一种或几种途径，处置不合格品：
by taking action to eliminate the detected nonconformity;
by authorizing its use, release or acceptance under concession
by a relevant
by taking action to preclude its original intended use or application.
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 he requirements.
在不合格品得到纠正之后应对其再次进行验证，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。
8.4 Analysis of data
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 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
数据分析应提供以下方面的有关信息：
customer satisfaction (see 8.2.1),
conformance to product requirements (see 7.2.1),
characteristics and trends of processes and products including opportunities for preventive action, and
suppliers.
8.5 Improvement
8.5.1 Continual improvement
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objective, audit result 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。
8.5.2 Corrective action
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 conconformities encountered.
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。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：
reviewing nonconformities (including customer complaints),
determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities do not recur,
determining and implementing the action needed,
records of the results of action taken (see 4.2.4), and
reviewing corrective action taken.
8.5.3 Preventive action
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：
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
records of results of action taken (see 4.2.4), and
reviewing
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