8.5.8.2 生產和服務提供的確認d 確保保留了形成文件的資訊，保留

8.5.8.2 Confirmation of production and service provision d Ensure that the documented information is retained and the form of retention (electronic, hard copy, file), so that the organization can meet the response time requirements; <br>e Ensure the serialization of individual products, such as customers Or regulatory standards have provisions; <br>f to ensure that the identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics <br>8.5.10.4 Refer to [Product Identification and Traceability Management Procedures] for implementation details. <br>8.5.11 Property of customers or external suppliers <br>8.5.11.1 The information provided by customers or external suppliers shall be managed in accordance with [Document Control Management Procedure]. However, if all units have short-term possession of articles or equipment provided by customers or external suppliers for special reasons, they should be controlled in accordance with the following principles

8.5.8.2 The d guarantee provided by the production and service retains the form of the file, the form of the reservation (tyrone, torture, case), so that the 織 can meet the time requirements; <br>e Ensure that the serialization of each product, such as 顧 or 監, is determined; <br>f The protection and traceability requirements are 擴 to externally supplied products with 監/or tube characteristics.<br>8.5.10.4 Follow the Product Traceability Management Procedure.<br>8.5.11 顧 a customer or external 財 provider.<br>8.5.11.1 For 顧 or external providers, the information provided is managed in accordance with the Document Control Management Procedure. However, for special reasons, the short-term possession of items or 儀 devices supplied by 顧 customers or external providers shall be controlled in accordance with the following original conditions.

8.5.8.2 confirmation of production and service provision D ensure that documented information is retained in the form (electronic, hard copy, file) to enable the organization to meet the response time requirements;<br>E. ensure the serial identification of individual products, if specified by customers or regulatory standards;<br>F ensure that the identification and traceability requirements are extended to externally supplied products with safety / regulatory characteristics<br>8.5.10.4 refer to the management procedure for product identification and traceability for detailed implementation rules.<br>8.5.11 customer or external supplier property<br>[11.1.5] or the external management procedures of suppliers. However, if, for special reasons, units hold items or equipment provided by customers or external suppliers for a short time, they should control them in accordance with the following principles<br>