What is a controlled document ISO 9001? A controlled document is a document that is subject to control by the quality management system. The purpose of a controlled document is to ensure that the information it contains is accurate and up-to-date. Controlled documents must be approved by an authorized individual before they can be released. The release of a controlled document should be documented and controlled to prevent unauthorized release.

ISO 9001受控文件是一种质量管理体系（QMS）文件，其中包含为确保产品或服务质量而必须遵循的指令或程序。这些文件可能是公司内部的，也可能是由外部方提供的，如认证机构。

有不同类型的受控文件，可以根据其目的进行分类。例如，一些受控文件可能包含产品或服务应该如何设计或制造的规范，而其他文件可能提供如何进行测试或检查过程的说明。还有一些文件可能规定了产品或服务必须满足的要求，以使其被认为符合ISO 9001标准。

ISO 9001受控文件的具体内容将因其所涉及的具体质量管理体系而有所不同。然而，所有受控文件都应该是清晰和简洁的，并应定期审查和更新，以确保它们保持准确和有效。

Controlled documents are an important part of any quality management system, as they help to ensure that all activities related to the production or provision of a product or service are carried out in a consistent and reliable manner. When used properly, controlled documents can help to improve the overall quality of a company’s products or services, and can contribute to increased customer satisfaction levels.

If you are thinking about implementing a quality management system in your business, or if you are already using one but are looking to improve your documentation, then ISO 9001 can help. This international standard provides guidance on how to develop and implement an effective quality management system, and includes requirements for controlled documents. By following the requirements of ISO 9001, you can help to ensure that your company’s quality management system is effective and able to meet the needs of your customers.