ISO/DIS9001《質(zhì)量管理體系 要求》（2014國際標(biāo)準(zhǔn)草案）續(xù)
嘉峪檢測(cè)網(wǎng) 2015-08-30 16:36
8 Operation
運(yùn)作
8.1 Operational planning and control
運(yùn)作的策劃與控制
The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and to implement the actions determined in6.1, by:
組織應(yīng)依據(jù)4.4概述策劃、實(shí)施和控制滿足產(chǎn)品和服務(wù)提供的要求和實(shí)施6.1條款所確定的措施所需的過程，通過：
a) determining requirements for the product and services;
確定產(chǎn)品和服務(wù)的要求
b) establishing criteria for the processes and for the acceptance of products and services;
建立過程和產(chǎn)品和服務(wù)的接受準(zhǔn)則
c) determining the resources needed to achieve conformity to product and service requirements;
確定達(dá)到產(chǎn)品和服務(wù)要求所需的資源
d) implementing control of the processes in accordance with the criteria;
依據(jù)準(zhǔn)則實(shí)施對(duì)過程控制
e) retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements.
保持必要程度的文件信息，以確信過程已按照策劃和證明產(chǎn)品和服務(wù)符合的要求實(shí)施。
The output of this planning shall be suitable for the organization's operations.
策劃的輸出應(yīng)適用于組織的運(yùn)作
The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
組織應(yīng)控制計(jì)劃的變更和評(píng)審非預(yù)期的變更的后果，必要時(shí)，采取措施減輕任何不良影響。
The organization shall ensure that outsourced processes are controlled in accordance with 8.4.
組織應(yīng)確保外包過程是按照8.4控制
8.2 Determination of requirements for products and services
產(chǎn)品和服務(wù)的要求的確定
8.2.1 Customer communication
顧客溝通
The organization shall establish the processes for communicating with customers in relation to:
組織應(yīng)建立與顧客溝通的過程，關(guān)于：
a) information relating to products and services;
關(guān)于產(chǎn)品和服務(wù)的信息
b) enquiries, contracts or order handling, including changes;
問詢，合同或訂單的處理，包括對(duì)其的修訂
c) obtaining customer views and perceptions, including customer complaints;
獲取客戶的意見和看法，包括客戶抱怨
d) the handling or treatment of customer property, if applicable;
適用時(shí)，對(duì)顧客財(cái)產(chǎn)的處理
e) specific requirements for contingency actions, when relevant.
相關(guān)時(shí)，應(yīng)急措施的特定要求
8.2.2 Determination of requirements related to products and services
與產(chǎn)品和服務(wù)有關(guān)要求的確定
The organization shall establish, implement and maintain a process to determine the requirements for the products and services to be offered to potential customers.
組織應(yīng)建立、實(shí)施和保持一個(gè)過程來確定將提供給潛在顧客的產(chǎn)品和服務(wù)要求
The organization shall ensure that:
組織應(yīng)確保：
a) product and service requirements (including those considered necessary by the organization), and applicable statutory and regulatory requirements, are defined;
產(chǎn)品和服務(wù)要求（包括那些由組織認(rèn)為必要時(shí)）以及適用的法律法規(guī)要求是明確的
b) it has the ability to meet the defined requirements and substantiate the claims for the products and services it offers.
它有能力滿足規(guī)定的要求和證實(shí)其所提供的產(chǎn)品和服務(wù)的要求
8.2.3 Review of requirements related to products and services
與產(chǎn)品和服務(wù)有關(guān)要求的評(píng)審
The organization shall review, as applicable:
適用時(shí)，組織應(yīng)評(píng)審：
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;
由顧客規(guī)定的要求，包括交付及交付后的活動(dòng)要求；
b) requirements not stated by the customer, but necessary for the customers' specified or intended use, when known;
非顧客規(guī)定的要求，但已知的顧客規(guī)定的或預(yù)期的用途所必需的要求；
c) additional statutory and regulatory requirements applicable to the products and services;
適用于產(chǎn)品和服務(wù)的附加的法律法規(guī)的要求
d) contract or order requirements differing from those previously expressed.
與那些先前表述不一致的合同或訂單要求
NOTE Requirements can also include those arising from relevant interested parties.
注：也可包括來自相關(guān)方所產(chǎn)生的要求
This review shall be conducted prior to the organization’s commitment to supply products and services to the customer and shall ensure contract or order requirements differing from those previously defined are resolved.
評(píng)審應(yīng)在組織向顧客作出提供產(chǎn)品和服務(wù)的承諾之前進(jìn)行，并應(yīng)確保與那些先前確定不一致的合同或訂單的要求已得到解決。
Where the customer does not provide a documented statement of their requirements, the customer requirements shall be confirmed by the organization before acceptance.
若顧客沒有提供形成文件信息的要求，這些顧客的要求應(yīng)在組織接受前得到確認(rèn)。
Documented information describing the results of the review, including any new or changed requirements for the products and services, shall be retained.
描述評(píng)審結(jié)果的記錄信息，包括任何新的或變更的產(chǎn)品和服務(wù)的要求，應(yīng)該予以保留。
Where requirements for products and services are changed, the organization shall ensure that relevant documented information is amended and that relevant personnel are made aware of the changed requirements.
若產(chǎn)品和服務(wù)要求發(fā)生變更，組織應(yīng)確保相關(guān)記錄信息得到修改，并確保相關(guān)人員知道已變更的要求。
8.3 Design and development of products and services
產(chǎn)品和服務(wù)的設(shè)計(jì)和開發(fā)
8.3.1 General
總則
Where the detailed requirements of the organization’s products and services are not already established or not defined by the customer or by other interested parties, such that they are adequate for subsequent production or service provision, the organization shall establish, implement and maintain a design and process.
當(dāng)組織的產(chǎn)品和服務(wù)的詳細(xì)要求還沒有確定或未由顧客或其它相關(guān)方定義，以至使他們有足夠的后續(xù)生產(chǎn)和服務(wù)提供，組織應(yīng)建立、實(shí)施和保持一個(gè)設(shè)計(jì)和開發(fā)過程。
NOTE 1 The organization can also apply the requirements given in 8.5 to the development of processes for production and services provision
注1：組織也可將8.5的要求應(yīng)用于生產(chǎn)和服務(wù)提供過程的開發(fā)
NOTE 2 For services, design and development planning can address the whole service delivery process. The organization can therefore choose to consider the requirements of clauses 8.3 and 8.5 togther.
注2：針對(duì)服務(wù)而言，設(shè)計(jì)和開發(fā)的策劃可以針對(duì)整個(gè)服務(wù)交付過程，組織因此可以選擇考慮8.3和8.5條款在一起的要求
8.3.2 Design and development planning
設(shè)計(jì)和開發(fā)的策劃
In determining the stages and controls for design and development, the organization shall consider:
在確定設(shè)計(jì)和開發(fā)階段和控制時(shí)，組織應(yīng)考慮：
a) the nature, duration and complexity of the design and development activities;
設(shè)計(jì)和開發(fā)活動(dòng)的類型、持續(xù)時(shí)間和復(fù)雜性
b) requirements that specify particular process stages, including applicable design and development reviews;
指定特定的過程階段的要求，包括適用的設(shè)計(jì)和開發(fā)評(píng)審。
c) the required design and development verification and validation;
所需的設(shè)計(jì)和開發(fā)驗(yàn)證與確認(rèn)
d) the responsibilities and authorities involved in the design and development process;
參與設(shè)計(jì)和開發(fā)過程的職責(zé)和權(quán)限
e) the need to control interfaces between individuals and parties involved in the design and development process;
控制參與設(shè)計(jì)和開發(fā)過程的人員和團(tuán)體間的接口需求
f) the need for involvement of customer and user groups in the design and development process;
在設(shè)計(jì)和開發(fā)過程中需要參與的顧客和用戶組
g) the necessary documented information to confirm that design and development requirements have been met.
確認(rèn)設(shè)計(jì)和開發(fā)要求已得到滿足的必要的記錄信息。
8.3.3 Design and development Inputs
設(shè)計(jì)和開發(fā)輸入
The organization shall determine:
組織應(yīng)確定：
a) requirements essential for the specific type of products and services being designed and developed, including, as applicable, functional and performance requirements;
設(shè)計(jì)和開發(fā)的特定類型的產(chǎn)品和服務(wù)的基本要求，適用時(shí)，包括功能要求和性能要求。
b) applicable statutory and regulatory requirements;
適用的法律法規(guī)要求
c) standards or codes of practice that the organization has committed to implement;
組織一直致力于實(shí)施的行業(yè)法規(guī)和標(biāo)準(zhǔn)
d) internal and external resource needs for the design and development of products and services;
產(chǎn)品和服務(wù)的設(shè)計(jì)和開發(fā)所需的內(nèi)部資源和外部資源
e) the potential consequences of failure due to the nature of the products and services;
產(chǎn)品和服務(wù)的性質(zhì)引發(fā)的潛在的失效后果
f) the level of control expected of the design and development process by customers and other relevant interested parties.
顧客和其他相關(guān)方對(duì)設(shè)計(jì)和開發(fā)過程預(yù)期的控制水平
Inputs shall be adequate for design and development purposes, complete, and unambiguous.
輸入應(yīng)滿足設(shè)計(jì)和開發(fā)目的、完整和清楚
Conflicts among inputs shall be resolved.
輸入之間的矛盾應(yīng)當(dāng)解決
8.3.4 Design and development controls
設(shè)計(jì)和開發(fā)控制
The controls applied to the design and development process shall ensure that:
適用于設(shè)計(jì)和開發(fā)過程的控制應(yīng)確保：
a) the results to be achieved by the design and development activities are clearly defined;
通過設(shè)計(jì)和開發(fā)活動(dòng)要實(shí)現(xiàn)的結(jié)果有明確的規(guī)定
b) design and development reviews are conducted as planned;
依據(jù)策劃的安排對(duì)設(shè)計(jì)和開發(fā)進(jìn)行評(píng)審
c) verification is conducted to ensure that the design and development outputs have met the design and development input requirements;
實(shí)施驗(yàn)證，以確保設(shè)計(jì)和開發(fā)輸出已滿足設(shè)計(jì)和開發(fā)輸入的要求；
d) validation is conducted to ensure that the resulting products and services are capable of meeting the requirements for the specified application or intended use (when known).
實(shí)施確認(rèn)，以確保生成的產(chǎn)品和服務(wù)能夠滿足規(guī)定的使用要求或預(yù)期用途（當(dāng)已知）；
8.3.5 Design and development outputs
設(shè)計(jì)和開發(fā)輸出
The organization shall ensure that design and development outputs:
組織應(yīng)確保設(shè)計(jì)和開發(fā)輸出：
a) meet the input requirements for design and development;
滿足設(shè)計(jì)和開發(fā)的輸入要求
b) are adequate for the subsequent processes for the provision of products and services;
適合后續(xù)的產(chǎn)品和服務(wù)的提供過程
c) include or reference monitoring and measuring requirements, and acceptance criteria, as applicable;
適用時(shí)，包含或引用監(jiān)視和測(cè)量的要求和接受準(zhǔn)則；
d) ensure products to be produced, or services to be provided, are fit for intended purpose and their safe and proper use.
確保生產(chǎn)的產(chǎn)品，或者所提供的服務(wù)，符合預(yù)期的目的和產(chǎn)品和服務(wù)的安全和正常使用。
The organization shall retain the documented information resulting from the design and development process.
組織應(yīng)保留設(shè)計(jì)和開發(fā)過程中產(chǎn)生的文件信息
8.3.6 Design and development changes
設(shè)計(jì)和開發(fā)變更
The organization shall review, control and identify changes made to design inputs and design outputs during the design and development of products and services or subsequently, to the extent that there is no adverse impact on conformity to requirements.
組織應(yīng)評(píng)審、控制和識(shí)別在產(chǎn)品和服務(wù)的設(shè)計(jì)和開發(fā)過程中或隨后產(chǎn)生的設(shè)計(jì)輸入和設(shè)計(jì)輸出變更，某種程度上在符合要求方面沒有不良影響。
Documented information on design and development changes shall be retained.
設(shè)計(jì)和開發(fā)變更的信息應(yīng)予以保留
8.4 Control of externally provided products and services
產(chǎn)品和服務(wù)提供的外部控制
8.4.1 General
總則
The organization shall ensure that externally provided processes, products, and services conform to specified requirements.
組織應(yīng)確保外部提供的過程、產(chǎn)品和服務(wù)符合規(guī)定的要求。
The organization shall apply the specified requirements for the control of externally provided products and services when:
組織應(yīng)運(yùn)用為了控制外部提供的產(chǎn)品和服務(wù)的規(guī)定要求，當(dāng)：
a) products and services are provided by external providers for incorporation into the organization’s own products and services;
產(chǎn)品和服務(wù)是由外部供應(yīng)商提供構(gòu)成組織自身的產(chǎn)品和服務(wù)；
b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;
產(chǎn)品和服務(wù)直接由外部供應(yīng)商代表組織提供給客戶；
c) a process or part of a process is provided by an external provider as a result of a decision by the organization to outsource a process or function.
因由組織外包過程或功能的一個(gè)決定，由外部供應(yīng)商提供的一個(gè)過程或過程的一部分；
The organization shall establish and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers based on their ability to provide processes or products and services in accordance with specified requirements.
組織應(yīng)基于外部供應(yīng)商按照規(guī)定的要求提供過程或產(chǎn)品和服務(wù)的能力，建立和應(yīng)用對(duì)外部供應(yīng)商的評(píng)價(jià)、選擇、績效的監(jiān)視和重新評(píng)價(jià)的準(zhǔn)則。
The organization shall retain appropriate documented information of the results of the evaluations, monitoring of the performance and re-evaluations of the external providers.
組織應(yīng)保留外部供應(yīng)商的評(píng)價(jià)、績效的監(jiān)視和重新評(píng)價(jià)結(jié)果的適當(dāng)?shù)挠涗浶畔?br />
8.4.2 Type and extent of control of external provision
外部提供的控制的類型和程度
In determining the type and extent of controls to be applied to the external provision of processes, products and services, the organization shall take into consideration:
在確定適用于外部提供的過程、產(chǎn)品和服務(wù)的控制類型與程度時(shí)，組織應(yīng)考慮：
a) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements;
外部提供的過程、產(chǎn)品和服務(wù)關(guān)于組織持續(xù)滿足顧客和適用的法律法規(guī)要求的能力的潛在影響；
b) the perceived effectiveness of the controls applied by the external provider.
由外部提供所施加的控制的感知有效性。
The organization shall establish and implement verification or other activities necessary to ensure the externally provided processes, products and services do not adversely affect the organization's ability to consistently deliver conforming products and services to its customers.
組織應(yīng)建立并實(shí)施檢驗(yàn)或其他必要的活動(dòng)，以確保外部提供的過程、產(chǎn)品和服務(wù)，不影響組織穩(wěn)定提供給其顧客符合的產(chǎn)品和服務(wù)的能力。
Processes or functions of the organization which have been outsourced to an external provider remain within the scope of the organization’s quality management system; accordingly, the organization shall consider a) and b) above and define both the controls it intends to apply to the external provider and those it intends to apply to the resulting process output.
該組織已外包給外部供應(yīng)商的過程或功能保持在組織的質(zhì)量管理體系的范圍之內(nèi)，因此，組織應(yīng)考慮以上a）和b）項(xiàng)，同時(shí)確定兩種控制：它打算申請(qǐng)外部供應(yīng)商和它打算申請(qǐng)過程輸出結(jié)果。
8.4.3 Information for external providers
外部供應(yīng)商的信息
The organization shall communicate to external providers applicable requirements for the following:
組織應(yīng)與外部供應(yīng)商溝通如下適用的要求：
a) the products and services to be provided or the processes to be performed on behalf of the organization;
提供的產(chǎn)品和服務(wù)或代表組織實(shí)施的過程
b) Approval or release of products and services, methods, processes or equipment;
產(chǎn)品和服務(wù)、方法、過程或設(shè)備的放行或批準(zhǔn)
c) competence of personnel, including necessary qualification;
人員的能力，包含必要的資格
d) their interactions with the organization's quality management system;
他們與組織質(zhì)量管理體系之間的相互作用
e) the control and monitoring of the external provider’s performance to be applied by the organization;
由組織施加的對(duì)外部供應(yīng)商的業(yè)績的控制和監(jiān)視
f) verification activities that the organization, or its customer, intends to perform at the external provider’s premises.
組織或其顧客，擬在外部供應(yīng)商現(xiàn)場(chǎng)實(shí)施的驗(yàn)證活動(dòng)
The organization shall ensure the adequacy of specified requirements prior to their communication to the external provider.
在與外部供應(yīng)商溝通前，組織應(yīng)確保所規(guī)定的要求是充分的
8.5 Production and service provision
產(chǎn)品和服務(wù)提供
8.5.1 Control of production and service provision
產(chǎn)品和服務(wù)提供的控制
The organization shall implement controlled conditions for production and service provision, including delivery and post-delivery activities.
組織應(yīng)在受控條件下實(shí)施產(chǎn)品和服務(wù)提供，包括交付和交付后的活動(dòng)
Controlled conditions shall include, as applicable:
適用時(shí)，受控條件應(yīng)包括：
a) the availability of documented information that defines the characteristics of the products and services;
表述產(chǎn)品和服務(wù)特性的記錄信息的可用性
b) the availability of documented information that defines the activities to be performed and the results to be achieved;
獲得表述實(shí)施的活動(dòng)及其實(shí)施結(jié)果的記錄信息
c) monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met.
在適當(dāng)階段監(jiān)視和測(cè)量活動(dòng)證實(shí)已滿足過程和過程輸出的控制準(zhǔn)則，及產(chǎn)品和服務(wù)的接受準(zhǔn)則；
d) the use, and control of suitable infrastructure and process environment;
使用、并控制適宜的基礎(chǔ)設(shè)施和過程環(huán)境；
e) the availability and use of suitable monitoring and measuring resources;
獲得和使用適宜的測(cè)量和監(jiān)視資源；
f) the competence and, where applicable, required qualification of persons;
適用情況下，人員的能力和所需的資格
g) the validation, and periodic revalidation, of the ability to achieve planned results of any process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement;
當(dāng)結(jié)果的輸出不能通過后續(xù)的監(jiān)視和測(cè)量加以驗(yàn)證時(shí)，對(duì)實(shí)現(xiàn)所策劃的任何產(chǎn)品和服務(wù)提供過程的結(jié)果能力的確認(rèn)和重新確認(rèn)
h) the implementation of products and services release, delivery and post-delivery activities.
產(chǎn)品和服務(wù)的放行，交付和交付后活動(dòng)的實(shí)施。
8.5.2 Identification and traceability
標(biāo)識(shí)和可追溯性
Where necessary to ensure conformity of products and services, the organization shall use suitable means to identify process outputs.
當(dāng)必須確保產(chǎn)品和服務(wù)的符合性，組織應(yīng)使用適宜的方法識(shí)別過程輸出。
The organization shall identify the status of process outputs with respect to monitoring and measurement requirements throughout production and service provision.
組織應(yīng)在產(chǎn)品和服務(wù)提供的全過程中相對(duì)于監(jiān)視和測(cè)量要求識(shí)別過程輸出的狀態(tài)。
Where traceability is a requirement, the organization shall control the unique identification of the process outputs, and retain any documented information necessary to maintain traceability.
在有可追溯性要求的場(chǎng)合，組織應(yīng)控制過程輸出的唯一性標(biāo)識(shí)，并保留所有必需的保持可追溯性的記錄信息。
NOTE Process outputs are the results of any activities which are ready for delivery to the organization’s customer or to an internal customer (e.g. receiver of the inputs to the next process); they can include products, services, intermediate parts, components, etc.
注：過程輸出是任何活動(dòng)的結(jié)果，它將交付給組織的顧客或內(nèi)部顧客（例如，下一個(gè)過程輸入的接受者）；他們可以包括產(chǎn)品、服務(wù)、中間件、零部件等。
8.5.3 Property belonging to customers or external providers
顧客或外部供應(yīng)商的財(cái)產(chǎn)
The organization shall exercise care with property belonging to the customer or external providers while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard the customer’s or external provider’s property provided for use or incorporation into the products and services.
組織應(yīng)愛護(hù)在組織控制下或由組織使用的屬于顧客或外部供應(yīng)商的財(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)品和服務(wù)的顧客或外部供應(yīng)商的財(cái)產(chǎn)。
When property of the customer or external provider is incorrectly used, lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider.
當(dāng)顧客或外部供應(yīng)商的財(cái)產(chǎn)被錯(cuò)誤使用、丟失、損壞或發(fā)現(xiàn)不適用時(shí)，組織應(yīng)向顧客或外部供應(yīng)商報(bào)告。
NOTE Customer property can include material, components, tools and equipment, customer premises, intellectual property and personal data.
注：顧客財(cái)產(chǎn)可以包括：材料、零部件、工具或設(shè)備、顧客設(shè)施、知識(shí)產(chǎn)權(quán)和私人信息。
8.5.4 Preservation
產(chǎn)品防護(hù)
The organization shall ensure preservation of process outputs during production and service provision, to the extent necessary to maintain conformity to requirements.
組織應(yīng)確保在產(chǎn)品和服務(wù)提供過程中過程輸出的防護(hù)，在一定程度上必需保持符合要求。
NOTE Preservation can include identification, handling, packaging, storage, transmission or transportation, and protection.
注：防護(hù)可以包括：標(biāo)識(shí)、搬運(yùn)、包裝、貯存、傳輸或運(yùn)輸、和保護(hù)。
8.5.5 Post-delivery activities
交付后的活動(dòng)
As applicable, the organization shall meet requirements for post-delivery activities associated with the products and services.
適用時(shí)，組織應(yīng)滿足與產(chǎn)品和服務(wù)相關(guān)的交付后的活動(dòng)要求
In determining the extent of post-delivery activities that are required, the organization shall consider:
在確定被要求的交付后活動(dòng)所需的程度，組織應(yīng)考慮：
a) the risks associated with the products and services;
與產(chǎn)品和服務(wù)相關(guān)的風(fēng)險(xiǎn)
b) the nature, use and intended lifetime of the products and services;
產(chǎn)品和服務(wù)的性質(zhì)、用途和預(yù)期壽命
c) customer feedback;
顧客反饋
d) statutory and regulatory requirements.
法律法規(guī)要求
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.
注：交付后的活動(dòng)可以包括：保修條款的措施、諸如維護(hù)服務(wù)的合同義務(wù)，及諸如回收或最終處置等附加服務(wù)
8.5.6 Control of changes
變更控制
The organization shall review and control unplanned changes essential for production or service provision to the extent necessary to ensure continuing conformity with specified requirements.
組織應(yīng)評(píng)審和控制用于產(chǎn)品或服務(wù)提供必要的非計(jì)劃的變更，確保持續(xù)滿足規(guī)定的要求
The organization shall retain documented information describing the results of the review of changes, the personnel authorizing the change, and any necessary actions.
組織應(yīng)將變更的評(píng)審結(jié)果、變更的人員授權(quán)、和任何必要的措施的記錄信息予以保留
8.6 Release of products and services
產(chǎn)品和服務(wù)的放行
The organization shall implement the planned arrangements at appropriate stages to verify that product and service requirements have been met. Evidence of conformity with the acceptance criteria shall be retained.
組織應(yīng)在適當(dāng)?shù)碾A段實(shí)施策劃的安排，以驗(yàn)證產(chǎn)品和服務(wù)要求已得到滿足，符合接受準(zhǔn)則的證據(jù)應(yīng)予以保留。
The release of products and services to the customer shall not proceed until the planned arrangements for verification of conformity have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. Documented information shall provide traceability to the person(s) authorizing release of products and services for delivery to the customer.
除非得到有關(guān)授權(quán)人員的批準(zhǔn)，和適用時(shí)得到顧客的批準(zhǔn)，否則在策劃的符合性驗(yàn)證安排已圓滿完成之前，不應(yīng)向顧客進(jìn)行產(chǎn)品和服務(wù)的放行。記錄信息應(yīng)提供可追溯的授權(quán)放行產(chǎn)品和服務(wù)以交付給顧客的人員。
8.7 Control of nonconforming process outputs, products and services
不合格的過程輸出、產(chǎn)品和服務(wù)的控制
The organization shall ensure process outputs, products and services that do not conform to requirements are identified and controlled to prevent their unintended use or delivery.
組織應(yīng)確保對(duì)不符合要求的過程輸出、產(chǎn)品和服務(wù)得到識(shí)別和控制，以防止它們的非預(yù)期使用或交付。
The organization shall take appropriate corrective action based on the nature of the nonconformity and its impact on the conformity of products and services. This applies also to nonconforming products and services detected after delivery of the products or during the provision of the service.
組織應(yīng)基于對(duì)產(chǎn)品和服務(wù)符合性的不符合性質(zhì)及其影響采取適當(dāng)?shù)募m正措施，這也適用于在產(chǎn)品交付后或服務(wù)提供過程中發(fā)生的不合格產(chǎn)品和服務(wù)的處置。
As applicable, the organization shall deal with nonconforming process outputs, products and services in one or more of the following ways:
適用時(shí)，組織應(yīng)用以下一種或多種方法處置不合格的過程輸出、產(chǎn)品和服務(wù)
a) correction;
糾正
b) segregation, containment, return or suspension of provision of products and services;
隔離、控制、召回或暫停產(chǎn)品和服務(wù)的提供
c) informing the customer;
通知顧客
d) obtaining authorization for:
獲得以下授權(quán)：
??use “as-is’;
免責(zé)使用
??release, continuation or re-provision of the products and services;
放行、繼續(xù)使用或重新提供產(chǎn)品和服務(wù)
??acceptance under concession.
讓步接受
Where nonconforming process outputs, products and services are corrected, conformity to the requirements shall be verified.
在不合格的過程輸出、產(chǎn)品和服務(wù)得到糾正之后，應(yīng)對(duì)其要求的符合性進(jìn)行驗(yàn)證。
The organization shall retain documented information of actions taken on nonconforming process outputs, products and services, including on any concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformity.
組織應(yīng)保留有關(guān)不合格的過程輸出、產(chǎn)品和服務(wù)已采取措施的記錄信息，包括獲取的任何讓步、作出處置不合格決定的人或機(jī)構(gòu)。
京公網(wǎng)安備11010802046783號(hào)
