The organizationshall identify, verify, protect, and safeguard customer property provided foruse or incorporation into the product while it is under the organization’scontrol or being used by the organization. If any customer property is lost,damaged or otherwise found to be unsuitable for use, the organization shallreport this to the customer and maintain records (see 4.2.5).
當產品在組織的控制下或準備在組織中使用時,組織應當確定、核實、保護和保衛供其使用或構成產品一部分的顧客財產。如果任何顧客財產損失、毀壞或發現不適用情況時,組織應當向客戶進行告知并保留相關記錄(見4.2.5)。
刪減YY/T0287備注項。
7.5.11 Preservation of product 產品防護
The organization shalldocument procedures for preserving the conformity of product to requirements duringprocessing, storage, handling, and distribution. Preservation shall apply tothe constituent parts of a medical device.
組織應當建立防護程序用以在制造、存儲、處理和銷售過程中防護產品從而符合產品防護方面的要求,防護也應適用于產品的組成部分。
The organization shall protectproduct from alteration, contamination or damage when exposed to expectedconditions and hazards during processing, storage, handling, and distributionby:
當產品處于在預期的條件下以及處于生產過程、存儲、處理和銷售的危害下時,組織應當通過以此措施保護產品遠離變化、污染、損害:
a) designing and constructingsuitable packaging and shipping containers;
設計和制造合適包裝和運輸容器;
b) documenting requirements forspecial conditions needed if packaging alone cannot provide preservation.
如果僅靠包裝不能提供保護時,針對專有的必須的條件形成文件化的要求。
If special conditions are required,they shall be controlled and recorded (see 4.2.5).
如果確實需要特殊情況,這些情況應當予以控制和記錄(見4.2.5)
本部分內容描述與YY/T0287有很多不同。
總結:本部分內容與YY/T0287最大的不同是文件格式排序不一樣。其次三個部分文件內容增加最多,變化最大。7.5.4、7.5.7和7.5.11。