ISO9001-8.4

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8.4.1 总则

组织应确保外部提供的过程、产品和服务符合要求。

在下列情况下，组织应确定对外部提供的过程、产品和服务实施的控制：

a）外部供方的产品和服务将构成组织自身产品和服务的一部分；

b）外部供方代表组织直接将产品和服务提供给顾客；

c）组织决定由外部供方提供过程或部分过程。

组织应基于外部供方按照要求提供过程、产品和服务的能力，确定并实施对外部供方的评价、选择、绩效监视以及再评价的准则。对于这些活动和由评价引发的任何必要的措施，组织应保留成文信息。

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8.4.1 General



Organizations should ensure that externally provided processes, products, and services meet requirements.



In the following situations, the organization should determine the control over the implementation of externally provided processes, products, and services:



a) The products and services of external suppliers will form a part of the organization's own products and services;



b) External suppliers represent organizations that directly provide products and services to customers;



c) The organization decides to have external suppliers provide the process or part of the process.



Organizations should determine and implement criteria for the evaluation, selection, performance monitoring, and re evaluation of external suppliers based on their ability to provide processes, products, and services as required. For these activities and any necessary measures triggered by evaluations, the organization should retain documented information.

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组织应分别制定对这些外部供方所提供产品或服务质量的能力进行评估、对其选择以及业绩评价的准则（即标准与流程，最好以程序文件来体现），业绩评价结果可能导致外部供方名录的变更，个别外部供方可能会被淘汰或强制要求整改达到预定要求，否则会被淘汰。

相应程序文件可有《供应商评估、选定与业绩评价管理程序》、《承包商评估、选定与业绩评价管理程序》、《服务商评估、选定与业绩评价管理程序

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Organizations should develop criteria for evaluating the quality of products or services provided by these external suppliers, selecting them, and evaluating their performance (i.e. standards and processes, preferably reflected in procedural documents). Performance evaluation results may lead to changes in the list of external suppliers, and individual external suppliers may be eliminated or forced to rectify to meet predetermined requirements, otherwise they may be eliminated.
The corresponding program files can include "Supplier Evaluation, Selection, and Performance Evaluation Management Procedure", "Contractor Evaluation, Selection, and Performance Evaluation Management Procedure", and "Service Provider Evaluation, Selection, and Performance Evaluation Management Procedure"