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    武冈AS9120_AS9120B质量管理体系 航空 航天和防务分销商的要求8.4.3提供给外部供方的信息-纵横世纪-2023年
    发表时间:2021-01-22     阅读次数:     字体:【

    8.4.3、提供给外部供方的信息

    组织应确保在与外部供方沟通之前所确定的要求是充分和适宜的。

    组织应与外部供方沟通以下要求:

    a)所提供的过程、产品和服务,包括相关技术数据的标识(如规范,图纸,过程要求,和工作指导书);

    b)对下列内容的批准:

    1)产品和服务;

    2)方法、过程和设备;

    3)产品和服务的放行;

    c)能力,包括所要求的人员资质;

    d)外部供方与组织的接口;

    e)组织对外部供方绩效的控制和监视;

    f)组织或其顾客拟在外部供方现场实施的验证或确认活动;

    g)设计和开发控制;

    h)特殊要求,关键项目,包括关键特性 ;

    g)试验,检验和验证(包括生产过程的验证)

    h)使用组织能接受的统计技术来进行产品验收和相关说明;

    i)需要

    —— 执行的质量管理体系;

    —— 使用顾客指定或批准的外部供方,包括过程来源(如特殊过程);

    —— 向组织通报不合格的过程,产品或服务并获得处置批准;

    —— 预防使用未经批准的、疑似未经批准的、仿冒的零件(见 8.1.4和 8.1.5);

    —— 通知组织关于过程/产品或服务的更改,包括他们的外部供方的更改、生产地点的更改,并获得组织的批准

    —— 向外部供方传递适用的要求,包括顾客要求;

    —— 适用时,提供符合性证明(COC)、测试报告及授权放行证;提供试验件用于设计批准、检验/验证、调查或审核(例如生产方法,编号,储存条件);

    —— 需要保留的文件信息,包括保留期和处置要求。

    j)在供应链的任何层次,组织及其顾客和监管机关可接触进入到任何适用的场所,和适用文件信息的权利。

    k)保证人员意识到

    —— 他们对产品和服务符合性的贡献;

    —— 他们对产品安全的贡献;

    —— 符合道德标准的行为的重要性。

    8.4.3、Information for External Providers

    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 including the identification of relevant technical data (e.g., specifications, drawings, process requirements, work instructions);

    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;

    g. test, inspection, and verification;

    h. the use of statistical techniques for product acceptance and related instructions for acceptance by the organization;

    i. the need to:

    —— implement a quality management system;

    —— use customer-designated or approved external providers, including process sources (e.g., special processes);

    —— notify the organization of nonconforming processes, products, or services and obtain approval for their disposition;

    —— prevent the use of suspected unapproved, unapproved, and counterfeit parts (see 8.1.4 and 8.1.5);

    —— notify the organization of changes to processes, products, or services, including changes of their external providers or location of manufacture;

    —— flow down to external providers applicable requirements including customer requirements;

    —— provide a certificate of conformity, test reports, or authorized release certificate, as applicable;

    —— retain documented information, including retention periods and disposition requirements;

    j. the right of access by the organization, their customer, and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the supply chain;

    k. ensuring that persons are aware of:

    —— their contribution to product or service conformity;

    —— their contribution to product safety;

    —— the importance of ethical behavior.


     
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