Quality management system
质量管理体系
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:
组织应当依据本国际标准和适当的法规要求管理这些质量管理体系过程。这些过程的改变（变更）应当：（新增）
a) evaluated fortheir impact on the quality management system;
评价其对于质量管理体系的影响；（新增）
b) evaluated for their impact on themedical devices produced under this quality management system;
评价其对于在此质量管理体系下生产的医疗器械的影响；（新增）
c) controlled inaccordance with the requirements of this International Standard and applicable regulatoryrequirements.
依据本国际标准和适当的法规要求进行控制。（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.
当组织选择外包（委托）任何影响产品符合要求的过程时，这些过程都应当被监控并确保这些过程控制。对于外包（委托）过程。组织应当具有符合国际标准、符合客户、符合适当法规要求的职责。控制应当与所涉的风险以及外部组织的能力相适应，并且符合7.4项下的要求。控制应当包括书面的质量协议。（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.
组织应当建议文件化的程序用于应用于质量管理体系计算机软件应用程序的验证。这类软件应用程序的验证应当在初始使用前进行验证，并在对该软件或其应用程序更改后进行验证。（新增，计算机系统验证）
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).
与软件验证和再验证相关的专门方法和措施应当使用该软件的风险相适应。这类措施的记录应当被保留》（见4.2.5）（新增）
注意：涂色字体加粗部分为新增部分，其余部分与YY/T0287-2003基本一致。