d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
d) 為實現(xiàn)過程及其產(chǎn)品滿足要求提供證據(jù)所需的記錄。
The output of this planning shall be in a form suitable for the organization's method of operations.
策劃的輸出形式應(yīng)適于組織的運作方式。
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、對應(yīng)用于特定產(chǎn)品、項目或合同的質(zhì)量管理體系的過程（包括產(chǎn)品實現(xiàn)過程）和資源作出規(guī)定的文件可稱之為質(zhì)量計劃。
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
2、組織也可將7.3的要求應(yīng)用于產(chǎn)品實現(xiàn)過程的開發(fā)。
6.2 Customer-related processes
7.2 與顧客有關(guān)的過程
6.2.1 Determination of requirements related to the product
7.2.1 與產(chǎn)品有關(guān)的要求的確定
The organization shall determine
組織應(yīng)確定：
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
a) 顧客規(guī)定的要求，包括對交付及交付后活動的要求；
b) requirements not stated by the customer but necessary for specified or intended use, where known,
b) 顧客雖然沒有明示，但規(guī)定的用途或已知的預期用途所必需的要求；
c) statutory and regulatory requirements related to the product, and
c) 與產(chǎn)品有關(guān)的法律法規(guī)要求；
d) any additional requirements determined by the organization.
d) 組織確定的任何附加要求。
6.2.2 Review of requirements related to the product
7.2.2 與產(chǎn)品有關(guān)的要求的評審
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
組織應(yīng)評審與產(chǎn)品有關(guān)的要求。評審應(yīng)在組織向顧客作出提供產(chǎn)品的承諾之前進行（如：提交標書、接受合同或訂單及接收合同或訂單的更改），并應(yīng)確保：
a) product requirements are defined,
a) 產(chǎn)品要求得到規(guī)定；
b) contract or order requirements differing from those previously expressed are resolved, and
b) 與以前表述不一致的合同或訂單的要求已予解決；
c) the organization has the ability to meet the defined requirements.
c) 組織有能力滿足規(guī)定的要求。
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
評審結(jié)果及評審所引起的措施的記錄應(yīng)予保持（見4.2.4）。
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
若顧客提供的要求沒有形成文件，組織在接收顧客要求前應(yīng)對顧客要求 進行確認。
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.
若產(chǎn)品要求發(fā)生變更，組織應(yīng)確保相關(guān)文件得到修改，并確保相關(guān)人員知道已變更的要求。
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：在某些情況中，如網(wǎng)上銷售，對每一個訂單進行正式的評審可能是不實際的。而代之對有關(guān)的產(chǎn)品信息，，如產(chǎn)品目錄、產(chǎn)品廣告內(nèi)容等進行評審。
6.2.3 Customer communication
7.2.3 顧客溝通
The organization shall determine and implement effective arrangements for communicating with customers in relation to
組織應(yīng)對以下有關(guān)方面確定并實施與顧客溝通的有效安排：
a) product information,
a) 產(chǎn)品信息；
b) enquiries, contracts or order handling, including amendments, and
b) 問詢、合同或訂單的處理，包括對其的修改；
c) customer feedback, including customer complaints.
c) 顧客反饋，包括顧客投訴。
6.3 Design and development
7.3 設(shè)計和開發(fā)
6.3.1 Design and development planning
7.3.1 設(shè)計和開發(fā)策劃
The organization shall plan and control the design and development of product.
組織應(yīng)對產(chǎn)品的設(shè)計和開發(fā)進行策劃和控制。
During the design and development planning, the organization shall determine
在進行設(shè)計和開發(fā)策劃時，組織應(yīng)確定：
a) the design and development stages,
a) 設(shè)計和開發(fā)階段；
b) the review, verification and validation that are appropriate to each design and development stage, and
b) 適于每個設(shè)計和開發(fā)階段的評審、驗證和確認活動；
c) the responsibilities and authorities for design and development.
c) 設(shè)計和開發(fā)的職責和權(quán)限。
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
組織應(yīng)對參與設(shè)計和開發(fā)的不同小組之間的接口實施管理，以確保有效的溝通，并明確職責分工。
Planning output shall be updated, as appropriate, as the design and development progresses.
隨設(shè)計和開發(fā)的進展，在適當時，策劃的輸出予以更新。
6.3.2 Design and development inputs
7.3.2 設(shè)計和開發(fā)輸入
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include
應(yīng)確定與產(chǎn)品要求有關(guān)的輸入，并保持記錄（見4.2.4）。這些輸入應(yīng)包括：
a) functional and performance requirements,
a) 功能和性能要求；
b) applicable statutory and regulatory requirements,
b) 適用的法律法規(guī)要求；
c) where applicable, information derived from previous similar designs, and
c) 適用時，以前類似設(shè)計提供的信息
d) other requirements essential for design and development.
d) 設(shè)計和開發(fā)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.
應(yīng)對這些輸入進行評審，以確保其充分性與適宜性，要求應(yīng)完整、清楚，并且不能自相矛盾。
6.3.3 Design and development outputs
7.3.3 設(shè)計和開發(fā)輸出
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.
設(shè)計和開發(fā)的輸出應(yīng)以能夠針對設(shè)計和開發(fā)的輸入進行驗證的方式提出，并應(yīng)在放行前得到批準。
Design and development outputs shall
設(shè)計和開發(fā)輸出應(yīng)：
a) meet the input requirements for design and development,
a) 滿足設(shè)計和開發(fā)輸入的要求；
b) provide appropriate information for purchasing, production and for service provision,
b) 給出采購、生產(chǎn)和服務(wù)提供適當?shù)男畔ⅲ?/span>
c) contain or reference product acceptance criteria, and
c) 包含或引用產(chǎn)品接收準則；
d) specify the characteristics of the product that are essential for its safe and proper use.
d) 規(guī)定對產(chǎn)品的安全和正常使用所必需的產(chǎn)品特性。
6.3.4 Design and development review
7.3.4 設(shè)計和開發(fā)評審
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
在適宜的階段，應(yīng)對依據(jù)所策劃的安排（見7.3.1）設(shè)計和開發(fā)進行系統(tǒng)的評審，以便：
a) to evaluate the ability of the results of design and development to meet requirements, and
a) 評價設(shè)計和開發(fā)的結(jié)果滿足要求的能力；
b) to identify any problems and propose necessary actions.
b) 識別任何問題并提出必要的措施。
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).
評審的參加者應(yīng)包括與所評審的設(shè)計和開發(fā)階段有關(guān)的職能的代表，評審結(jié)果及任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.3.5 Design and development verification
7.3.5 設(shè)計和開發(fā)驗證
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).
為確保設(shè)計和開發(fā)輸出滿足輸入的要求，應(yīng)對依據(jù)所策劃的安排（見7.3.1）設(shè)計和開發(fā)進行驗證。驗證結(jié)果及任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.3.6 Design and development validation
7.3.6 設(shè)計和開發(fā)確認
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).
為確保產(chǎn)品能夠滿足規(guī)定的使用要求或已知預期用途的要求，應(yīng)依據(jù)所策劃的安排（見7.3.1）對設(shè)計和開發(fā)進行確認。只要可行，確認應(yīng)在產(chǎn)品交付或?qū)嵤┲巴瓿?。確認結(jié)果及任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.3.7 Control of design and development changes
7.3.7 設(shè)計和開發(fā)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.
應(yīng)識別設(shè)計和開發(fā)的更改，并保持記錄，在適當時，應(yīng)對設(shè)計和開發(fā)的更改進行評審、驗證和確認，并在實施前得到批準，設(shè)計和開發(fā)更改的評審應(yīng)包括評價更改對產(chǎn)品組成部分和已交付產(chǎn)品的影響。
Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
更改評審結(jié)果及任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.4 Purchasing
7.4 采購
6.4.1 Purchasing process
7.4.1 采購過程
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.
組織應(yīng)確保采購的產(chǎn)品符合規(guī)定的采購要求，對供方及采購的產(chǎn)品控制的類型和程度應(yīng)取決于采購的產(chǎn)品對隨后的產(chǎn)品實現(xiàn)或最終產(chǎn)品的影響。
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).
組織應(yīng)根據(jù)供方按組織的要求提供產(chǎn)品的能力評價和選擇供方應(yīng)制定選擇、評價和重新評價的準則。評價結(jié)果及評價所引起的任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.4.2 Purchasing information
7.4.2 采購信息
Purchasing information shall describe the product to be purchased, including where appropriate
采購信息應(yīng)表述擬采購的產(chǎn)品，適當時包括：
a) requirements for approval of product, procedures, processes and equipment,
a) 產(chǎn)品、程序、過程和設(shè)備批準的要求；
b) requirements for qualification of personnel, and
b) 人員資格的要求；
c) quality management system requirements.
c) 質(zhì)量管理體系的要求。
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
在與供方溝通前，組織應(yīng)確保規(guī)定的采購要求是充分與適宜的。
6.4.3 Verification of purchased product
7.4.3 采購產(chǎn)品的驗證
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
組織應(yīng)確定并實施檢驗或其他必要的活動，以確保采購的產(chǎn)品滿足規(guī)定的采購要求。
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.
當組織或其顧客擬在供方的現(xiàn)場實施驗證時，組織應(yīng)在采購信息中對擬驗證的安排和產(chǎn)品放行的方法作出規(guī)定。
6.5 Production and service provision
7.5 生產(chǎn)和服務(wù)提供
6.5.1 Control of production and service provision
7.5.1 生產(chǎn)和服務(wù)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
組織應(yīng)策劃并在受控條件下進行生產(chǎn)和服務(wù)提供，適用時，受控條件應(yīng)包括：
a) the availability of information that describes the characteristics of the product,
a) 獲得表述產(chǎn)品特性的信息；
b) the availability of work instructions, as necessary,
b) 獲得作業(yè)指導書；
c) the use of suitable equipment,
c) 使用適宜的設(shè)備；
d) the availability and use of monitoring and measuring devices,
d) 獲得和使用監(jiān)視和測量裝置；
e) the implementation of monitoring and measurement, and
e) 實施監(jiān)視和測量；
f) the implementation of release, delivery and post-delivery activities.
f) 放行、交付和交付后活動的實施。
6.5.2 Validation of processes for production and service provision
7.5.2 生產(chǎn)和服務(wù)提供過程的確認
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.
當生產(chǎn)和服務(wù)提供過程的輸出不能由后續(xù)的監(jiān)視或測量加以驗證時，組織應(yīng)對任何這樣的過程實施確認。這包括僅在產(chǎn)品使用或服務(wù)已交付之后問題才顯現(xiàn)的過程。
Validation shall demonstrate the ability of these processes to achieve planned results.
確認應(yīng)證實這些過程實現(xiàn)所策劃的結(jié)果的能力。
The organization shall establish arrangements for these processes including, as applicable
組織應(yīng)規(guī)定確認這些過程的安排，適用時包括：
a) defined criteria for review and approval of the processes,
a) 為過程的評審和批準所規(guī)定的準則；
b) approval of equipment and qualification of personnel,
b) 設(shè)備的認可和人員資格的鑒定；
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) 記錄的要求（見4.2.4）；
e) revalidation.
e) 再確認。
6.5.3 Identification and traceability
7.5.3 標識和可追溯性
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
適當時，組織應(yīng)在產(chǎn)品實現(xiàn)的全過程中使用適宜的方法識別產(chǎn)品
The organization shall identify the product status with respect to monitoring and measurement requirements.
組織應(yīng)針對監(jiān)視和測量要求識別產(chǎn)品的狀態(tài)。
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場合，組織應(yīng)控制并記錄產(chǎn)品的唯一性標識（見4.2.4）。
NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.
注：在某些行業(yè)，技術(shù)狀態(tài)管理是保持標識和可追溯性的一種方法。
6.5.4 Customer property
7.5.4 顧客財產(chǎn)
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).
組織應(yīng)愛護在組織控制下或組織使用的顧客財產(chǎn)。組織應(yīng)識別、驗證、保護和維護供其使用或構(gòu)成產(chǎn)品一部分的顧客財產(chǎn)。若顧客財產(chǎn)發(fā)生丟失、損壞或發(fā)現(xiàn)不適用的情況時，應(yīng)報告顧客，并保持記錄（見4.2.4）。
NOTE Customer property can include intellectual property.
注：顧客財產(chǎn)可包括知識產(chǎn)權(quán)。
6.5.5 Preservation of product
7.5.5 產(chǎn)品防護
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.
在內(nèi)部處理和交付到預定的地點其間，組織應(yīng)針對產(chǎn)品的符合性提供防護，這種防護應(yīng)包括標識、搬運、包裝、貯存和保護。防護也應(yīng)適用于產(chǎn)品的組成部分。
6.6 Control of monitoring and measuring devices
7.6 監(jiān)視和測量裝置的控制
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).
組織應(yīng)確定需實施的監(jiān)視和測量以及所需的監(jiān)視和測量裝置，提供證據(jù)，為產(chǎn)品符合確定的要求（見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.
組織應(yīng)建立過程，以確保監(jiān)視和測量活動可行并以與監(jiān)視和測量的要求相一致的方式實施。
Where necessary to ensure valid results, measuring equipment shall
當有必要確保結(jié)果有效的場合時，測量設(shè)備應(yīng)：
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) 對照能溯源到國際或國家標準的測量標準，按照規(guī)定的時間間隔或在使用前進行校準或檢定。當不存在上述標準時，應(yīng)記錄校準或檢定的依據(jù)；
b) be adjusted or re-adjusted as necessary;
b) 必要時進行調(diào)整或再調(diào)整；
c) be identified to enable the calibration status to be determined;
c) 得到識別，以確定其校準狀態(tài)；
d) be safeguarded from adjustments that would invalidate the measurement result;
d) 防止可能使測量結(jié)果失效的調(diào)整；
e) be protected from damage and deterioration during handling, maintenance and storage.
e) 在搬運、維護和貯存期間防止損壞或失效；
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，當發(fā)現(xiàn)設(shè)備不符合要求時，組織應(yīng)對以往測量結(jié)果的有效性進行評價和記錄。組織應(yīng)對該設(shè)備和任何受影響的產(chǎn)品采取適當?shù)拇胧Ｐ屎万炞C結(jié)果的記錄應(yīng)予保持（見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.
當用于規(guī)定要求的監(jiān)視和測量時，計算機軟年滿足預期用途的能力應(yīng)予以確認，確認應(yīng)在初次使用前進行，并在必要時予以重新確認。
NOTE See ISO 10012-1 and ISO 10012-2 for guidance.
注：作為指南，參見ISO 10012-1和ISO 10012-2。
7 Measurement, analysis and improvement
8 測量、分析和改進
7.1 General
8.1 總則
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
組織應(yīng)策劃并實施以下方面所需的監(jiān)視、測量、分析和改進過程：
a) to demonstrate conformity of the product,
a) 證實產(chǎn)品的符合性；
b) to ensure conformity of the quality management system, and
b) 確保質(zhì)量管理體系的符合性；
c) to continually improve the effectiveness of the quality management system.
c) 持續(xù)改進質(zhì)量管理體系的有效性。
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
這應(yīng)包括對統(tǒng)計技術(shù)在內(nèi)的適用方法及其應(yīng)用程度的確定。
7.2 Monitoring and measurement
8.2 監(jiān)視和測量
7.2.1 Customer satisfaction
8.2.1 顧客滿意
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.
作為對質(zhì)量管理體系業(yè)績的一種測量，組織應(yīng)監(jiān)視顧客關(guān)于組織是否滿足其要求的感受的相關(guān)信息，并確定獲取和利用這種信息的方法。
7.2.2 Internal audit
8.2.2 內(nèi)部審核
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
組織應(yīng)按策劃的時間間隔進行內(nèi)部審核，以確定質(zhì)量管理體系是否：
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) 符合策劃的安排（見7.1）、本標準的要求以及組織所確定的質(zhì)量管理體系的要求；
b) is effectively implemented and maintained.
b) 得到有效實施與保持。
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.
考慮擬審核的過程和區(qū)域的狀況和重要性以及以往審核的結(jié)果，組織應(yīng)對審核方案進行策劃。應(yīng)規(guī)定審核的準則、范圍、頻次和方法。審核員的選擇和審核的實施應(yīng)確保審核過程的客觀性和公正性。
Auditors shall not audit their own work.
審核員不應(yīng)審核自己的工作。
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.
策劃和實施審核以及報告結(jié)果和保持記錄（見4.2.4）的職責和要求應(yīng)在形成文件的程序中作出規(guī)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).
負責受審區(qū)域的管理者應(yīng)確保及時采取措施，以消除向發(fā)現(xiàn)和不合格及其原因。跟蹤活動應(yīng)包括對所采取措施的驗證和驗證結(jié)果的報告（見8.5.2）。
NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
注：作為指南，參見ISO 10011-1, ISO 10011-2 和 ISO 10011-3。
7.2.3 Monitoring and measurement of processes
8.2.3 過程的監(jiān)視和測量
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.
組織應(yīng)采用適宜的方法對質(zhì)量管理體系過程進行監(jiān)視，并在適用時進行測量。這些方法應(yīng)證實過程實現(xiàn)所策劃的結(jié)果的能力。當未能達到所策劃的結(jié)果時，應(yīng)采取適當?shù)募m正和糾正措施，以確保產(chǎn)品的符合性。
7.2.4 Monitoring and measurement of product
8.2.4 產(chǎn)品的監(jiān)視和測量
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).
組織應(yīng)對產(chǎn)品的特性進行監(jiān)視和測量，以驗證產(chǎn)品要求已得到滿足。這種監(jiān)視和測量應(yīng)依據(jù)所策劃的安排（見7.1），在產(chǎn)品實現(xiàn)過程的適當階段進行。
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) uthorizing release of product (see 4.2.4).
應(yīng)保持符合接收準則的證據(jù)。記錄應(yīng)指明有權(quán)放行產(chǎn)品的人員（見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.
除非得到有關(guān)授權(quán)人員的批準，適用時得到顧客的批準，否則在策劃的安排（見7.1）已圓滿完成之前，不能放行產(chǎn)品和交付服務(wù)。
7.3 Control of nonconforming product
8.3 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.
組織應(yīng)確保不符合產(chǎn)品要求的產(chǎn)品得到識別和控制，以防止其非預期的使用或交付。不合格品控制以及不合格品處置的有關(guān)職責和權(quán)限應(yīng)在形成文件的程序中作出規(guī)定。
The organization shall deal with nonconforming product by one or more of the following ways:
組織應(yīng)通過下列一種或幾種途徑，處置不合格品。
a) by taking action to eliminate the detected nonconformity;
a) 采取措施，消除發(fā)現(xiàn)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) 經(jīng)有關(guān)授權(quán)人員批準，適用時經(jīng)顧客批準，讓步使用、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，防止其原預期的使用或應(yīng)用。
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).
應(yīng)保持不合格的性質(zhì)以及隨后所采取的任何措施的記錄，包括所批準的讓步的記錄（見4.2.4）。
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
應(yīng)對糾正后的產(chǎn)品再次進行驗證，以證實符合要求。
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.
當在交付或開始使用后發(fā)現(xiàn)產(chǎn)品不合格時，組織應(yīng)采取與不合格的影響或潛在影響的程度相適應(yīng)的措施。
7.4 Analysis of data
8.4 數(shù)據(jù)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.
組織應(yīng)確定、收集和分析適當?shù)臄?shù)據(jù)，以證實質(zhì)量管理體系的適宜性和有效性，并評價在何處可以持續(xù)改進質(zhì)量管理體系的有效性。這應(yīng)包括來自監(jiān)視和測量的結(jié)果以及其他有關(guān)來源的數(shù)據(jù)。
The analysis of data shall provide information relating to
數(shù)據(jù)分析應(yīng)提供有關(guān)以下方面的信息：
a) customer satisfaction (see 8.2.1),
a) 顧客滿意（見8.2.1）；
b) conformity to product requirements (see 7.2.1),
b) 與產(chǎn)品要求的符合性（見7.2.1）；
c) characteristics and trends of processes and products including opportunities for preventive action, and
c) 過程和產(chǎn)品的特性趨勢，包括采取預防措施的機會；
d) suppliers.
d) 供方。
7.5 Improvement
8.5 改進
7.5.1 Continual improvement
8.5.1 持續(xù)改進
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.
組織應(yīng)利用質(zhì)量方針、質(zhì)量目標、審核結(jié)果、數(shù)據(jù)分析、糾正和預防措施以及管理評審，持續(xù)改進質(zhì)量管理體系的有效性。
7.5.2 Corrective action
8.5.2 糾正措施
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
組織應(yīng)采取措施，以消除不合格的原因，防止不合格的再發(fā)生。
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
糾正措施應(yīng)與所遇到的不合格的影響程度相適應(yīng)。
A documented procedure shall be established to define requirements for
應(yīng)編制形成文件的程序，以規(guī)定以下方面的要求：
a) reviewing nonconformities (including customer complaints),
a) 評審不合格（包括顧客投訴）；
b) determining the causes of nonconformities ,
b) 確定不合格的原因；
c) evaluating the need for action to ensure that nonconformities do not recur,
c) 評價確保不合格不再發(fā)生的措施的需求；
d) determining and implementing action needed,
d) 確定和實施所需的措施；
e) records of the results of action taken (see 4.2.4), and
e) 記錄所采取措施的結(jié)果（見4.2.4）；
f) reviewing corrective action taken.
f) 評審所采取的糾正措施。
7.5.3 Preventive action
8.5.3 預防措施
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.
組織應(yīng)確定措施，以消除潛在不合格的原因，防止不合格的發(fā)生。預防措施應(yīng)與潛在問題的影響程度相適應(yīng)。
A documented procedure shall be established to define requirements for
應(yīng)編制形成文件的程序，以規(guī)定以下方面的要求：
a) determining potential nonconformities and their causes,
a) 確定潛在不合格及其原因；
b) evaluating the need for action to prevent occurrence of nonconformities,
b) 評價防止不合格發(fā)生的措施的需求；
c) determining and implementing action needed,
c) 確定并實施所需的措施；
d) records of results of action taken (see 4.2.4), and
d) 記錄所采取措施的結(jié)果（見4.2.4）；
e) reviewing preventive action taken.
e) 評審所采取的預防措施。
