ISO9001-8.4 .2

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8.4.2 控制类型和程度

组织应确保外部供方提供的过程、产品和服务不会对组织稳定地向顾客交付合格产品和服务的能力产生不利影响。

组织应：

a) 确保外部提供的过程保持在其质量管理体系的控制之中；

b) 规定对外部供方的控制及其输出结果的控制；

c) 考虑：

1）外部提供的过程、产品和服务对组织稳定地满足顾客要求和适用的法律法规要求的能力的潜在影响；

2）由外部供方实施控制的有效性；

d）确定必要的验证或其他活动，以确保外部提供的过程、产品和服务满足要求

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8.4.2 Control type and degree



The organization should ensure that the processes, products, and services provided by external suppliers do not have an adverse impact on the organization's ability to stably deliver qualified products and services to customers.



Organizations should:



a) Ensure that externally provided processes are maintained within the control of their quality management system;



b) Regulate the control of external suppliers and the control of their output results;



c) Consider:



1) The potential impact of externally provided processes, products, and services on the organization's ability to stably meet customer requirements and applicable legal and regulatory requirements;



2) Effectiveness of control implemented by external suppliers;



d) Determine necessary validation or other activities to ensure that externally provided processes, products, and services meet requirements

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外部供方所提供产品或服务对组织最终提供给顾客产品或服务的决定或影响程度，例如对于核心关键原材料，即使供应商业绩很好，也不能掉以轻心，严格、繁琐的每批次进货检验、使用过程质量确认等必须不间断进行，因为一旦放松导致不合格产品的使用，将直接使组织的最终产品出现难以修复（返工、返修等）的不合格或缺陷，以及由此导致的向其客户的巨额赔偿乃至仅一次不合格就导致从客户供应商名录上除名。

——组织自身的质量意识与要求，当外部供方提供的产品或服务质量至关重要且组织质量意识与要求非常高时，会出现由组织直接指定外部供方的外部供方，以及派人常驻外部供方现场进行监督的情形，或者委托权威的第三方在外部供方现场进行过程检测、产品检验或服务验收。

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The degree to which the products or services provided by external suppliers have an impact on the organization's final decision to provide products or services to customers. For example, for core critical raw materials, even if the supplier's performance is good, they cannot be taken lightly. Strict and cumbersome inspections of each batch of incoming goods, quality confirmation of the use process, etc. must be carried out continuously, because once relaxation leads to the use of unqualified products, It will directly cause the organization's final products to have non conformities or defects that are difficult to repair (rework, repair, etc.), as well as resulting in huge compensation to its customers and even one non conformity, leading to delisting from the customer supplier list.




——When the quality awareness and requirements of the organization's own products or services provided by external suppliers are crucial and the organization's quality awareness and requirements are very high, there may be situations where the organization directly designates external suppliers, sends personnel to the external supplier's site for supervision, or entrusts authoritative third parties to conduct process testing, product inspection, or service acceptance at the external supplier's site.