Quality management system
質量管理體系
4.1 General requirements 一般要求
4.1.4 The organizationshall manage these quality management system processes in accordance with therequirements of this International Standard and applicable regulatoryrequirements. Changes to be made to these processes shall be:
組織應當依據本國際標準和適當的法規要求管理這些質量管理體系過程。這些過程的改變（變更）應當：（新增）
a) evaluated fortheir impact on the quality management system;
評價其對于質量管理體系的影響；（新增）
b) evaluated for their impact on themedical devices produced under this quality management system;
評價其對于在此質量管理體系下生產的醫療器械的影響；（新增）
c) controlled inaccordance with the requirements of this International Standard and applicable regulatoryrequirements.
依據本國際標準和適當的法規要求進行控制。（新增）
4.1.5 When theorganization chooses to outsource any process that affects product conformityto requirements, it shall monitor and ensure control over such processes. The organizationshall retain responsibility of conformity to this International Standard and tocustomer and applicable regulatory requirements for outsourced processes. Thecontrols shall be proportionate to the risk involved and the ability of theexternal party to meet the requirements in accordance with 7.4. The controlsshall include written quality agreements.
當組織選擇外包（委托）任何影響產品符合要求的過程時，這些過程都應當被監控并確保這些過程控制。對于外包（委托）過程。組織應當具有符合國際標準、符合客戶、符合適當法規要求的職責?？刂茟斉c所涉的風險以及外部組織的能力相適應，并且符合7.4項下的要求?？刂茟敯〞娴馁|量協議。（新增，委托）
4.1.6 The organizationshall document procedures for the validation of the application of computer softwareused in the quality management system. Such software applications shall bevalidated prior to initial use and, as appropriate, after changes to suchsoftware or its application.
組織應當建議文件化的程序用于應用于質量管理體系計算機軟件應用程序的驗證。這類軟件應用程序的驗證應當在初始使用前進行驗證，并在對該軟件或其應用程序更改后進行驗證。（新增，計算機系統驗證）
The specificapproach and activities associated with software validation and revalidationshall be proportionate to the risk associated with the use of the software.
Records of such activities shall bemaintained (see 4.2.5).
與軟件驗證和再驗證相關的專門方法和措施應當使用該軟件的風險相適應。這類措施的記錄應當被保留》（見4.2.5）（新增）
注意：涂色字體加粗部分為新增部分，其余部分與YY/T0287-2003基本一致。