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    4.3 Determining the scope of the quality management system確定質(zhì)量管理體系的范圍
    The organization shall determine the boundaries and applicability of the quality management system
    to establish its scope.
    When determining this scope, the organization shall consider:
    a) the external and internal issues referred to in 4.1;
    b) the requirements of relevant interested parties referred to in 4.2;
    c) the products and services of the organization.
    The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
    The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
    Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
    組織應(yīng)確定質(zhì)量管理體系的邊界和適用性來建立其范圍。
    在確定質(zhì)量管理體系范圍時,組織應(yīng)考慮:
    a) 在4.1中涉及的外部和內(nèi)部情況;
    b) 在4.2中涉及的有關(guān)相關(guān)方要求;
    c) 組織的產(chǎn)品與服務(wù)。
    如本標(biāo)準(zhǔn)的要求在確定的范圍內(nèi)適用,組織應(yīng)應(yīng)用本標(biāo)準(zhǔn)的所有要求。 組織的質(zhì)量管理體系范圍應(yīng)可獲取并保持形成文件的信息。范圍應(yīng)說明質(zhì)量管理體系所覆蓋的產(chǎn)品和服務(wù),并對組織確定不適用于管理體系范圍的本標(biāo)準(zhǔn)的要求說明正當(dāng)理由。
    當(dāng)被確定為不適用的要求不影響組織確保產(chǎn)品和服務(wù)的符合性以及增強(qiáng)顧客滿意的能力或責(zé)任時,才能聲稱符合本標(biāo)準(zhǔn)的要求。
    4.4 Quality management system and its processes質(zhì)量管理體系及其過程
    4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
    The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
    a) determine the inputs required and the outputs expected from these processes;
    b) determine the sequence and interaction of these processes;
    c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
    d) determine the resources needed for these processes and ensure their availability;
    e) assign the responsibilities and authorities for these processes;
    f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
    g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
    h) improve the processes and the quality management system.
    4.4.1 組織應(yīng)按本標(biāo)準(zhǔn)的要求建立、實施、保持和持續(xù)改進(jìn)質(zhì)量管理體系,包括質(zhì)量管理體系所需的過程及其相互作用。
    組織應(yīng)確定質(zhì)量管理體系所需的過程及其在整個組織中的應(yīng)用,組織應(yīng):
    a) 確定這些過程所需的輸入和期望的輸出;
    b) 確定這些過程的順序和相互作用;
    c) 確定和應(yīng)用所需的準(zhǔn)則和方法(包括監(jiān)視、測量和相關(guān)的績效指標(biāo)),以確保這些過程的有效運(yùn)行和控制;
    d) 確定這些過程所需的資源并確保其可用性;
    e) 規(guī)定這些過程的職責(zé)和權(quán)限;
    f) 應(yīng)對按照6.1的要求確定的風(fēng)險和機(jī)會;
    g) 評價這些過程并實施所需的變更,以確保這些過程實現(xiàn)預(yù)期的結(jié)果;
    h) 改進(jìn)過程和質(zhì)量管理體系。
    4.4.2 To the extent necessary, the organization shall:
    a) maintain documented information to support the operation of its processes;
    b) retain documented information to have confidence that the processes are being carried out as planned.
    4.4.2 組織應(yīng)保持必要程度的:
    a) 保持形成文件的信息,為過程運(yùn)行提供支持;
    b) 保留形成文件的信息,以證實過程是按策劃執(zhí)行的。
    5 Leadership 領(lǐng)導(dǎo)力
    5.1 Leadership and commitment 領(lǐng)導(dǎo)力和承諾
    5.1.1 General 總則
    Top management shall demonstrate leadership and commitment with respect to the quality management system by:
    a) taking accountability for the effectiveness of the quality management system;
    b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;
    c) ensuring the integration of the quality management system requirements into the organization’s business processes;
    d) promoting the use of the process approach and risk-based thinking;
    e) ensuring that the resources needed for the quality management system are available;
    f) communicating the importance of effective quality management and of conforming to the quality management system requirements;
    g) ensuring that the quality management system achieves its intended results;
    h) engaging, directing and supporting persons to contribute to the effectiveness of the quality
    management system;
    i) promoting improvement;
    j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
    NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.
    最高管理者應(yīng)通過以下方面證實其領(lǐng)導(dǎo)力和對質(zhì)量管理體系承諾:
    a) 對質(zhì)量管理體系的有效性承擔(dān)責(zé)任;
    b) 確保質(zhì)量方針和質(zhì)量目標(biāo)得到建立,并與組織的戰(zhàn)略方向和組織環(huán)境保持一致;
    組織規(guī)定的要求;
    d) 適用于產(chǎn)品和服務(wù)的法律法規(guī)要求;
    e) 與以前表述不一致的合同或訂單的要求。
    組織應(yīng)確保與以前規(guī)定不一致的合同或訂單要求已得到解決。
    顧客沒有提供其要求的文件化說明時,組織應(yīng)在接受前對顧客要求進(jìn)行確認(rèn)。
    注:在某些情況下,如網(wǎng)絡(luò)銷售,對每一個訂單進(jìn)行正式的評審可能是不實際的。作為替代方法,可對提供給顧客的有關(guān)的產(chǎn)品信息進(jìn)行評審,如產(chǎn)品目錄。
    8.2.3.2 The organization shall retain documented information, as applicable:
    a) on the results of the review;
    b) on any new requirements for the products and services.
    8.2.3.2 適用時,組織應(yīng)保留以下方面的形成文件的信息:
    a) 評審結(jié)果;
    b) 產(chǎn)品和服務(wù)的任何新要求。
    8.2.4 Change to requirements for products and service 產(chǎn)品和服務(wù)要求的變更
    The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.
    若產(chǎn)品和服務(wù)要求發(fā)生變更,組織應(yīng)確保相關(guān)的形成文件的信息得到修改,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)計和開發(fā)
    8.3.1 General 總則
    The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.
    組織應(yīng)建立、實施和維護(hù)設(shè)計和開發(fā)過程,以適用于確保后續(xù)的產(chǎn)品和服務(wù)的提供。
    8.3.2 Design and development planning 設(shè)計和開發(fā)策劃
    In determining the stages and controls for design and development, the organization shall consider:
    a) the nature, duration and complexity of the design and development activities;
    b) the required process stages, including applicable design and development reviews;
    c) the required design and development verification and validation activities;
    d) the responsibilities and authorities involved in the design and development process;
    e) the internal and external resource needs for the design and development of products and services;
    f) the need to control interfaces between persons involved in the design and development process;
    g) the need for involvement of customers and users in the design and development process;
    h) the requirements for subsequent provision of products and services;
    i) the level of control expected for the design and development process by customers and other
    relevant interested parties;
    j) the documented information needed to demonstrate that design and development requirements have been met.
    在確定設(shè)計和開發(fā)的階段和控制時,組織應(yīng)考慮:
    a) 設(shè)計和開發(fā)活動的性質(zhì)、持續(xù)時間和復(fù)雜性;
    b) 所需的過程階段,包括適用的設(shè)計和開發(fā)評審;
    c) 所需的設(shè)計和開發(fā)的驗證和確認(rèn);
    d) 設(shè)計和開發(fā)過程涉及的職責(zé)和權(quán)限;
    e) 產(chǎn)品和服務(wù)的設(shè)計和開發(fā)所需的內(nèi)部和外部資源;
    f) 控制設(shè)計和開發(fā)過程涉及的個人之間的接口的需求;
    g) 顧客和用戶參與設(shè)計和開發(fā)過程的需求;
    h) 后續(xù)的產(chǎn)品和服務(wù)提供的要求;
    i) 顧客和其他有關(guān)相關(guān)方對設(shè)計和開發(fā)過程所期望的控制程度;
    j) 證實設(shè)計和開發(fā)要求已得到滿足所需的形成文件的信息。
    8.3.3 Design and development Inputs 設(shè)計和開發(fā)輸入
    The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider:
    a) functional and performance requirements;
    b) information derived from previous similar design and development activities;
    c) statutory and regulatory requirements;
    d) standards or codes of practice that the organization has committed to implement;
    e) potential consequences of failure due to the nature of the products and services.
    Inputs shall be adequate for design and development purposes, complete and unambiguous.
    Conflicting design and development inputs shall be resolved.
    The organization shall retain documented information on design and development inputs.
    組織應(yīng)確定有關(guān)設(shè)計和開發(fā)的產(chǎn)品和服務(wù)的具體類型的基本要求,組織應(yīng)考慮:
    a) 功能和性能要求;
    b) 來自以前類似設(shè)計和開發(fā)活動的信息;
    c) 法律法規(guī)要求;
    d) 組織承諾執(zhí)行的標(biāo)準(zhǔn)或行業(yè)規(guī)則;
    e) 產(chǎn)品和服務(wù)的性質(zhì)引起的潛在失效后果。
    輸入應(yīng)滿足設(shè)計和開發(fā)目的,完整并且清楚。
    設(shè)計和開發(fā)輸入的矛盾應(yīng)予以解決。
    組織應(yīng)保留設(shè)計和開發(fā)輸入的形成文件的信息。
    8.3.4 Design and development controls 設(shè)計和開發(fā)控制
    The organization shall apply controls to the design and development process to ensure that:
    a) the results to be achieved are defined;
    b) reviews are con
    組織應(yīng)策劃、實施和控制滿足產(chǎn)品和服務(wù)提供要求所需的過程(見4.4),并實施第6章確定的措施:
    a) 確定產(chǎn)品和服務(wù)的要求;
    b) 建立以下準(zhǔn)則:
    1) 過程;
    2) 產(chǎn)品和服務(wù)接收。
    c) 確定為達(dá)到產(chǎn)品和服務(wù)符合要求所需的資源;
    d) 按照準(zhǔn)則實施過程控制;
    e) 確定,保持和保留必要的形成文件的信息:
    1) 確信過程已按照策劃予以實施;
    2) 證實產(chǎn)品和服務(wù)與其要求的符合性。
    策劃的輸出應(yīng)適合組織的運(yùn)行。
    組織應(yīng)控制有計劃的變更,評審非預(yù)期的變更的后果,必要時采取措施減輕任何不良影響。
    組織應(yīng)確保外包過程得到控制(見8.4)。
    8.2 Requirements for products and services產(chǎn)品和服務(wù)要求
    8.2.1 Customer communication 顧客溝通
    Communication with customers shall include:
    a) providing information relating to products and services;
    b) handling enquiries, contracts or orders, including changes;
    c) obtaining customer feedback relating to products and services, including customer complaints;
    d) handling or controlling customer property;
    e) establishing specific requirements for contingency actions, when relevant.
    與顧客溝通應(yīng)包括:
    a) 提供與產(chǎn)品和服務(wù)有關(guān)的信息;
    b) 處理問詢,合同或訂單的處理,包括更改;
    c) 獲取顧客關(guān)于產(chǎn)品和服務(wù)的反饋,包括顧客抱怨;
    d) 顧客財產(chǎn)的處理和控制;
    e) 相關(guān)時,確定應(yīng)急措施的特定要求。
    8.2.2 Determination the requirements for products and services產(chǎn)品和服務(wù)要求的確定
    When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:
    a) the requirements for the products and services are defined, including:
    1) any applicable statutory and regulatory requirements;
    2) those considered necessary by the organization;
    b) the organization can meet the claims for the products and services it offers.
    在確定提供給顧客的產(chǎn)品和服務(wù)的要求時,組織應(yīng)確保:
    a) 產(chǎn)品和服務(wù)要求得到確定,包括:
    1) 適用的法律法規(guī)要求;
    2) 組織認(rèn)為必要的要求。
    b) 組織能夠滿足其所提供產(chǎn)品和服務(wù)的申明要求。
    8.2.3 Review of the requirements for products and services產(chǎn)品和服務(wù)要求的評審
    8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply
    products and services to a customer, to include:
    a) requirements specified by the customer, including the requirements for delivery and postdelivery activities;
    b) requirements not stated by the customer, but necessary for the specified or intended use, when known;
    c) requirements specified by the organization;
    d) statutory and regulatory requirements applicable to the products and services;
    e) contract or order requirements differing from those previously expressed.
    The organization shall ensure that contract or order requirements differing from those previously defined are resolved.
    The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.
    NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues.
    8.2.3.1 組織應(yīng)確保其有能力滿足提供給顧客的產(chǎn)品和服務(wù)的要求,組織應(yīng)在向顧客承諾提供產(chǎn)品和服務(wù)之前實施評審,包括:
    a) 顧客規(guī)定的要求,包括交付和交付后活動的要求;
    b) 顧客雖然沒有明示,但規(guī)定用途或已知的預(yù)期用途所必需的要求;
    c) 組織規(guī)定的要求;
    d) 適用于產(chǎn)品和服務(wù)的法律法規(guī)要求;
    e) 與以前表述不一致的合同或訂單的要求。
    組織應(yīng)確保與以前規(guī)定不一致的合同或訂單要求已得到解決。
    顧客沒有提供其要求的文件化說明時,組織應(yīng)在接受前對顧客要求進(jìn)行確認(rèn)。
    注:在某些情
    a) what will be done;
    b) what resources will be required;
    c) who will be responsible;
    d) when it will be completed;
    e) how the results will be evaluated.
    6.2.2 策劃如何實現(xiàn)其質(zhì)量目標(biāo)時,組織應(yīng)確定:
    a) 要做什么;
    b) 需要什么資源;
    c) 由誰負(fù)責(zé);
    d) 什么時候完成;
    e) 如何評價結(jié)果。
    6.3 Planning of changes 變更的策劃
    When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4).
    The organization shall consider:
    a) the purpose of the changes and their potential consequences;
    b) the integrity of the quality management system;
    c) the availability of resources;
    d) the allocation or reallocation of responsibilities and authorities.
    當(dāng)組織確定了質(zhì)量管理體系變更的需求時(見4.4),應(yīng)按策劃的方式進(jìn)行變更。
    組織應(yīng)考慮:
    a) 變更的目的及其潛在后果;
    b) 質(zhì)量管理體系的完整性;
    c) 資源的獲得;
    d) 職責(zé)和權(quán)限的分配與再分配。
    7 Support 支持
    7.1 Resources資源
    7.1.1 General 總則
    The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.
    The organization shall consider:
    a) the capabilities of, and constraints on, existing internal resources;
    b) what needs to be obtained from external providers.
    組織應(yīng)確定和提供建立、實施、保持和持續(xù)改進(jìn)質(zhì)量管理體系所需的資源。
    組織應(yīng)考慮:
    a) 現(xiàn)有內(nèi)部資源的能力和局限;
    b) 需要從外部供方獲取的資源。
    7.1.2 People 人
    The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.
    組織應(yīng)確定和提供質(zhì)量管理體系有效實施及過程的運(yùn)行和控制所需的人員。
    7.1.3 Infrastructure基礎(chǔ)設(shè)施
    The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
    NOTE Infrastructure can include:
    a) buildings and associated utilities;
    b) equipment, including hardware and software;
    c) transportation resources;
    d) information and communication technology.
    組織應(yīng)確定、提供并維護(hù)為達(dá)到產(chǎn)品和服務(wù)符合要求的過程的運(yùn)行所需的基礎(chǔ)設(shè)施。
    注:基礎(chǔ)設(shè)施可包括:
    a) 建筑物和相關(guān)的設(shè)施;
    b) 設(shè)備,包括硬件和軟件;
    c) 運(yùn)輸資源;
    d) 信息和通訊技術(shù)。
    7.1.4 Environment for the operation of processes 過程運(yùn)行環(huán)境
    The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
    NOTE A suitable environment can be a combination of human and physical factors, such as:
    a) social (e.g. non-discriminatory, calm, non-confrontational);
    b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
    c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).
    These factors can differ substantially depending on the products and services provided.
    組織應(yīng)確定、提供并維護(hù)過程的運(yùn)行和達(dá)到產(chǎn)品和服務(wù)的符合性所需的環(huán)境。
    注:適宜的環(huán)境可以是人文的因素和物理的因素的組合,例如:
    a) 社會的(如不歧視、平和、不對抗);
    b) 心理的(如降低壓力、倦怠預(yù)防、情感保護(hù))
    c) 物理的(溫度、熱度、濕度、照明、空氣流通、衛(wèi)生、噪音)
    根據(jù)所提供的產(chǎn)品和服務(wù),這些因素可能有顯著的差異。
    7.1.5 Monitoring and measuring resources 監(jiān)視和測量資源
    7.1.5.1 General
    The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.
    The organization shall ensure that the resources provided:
    a) are suitable for the specific type of monitoring and measurement activities being undertaken;
    b) are maintained to ensure their continuing fitness for their purpose.
    The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.
    7.1.5.1 總則
    當(dāng)監(jiān)視或測量用于產(chǎn)品和服務(wù)符合特定要求的證據(jù)時,組織應(yīng)確定和提供所需的資源以確保有效和可靠的結(jié)果。
    組織應(yīng)確保所提供的資源:
    a) 與所進(jìn)行的監(jiān)視和測量活動的具體類型相適應(yīng);
    b) 得到保持以確保其持續(xù)滿足使用要求。
    組織應(yīng)保留適當(dāng)?shù)男纬晌募男畔?,作為監(jiān)視和測量資源滿足使用要求的證據(jù)。
    7.1.5.2 Measurement traceability
    When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:
    a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;
    b) identified in order to determine their status;
    c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status
    and subsequent measurement results.
    The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.
    7.1.5.2 測量的追溯性
    8.4.3 Information for external providers 外部供方信息
    The organization shall ensure the adequacy of requirements prior to their communication to the external provider.
    The organization shall communicate to external providers its requirements for:
    a) the processes, products and services to be provided;
    b) the approval of:
    1) products and services;
    2) methods, processes and equipment
    3) the release of products and services;
    c) competence, including any required qualification of persons;
    d) the external providers’ interactions with the organization;
    e) control and monitoring of the external providers’ performance to be applied by the organization;
    f) verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises.
    在與外部供方溝通前,組織應(yīng)確保要求的充分性。
    組織應(yīng)與外部供方溝通其以下方面的要求:
    a) 將要提供的過程、產(chǎn)品和服務(wù);
    b) 以下批準(zhǔn):
    1) 產(chǎn)品和服務(wù);
    2) 方法、過程和設(shè)備;
    3) 產(chǎn)品和服務(wù)的放行;
    c) 能力,包含所要求的人員資格;
    d) 外部供方和組織之間的相互作用;
    e) 組織實施的對外部供方績效的控制和監(jiān)視;
    f) 組織或其顧客擬在外部供方現(xiàn)場實施的驗證或確認(rèn)活動。
    8.5 Production and service provision 生產(chǎn)和服務(wù)提供
    8.5.1 Control of production and service provision 生產(chǎn)和服務(wù)提供的控制
    The organization shall implement production and service provision under controlled conditions.
    Controlled conditions shall include, as applicable:
    a) the availability of documented information that defines:
    1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed;
    2) the results to be achieved;
    b) the availability and use of suitable monitoring and measuring resources;
    c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
    d) the use of suitable infrastructure and environment for the operation of processes;
    e) the appointment of competent persons, including any required qualification;
    f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
    g) the implementation of actions to prevent human error;
    h) the implementation of release, delivery and post-delivery activities..
    組織應(yīng)在受控條件下實施產(chǎn)品和服務(wù)的提供。
    適用時,受控條件應(yīng)包括:
    a) 獲得規(guī)定的形成文件的信息:
    1) 生產(chǎn)的產(chǎn)品、提供的服務(wù)或執(zhí)行的活動的特性
    2) 要達(dá)到的結(jié)果;
    b) 獲得和使用適宜的監(jiān)視和測量資源;
    c) 在適當(dāng)階段進(jìn)行監(jiān)視和測量,以驗證過程或輸出的控制準(zhǔn)則及產(chǎn)品和服務(wù)的接收準(zhǔn)則已得到滿足;
    d) 使用適宜的設(shè)備和過程環(huán)境;
    e) 指派勝任的人員,包括所要求的資格;
    f) 當(dāng)生產(chǎn)和服務(wù)提供過程形成的輸出不能由后續(xù)的監(jiān)視或測量加以驗證,組織應(yīng)對這些過程實現(xiàn)所策劃的結(jié)果的能力進(jìn)行確認(rèn)和定期再確認(rèn);
    g) 實施防止人為錯誤的措施;
    h) 實施產(chǎn)品和服務(wù)的放行、交付和交付后活動。
    8.5.2 Identification and traceability 標(biāo)識和可追溯性
    The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
    The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
    The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.
    必要時,組織應(yīng)使用適宜的方法識別輸出,以確保產(chǎn)品和服務(wù)的符合性。
    組織應(yīng)在產(chǎn)品和服務(wù)提供的全過程中,針對監(jiān)視和測量要求識別輸出的狀態(tài)。
    有可追溯性要求的場合,組織應(yīng)控制輸出的唯一性標(biāo)識,并應(yīng)保留可追溯性所需的形成文件的信息。
    8.5.3 Property belonging to customers or external providers 顧客或者外部供方財產(chǎn)
    The organization shall exercise care with property belonging to customers 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 customers’ or external providers’ property provided for use or incorporation into the products and services.
    When the
    — the size of organization and its type of activities, processes, products and services;
    — the complexity of processes and their interactions;
    — the competence of persons.
    組織的質(zhì)量管理體系應(yīng)包括:
    a) 本標(biāo)準(zhǔn)要求的形成文件的信息;
    b) 組織確定的為確保質(zhì)量管理體系有效運(yùn)行所需的形成文件的信息。
    注:不同組織的質(zhì)量管理體系形成文件的信息的程度可以因以下方面而不同:
    --組織的規(guī)模、活動、過程、產(chǎn)品和服務(wù)的類型;
    --過程及其相互作用的復(fù)雜程度;
    -- 人員的能力。
    7.5.2 Creating and updating 編制和更新
    When creating and updating documented information, the organization shall ensure appropriate:
    a) identification and description (e.g. a title, date, author, or reference number);
    b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
    c) review and approval for suitability and adequacy.
    在編制和更新形成文件的信息時,組織應(yīng)確保適當(dāng)?shù)模?
    a) 標(biāo)識和說明(例如:標(biāo)題、日期、作者、文件編號等);
    b) 格式(例如:語言、軟件版本、圖示)和媒介(例如:紙質(zhì)、電子);
    c) 評審和批準(zhǔn)以確保適宜性和充分性。
    7.5.3 Control of documented Information 形成文件的信息的控制
    7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
    a) it is available and suitable for use, where and when it is needed;
    b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
    7.5.3.1 應(yīng)對質(zhì)量管理體系和本標(biāo)準(zhǔn)所要求的形成文件的信息進(jìn)行控制,以確保:
    a) 在需要使用文件之處和之時能獲得適用的文件;
    b) 文件得到充分地保護(hù)(如防止泄密、使用不當(dāng)、缺損)。
    7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:
    a) distribution, access, retrieval and use;
    b) storage and preservation, including preservation of legibility;
    c) control of changes (e.g. version control);
    d) retention and disposition.
    Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.
    Documented information retained as evidence of conformity shall be protected from unintended alterations.
    NOTE Access can imply a decision regarding the permission to view the documented information only, or the
    permission and authority to view and change the documented information.
    7.5.3.2 適用時,組織應(yīng)實施以下活動對形成文件的信息進(jìn)行控制:
    a) 分發(fā)、獲取、檢索和使用;
    b) 儲存、保護(hù),包括保存易讀性;
    c) 更改的控制(如:版本控制);
    d) 保留和處置。
    組織所確定的策劃和運(yùn)行質(zhì)量管理體系所需的外來文件應(yīng)得到適當(dāng)?shù)淖R別和控制。
    作為符合性證據(jù)保留的形成文件的信息應(yīng)妥善保存以防止其非預(yù)期的失效。
    注:獲取是指有關(guān)形成文件的信息訪問許可的決定,或訪問和更改形成文件的信息的許可和權(quán)力。
    8 Operation 運(yùn)行
    8.1 Operational planning and control 運(yùn)行的策劃和控制
    The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:
    a) determining the requirements for the products and services;
    b) establishing criteria for:
    1) the processes;
    2) the acceptance of products and services;
    c) determining the resources needed to achieve conformity to the product and service requirements;
    d) implementing control of the processes in accordance with the criteria;
    e) determining, maintaining and retaining documented information to the extent necessary:
    1) to have confidence that the processes have been carried out as planned;
    2) to demonstrate the conformity of products and services to their requirements.
    The output of this planning shall be suitable for the organization’s operations.
    The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
    The organization shall ensure that outsourced processes are controlled (see 8.4).
    組織應(yīng)策劃、
    舟山寧波ISO90019公司ISO三體系價格
    8.5.3 Property belonging to customers or external providers 顧客或者外部供方財產(chǎn)
    The organization shall exercise care with property belonging to customers 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 customers’ or external providers’ property provided for use or incorporation into the products and services.
    When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.
    NOTE A customer’s or external provider’s property can include material, components, tools and equipment,
    premises, intellectual property and personal data.
    組織應(yīng)愛護(hù)在組織控制下或組織使用的顧客或外部供方財產(chǎn)。
    組織應(yīng)識別、驗證、保護(hù)和維護(hù)供其使用或構(gòu)成產(chǎn)品和服務(wù)的顧客或外部供方財產(chǎn)。
    若顧客或外部供方財產(chǎn)丟失、損壞或發(fā)現(xiàn)其他不適合使用的情況時,組織應(yīng)報告顧客或外部供方,并保留有關(guān)已發(fā)生狀況的形成文件的信息。
    注:顧客或外部供方財產(chǎn)可以包括材料、組件、工具和設(shè)備、顧客現(xiàn)場、知識產(chǎn)權(quán)和個人數(shù)據(jù)。
    8.5.4 Preservation 防護(hù)
    The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.
    NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection
    組織應(yīng)在產(chǎn)品和服務(wù)提供期間對輸出進(jìn)行必要的防護(hù),以確保符合要求。
    注:防護(hù)可以包括標(biāo)識、搬運(yùn)、污染控制、包裝、儲存、傳送或運(yùn)輸以及保護(hù)。
    8.5.5 Post-delivery activities 交付后活動
    The organization shall meet requirements for post-delivery activities associated with the products and services.
    In determining the extent of post-delivery activities that are required, the organization shall consider:
    a) statutory and regulatory requirements;
    b) the potential undesired consequences associated with its products and services;
    c) the nature, use and intended lifetime of its products and services;
    d) customer requirements;
    e) customer feedback.
    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..
    組織應(yīng)滿足與產(chǎn)品和服務(wù)有關(guān)的交付后活動的要求。
    在確定所需的交付后活動的程度時,組織應(yīng)考慮:
    a) 法律法規(guī)要求;
    b) 與產(chǎn)品和服務(wù)有關(guān)的潛在不期望的后果;
    c) 產(chǎn)品和服務(wù)的性質(zhì)、用途和預(yù)期壽命;
    d) 顧客要求;
    e) 顧客反饋。
    注:交付后活動可包括諸如擔(dān)保條件下的措施、合同規(guī)定的維護(hù)服務(wù)、附加服務(wù)如回收或最終處置。
    8.5.6 Control of changes 變更的控制
    The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.
    The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review..
    組織應(yīng)對生產(chǎn)或服務(wù)提供的變更進(jìn)行評審和控制,以確保必要的與持續(xù)符合要求。
    組織應(yīng)保留描述變更的評審結(jié)果、有權(quán)變更的人員以及評審引起的任何必要措施的形成文件的信息。
    8.6 Release of products and services 產(chǎn)品和服務(wù)放行
    The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.
    The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable by the customer.
    The organization shall retain documented information on the release of products and services. The documented information shall include:
    a) evidence of conformity with the acceptance criteria;
    b) traceability to the person(s) authorizing the release.
    組織應(yīng)在適當(dāng)階段實施策劃的安排,以驗證產(chǎn)品和服務(wù)要求已得到滿足。
    除非得到有關(guān)授權(quán)人員的批準(zhǔn),適用時得到顧客的批準(zhǔn),否則在策劃的安排已圓滿完成之前,不應(yīng)向顧客放行產(chǎn)品和服務(wù)。
    組織應(yīng)保留產(chǎn)品和服務(wù)放行的形成文件的信息,形成文件的信息應(yīng)包括:
    a) 符合接受準(zhǔn)則的證據(jù);
    b) 有權(quán)放行人員的可追溯性。
    8.7 Control of nonconforming process outputs不合格輸出的控制
    8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.
    The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.
    The organization shall deal with nonconforming outputs in one or more of the following ways:
    a) correction;
    b) segregation, containment, return or suspension of provision of products and services;
    c) informing the custom
    -/gbaabgg/-

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