d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
d) 為實(shí)現(xiàn)過(guò)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(yùn)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(duì)應(yīng)用于特定產(chǎn)品、項(xiàng)目或合同的質(zhì)量管理體系的過(guò)程（包括產(chǎn)品實(shí)現(xiàn)過(guò)程）和資源作出規(guī)定的文件可稱之為質(zhì)量計(jì)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(shí)現(xiàn)過(guò)程的開(kāi)發(fā)。
6.2 Customer-related processes
7.2 與顧客有關(guān)的過(guò)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(duì)交付及交付后活動(dòng)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(méi)有明示，但規(guī)定的用途或已知的預(yù)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(píng)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(píng)審與產(chǎn)品有關(guān)的要求。評(píng)審應(yīng)在組織向顧客作出提供產(chǎn)品的承諾之前進(jìn)行（如：提交標(biāo)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(píng)審結(jié)果及評(píng)審所引起的措施的記錄應(yīng)予保持（見(jiàn)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(méi)有形成文件，組織在接收顧客要求前應(yīng)對(duì)顧客要求 進(jìn)行確認(rèn)。
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(duì)每一個(gè)訂單進(jìn)行正式的評(píng)審可能是不實(shí)際的。而代之對(duì)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(jìn)行評(píng)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(duì)以下有關(guān)方面確定并實(shí)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(wèn)詢、合同或訂單的處理，包括對(duì)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(jì)和開(kāi)發(fā)
6.3.1 Design and development planning
7.3.1 設(shè)計(jì)和開(kāi)發(fā)策劃
The organization shall plan and control the design and development of product.
組織應(yīng)對(duì)產(chǎn)品的設(shè)計(jì)和開(kāi)發(fā)進(jìn)行策劃和控制。
During the design and development planning, the organization shall determine
在進(jìn)行設(shè)計(jì)和開(kāi)發(fā)策劃時(shí)，組織應(yīng)確定：
a) the design and development stages,
a) 設(shè)計(jì)和開(kāi)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(gè)設(shè)計(jì)和開(kāi)發(fā)階段的評(píng)審、驗(yàn)證和確認(rèn)活動(dòng)；
c) the responsibilities and authorities for design and development.
c) 設(shè)計(jì)和開(kāi)發(fā)的職責(zé)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(duì)參與設(shè)計(jì)和開(kāi)發(fā)的不同小組之間的接口實(shí)施管理，以確保有效的溝通，并明確職責(zé)分工。
Planning output shall be updated, as appropriate, as the design and development progresses.
隨設(shè)計(jì)和開(kāi)發(fā)的進(jìn)展，在適當(dāng)時(shí)，策劃的輸出予以更新。
6.3.2 Design and development inputs
7.3.2 設(shè)計(jì)和開(kāi)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(jiàn)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(shí)，以前類似設(shè)計(jì)提供的信息
d) other requirements essential for design and development.
d) 設(shè)計(jì)和開(kāi)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(duì)這些輸入進(jìn)行評(píng)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(jì)和開(kāi)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(jì)和開(kāi)發(fā)的輸出應(yīng)以能夠針對(duì)設(shè)計(jì)和開(kāi)發(fā)的輸入進(jìn)行驗(yàn)證的方式提出，并應(yīng)在放行前得到批準(zhǔn)。
Design and development outputs shall
設(shè)計(jì)和開(kāi)發(fā)輸出應(yīng)：
a) meet the input requirements for design and development,
a) 滿足設(shè)計(jì)和開(kāi)發(fā)輸入的要求；
b) provide appropriate information for purchasing, production and for service provision,
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c) contain or reference product acceptance criteria, and
c) 包含或引用產(chǎn)品接收準(zhǔn)則；
d) specify the characteristics of the product that are essential for its safe and proper use.
d) 規(guī)定對(duì)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(jì)和開(kāi)發(fā)評(píng)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(duì)依據(jù)所策劃的安排（見(jiàn)7.3.1）設(shè)計(jì)和開(kāi)發(fā)進(jìn)行系統(tǒng)的評(píng)審，以便：
a) to evaluate the ability of the results of design and development to meet requirements, and
a) 評(píng)價(jià)設(shè)計(jì)和開(kāi)發(fā)的結(jié)果滿足要求的能力；
b) to identify any problems and propose necessary actions.
b) 識(shí)別任何問(wèn)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(píng)審的參加者應(yīng)包括與所評(píng)審的設(shè)計(jì)和開(kāi)發(fā)階段有關(guān)的職能的代表，評(píng)審結(jié)果及任何必要措施的記錄應(yīng)予保持（見(jiàn)4.2.4）。
6.3.5 Design and development verification
7.3.5 設(shè)計(jì)和開(kāi)發(fā)驗(yàn)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(jì)和開(kāi)發(fā)輸出滿足輸入的要求，應(yīng)對(duì)依據(jù)所策劃的安排（見(jiàn)7.3.1）設(shè)計(jì)和開(kāi)發(fā)進(jìn)行驗(yàn)證。驗(yàn)證結(jié)果及任何必要措施的記錄應(yīng)予保持（見(jiàn)4.2.4）。
6.3.6 Design and development validation
7.3.6 設(shè)計(jì)和開(kāi)發(fā)確認(rèn)
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(yù)期用途的要求，應(yīng)依據(jù)所策劃的安排（見(jiàn)7.3.1）對(duì)設(shè)計(jì)和開(kāi)發(fā)進(jìn)行確認(rèn)。只要可行，確認(rèn)應(yīng)在產(chǎn)品交付或?qū)嵤┲巴瓿伞４_認(rèn)結(jié)果及任何必要措施的記錄應(yīng)予保持（見(jiàn)4.2.4）。
6.3.7 Control of design and development changes
7.3.7 設(shè)計(jì)和開(kāi)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(shí)別設(shè)計(jì)和開(kāi)發(fā)的更改，并保持記錄，在適當(dāng)時(shí)，應(yīng)對(duì)設(shè)計(jì)和開(kāi)發(fā)的更改進(jìn)行評(píng)審、驗(yàn)證和確認(rèn)，并在實(shí)施前得到批準(zhǔn)，設(shè)計(jì)和開(kāi)發(fā)更改的評(píng)審應(yīng)包括評(píng)價(jià)更改對(duì)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(píng)審結(jié)果及任何必要措施的記錄應(yīng)予保持（見(jiàn)4.2.4）。
6.4 Purchasing
7.4 采購(gòu)
6.4.1 Purchasing process
7.4.1 采購(gòu)過(guò)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(gòu)的產(chǎn)品符合規(guī)定的采購(gòu)要求，對(duì)供方及采購(gòu)的產(chǎn)品控制的類型和程度應(yīng)取決于采購(gòu)的產(chǎn)品對(duì)隨后的產(chǎn)品實(shí)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(píng)價(jià)和選擇供方應(yīng)制定選擇、評(píng)價(jià)和重新評(píng)價(jià)的準(zhǔn)則。評(píng)價(jià)結(jié)果及評(píng)價(jià)所引起的任何必要措施的記錄應(yīng)予保持（見(jiàn)4.2.4）。
6.4.2 Purchasing information
7.4.2 采購(gòu)信息
Purchasing information shall describe the product to be purchased, including where appropriate
采購(gòu)信息應(yīng)表述擬采購(gòu)的產(chǎn)品，適當(dāng)時(shí)包括：
a) requirements for approval of product, procedures, processes and equipment,
a) 產(chǎn)品、程序、過(guò)程和設(shè)備批準(zhǔn)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(gòu)要求是充分與適宜的。
6.4.3 Verification of purchased product
7.4.3 采購(gòu)產(chǎn)品的驗(yàn)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(shí)施檢驗(yàn)或其他必要的活動(dòng)，以確保采購(gòu)的產(chǎn)品滿足規(guī)定的采購(gòu)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(dāng)組織或其顧客擬在供方的現(xiàn)場(chǎng)實(shí)施驗(yàn)證時(shí)，組織應(yīng)在采購(gòu)信息中對(duì)擬驗(yàn)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(jìn)行生產(chǎn)和服務(wù)提供，適用時(shí)，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(dǎo)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(cè)量裝置；
e) the implementation of monitoring and measurement, and
e) 實(shí)施監(jiān)視和測(cè)量；
f) the implementation of release, delivery and post-delivery activities.
f) 放行、交付和交付后活動(dòng)的實(shí)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(guò)程的確認(rèn)
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(dāng)生產(chǎn)和服務(wù)提供過(guò)程的輸出不能由后續(xù)的監(jiān)視或測(cè)量加以驗(yàn)證時(shí)，組織應(yīng)對(duì)任何這樣的過(guò)程實(shí)施確認(rèn)。這包括僅在產(chǎn)品使用或服務(wù)已交付之后問(wèn)題才顯現(xiàn)的過(guò)程。
Validation shall demonstrate the ability of these processes to achieve planned results.
確認(rèn)應(yīng)證實(shí)這些過(guò)程實(shí)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(rèn)這些過(guò)程的安排，適用時(shí)包括：
a) defined criteria for review and approval of the processes,
a) 為過(guò)程的評(píng)審和批準(zhǔn)所規(guī)定的準(zhǔn)則；
b) approval of equipment and qualification of personnel,
b) 設(shè)備的認(rèn)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(jiàn)4.2.4）；
e) revalidation.
e) 再確認(rèn)。
6.5.3 Identification and traceability
7.5.3 標(biāo)識(shí)和可追溯性
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
適當(dāng)時(shí)，組織應(yīng)在產(chǎn)品實(shí)現(xiàn)的全過(guò)程中使用適宜的方法識(shí)別產(chǎn)品
The organization shall identify the product status with respect to monitoring and measurement requirements.
組織應(yīng)針對(duì)監(jiān)視和測(cè)量要求識(shí)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(chǎng)合，組織應(yīng)控制并記錄產(chǎn)品的唯一性標(biāo)識(shí)（見(jiàn)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(biāo)識(shí)和可追溯性的一種方法。
6.5.4 Customer property
7.5.4 顧客財(cái)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(ài)護(hù)在組織控制下或組織使用的顧客財(cái)產(chǎn)。組織應(yīng)識(shí)別、驗(yàn)證、保護(hù)和維護(hù)供其使用或構(gòu)成產(chǎn)品一部分的顧客財(cái)產(chǎn)。若顧客財(cái)產(chǎn)發(fā)生丟失、損壞或發(fā)現(xiàn)不適用的情況時(shí)，應(yīng)報(bào)告顧客，并保持記錄（見(jiàn)4.2.4）。
NOTE Customer property can include intellectual property.
注：顧客財(cái)產(chǎn)可包括知識(shí)產(chǎn)權(quán)。
6.5.5 Preservation of product
7.5.5 產(chǎn)品防護(hù)
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(yù)定的地點(diǎn)其間，組織應(yīng)針對(duì)產(chǎn)品的符合性提供防護(hù)，這種防護(hù)應(yīng)包括標(biāo)識(shí)、搬運(yùn)、包裝、貯存和保護(hù)。防護(hù)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(cè)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(shí)施的監(jiān)視和測(cè)量以及所需的監(jiān)視和測(cè)量裝置，提供證據(jù)，為產(chǎn)品符合確定的要求（見(jiàn)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(guò)程，以確保監(jiān)視和測(cè)量活動(dòng)可行并以與監(jiān)視和測(cè)量的要求相一致的方式實(shí)施。
Where necessary to ensure valid results, measuring equipment shall
當(dāng)有必要確保結(jié)果有效的場(chǎng)合時(shí)，測(cè)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(duì)照能溯源到國(guó)際或國(guó)家標(biāo)準(zhǔn)的測(cè)量標(biāo)準(zhǔn)，按照規(guī)定的時(shí)間間隔或在使用前進(jìn)行校準(zhǔn)或檢定。當(dāng)不存在上述標(biāo)準(zhǔn)時(shí)，應(yīng)記錄校準(zhǔn)或檢定的依據(jù)；
b) be adjusted or re-adjusted as necessary;
b) 必要時(shí)進(jìn)行調(diào)整或再調(diào)整；
c) be identified to enable the calibration status to be determined;
c) 得到識(shí)別，以確定其校準(zhǔn)狀態(tài)；
d) be safeguarded from adjustments that would invalidate the measurement result;
d) 防止可能使測(cè)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(yùn)、維護(hù)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(dāng)發(fā)現(xiàn)設(shè)備不符合要求時(shí)，組織應(yīng)對(duì)以往測(cè)量結(jié)果的有效性進(jìn)行評(píng)價(jià)和記錄。組織應(yīng)對(duì)該設(shè)備和任何受影響的產(chǎn)品采取適當(dāng)?shù)拇胧Ｐ?zhǔn)和驗(yàn)證結(jié)果的記錄應(yīng)予保持（見(jiàn)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(dāng)用于規(guī)定要求的監(jiān)視和測(cè)量時(shí)，計(jì)算機(jī)軟年滿足預(yù)期用途的能力應(yīng)予以確認(rèn)，確認(rèn)應(yīng)在初次使用前進(jìn)行，并在必要時(shí)予以重新確認(rèn)。
NOTE See ISO 10012-1 and ISO 10012-2 for guidance.
注：作為指南，參見(jiàn)ISO 10012-1和ISO 10012-2。
7 Measurement, analysis and improvement
8 測(cè)量、分析和改進(jìn)
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(shí)施以下方面所需的監(jiān)視、測(cè)量、分析和改進(jìn)過(guò)程：
a) to demonstrate conformity of the product,
a) 證實(shí)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(jìn)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(duì)統(tǒng)計(jì)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(cè)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(duì)質(zhì)量管理體系業(yè)績(jī)的一種測(cè)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(shí)間間隔進(jìn)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(jiàn)7.1）、本標(biāo)準(zhǔn)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(shí)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(guò)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(duì)審核方案進(jìn)行策劃。應(yīng)規(guī)定審核的準(zhǔn)則、范圍、頻次和方法。審核員的選擇和審核的實(shí)施應(yīng)確保審核過(guò)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(shí)施審核以及報(bào)告結(jié)果和保持記錄（見(jiàn)4.2.4）的職責(zé)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(fù)責(zé)受審區(qū)域的管理者應(yīng)確保及時(shí)采取措施，以消除向發(fā)現(xiàn)和不合格及其原因。跟蹤活動(dòng)應(yīng)包括對(duì)所采取措施的驗(yàn)證和驗(yàn)證結(jié)果的報(bào)告（見(jiàn)8.5.2）。
NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
注：作為指南，參見(jiàn)ISO 10011-1, ISO 10011-2 和 ISO 10011-3。
7.2.3 Monitoring and measurement of processes
8.2.3 過(guò)程的監(jiān)視和測(cè)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(duì)質(zhì)量管理體系過(guò)程進(jìn)行監(jiān)視，并在適用時(shí)進(jìn)行測(cè)量。這些方法應(yīng)證實(shí)過(guò)程實(shí)現(xiàn)所策劃的結(jié)果的能力。當(dāng)未能達(dá)到所策劃的結(jié)果時(shí)，應(yīng)采取適當(dāng)?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(cè)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(duì)產(chǎn)品的特性進(jìn)行監(jiān)視和測(cè)量，以驗(yàn)證產(chǎn)品要求已得到滿足。這種監(jiān)視和測(cè)量應(yīng)依據(jù)所策劃的安排（見(jiàn)7.1），在產(chǎn)品實(shí)現(xiàn)過(guò)程的適當(dāng)階段進(jìn)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(zhǔn)則的證據(jù)。記錄應(yīng)指明有權(quán)放行產(chǎn)品的人員（見(jiàn)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(zhǔn)，適用時(shí)得到顧客的批準(zhǔn)，否則在策劃的安排（見(jiàn)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(shí)別和控制，以防止其非預(yù)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(zé)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(guò)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(zhǔn)，適用時(shí)經(jīng)顧客批準(zhǔn)，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(yù)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(zhǔn)的讓步的記錄（見(jiàn)4.2.4）。
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
應(yīng)對(duì)糾正后的產(chǎn)品再次進(jìn)行驗(yàn)證，以證實(shí)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(dāng)在交付或開(kāi)始使用后發(fā)現(xiàn)產(chǎn)品不合格時(shí)，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(dāng)?shù)臄?shù)據(jù)，以證實(shí)質(zhì)量管理體系的適宜性和有效性，并評(píng)價(jià)在何處可以持續(xù)改進(jìn)質(zhì)量管理體系的有效性。這應(yīng)包括來(lái)自監(jiān)視和測(cè)量的結(jié)果以及其他有關(guān)來(lái)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(jiàn)8.2.1）；
b) conformity to product requirements (see 7.2.1),
b) 與產(chǎn)品要求的符合性（見(jiàn)7.2.1）；
c) characteristics and trends of processes and products including opportunities for preventive action, and
c) 過(guò)程和產(chǎn)品的特性趨勢(shì)，包括采取預(yù)防措施的機(jī)會(huì)；
d) suppliers.
d) 供方。
7.5 Improvement
8.5 改進(jìn)
7.5.1 Continual improvement
8.5.1 持續(xù)改進(jìn)
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(biāo)、審核結(jié)果、數(shù)據(jù)分析、糾正和預(yù)防措施以及管理評(píng)審，持續(xù)改進(jìn)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(píng)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(píng)價(jià)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(shí)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(jiàn)4.2.4）；
f) reviewing corrective action taken.
f) 評(píng)審所采取的糾正措施。
7.5.3 Preventive action
8.5.3 預(yù)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(yù)防措施應(yīng)與潛在問(wèn)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(píng)價(jià)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(shí)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(jiàn)4.2.4）；
e) reviewing preventive action taken.
e) 評(píng)審所采取的預(yù)防措施。
