标题: E4 [打印本页] 作者: 简单晃 时间: 2011-10-24 17:54 标题: E4 今天E4 - MARK监审，CQC审核员给我们开的不符合项，不知道如何整改，希望高手能指点一下，谢谢！
1、The requirement(cop)not followed不遵守（COP）要求
Relevant directives and regulations should be available for the auditors.
有关指令和法规应该被用于审核员。
证据：1）The directive of 72/245/EEC,2006/28/EC,and ECE regulation R10.03 are not available and updated;未收集和更新指令72/245/EEC，2006/28/EC，欧洲经委会和监管R10.03。
2）"Control procedure for regulation collection and update"are laid down,but no requirements specified on how to collect the directive/regulation,the responsible person,the frequency and the update review were described.“控制程序收集和更新"规定了下来,但没有规定如何收集指令/监管,负责的人,频率和更新进行描述
2、The requirement(cop)not followed不遵守（COP）要求
COP tests and checks data should be performed,recorded and available for the auditor COP测试和检查应进行记录数据,并可以进行审核
证据：1）The outsourced COP tests and checks required by The EC directive and regulation R10 were not performed;不执行欧共体的指令和规定R10的要求COP的委外测试和检查;
2）No outsourced COP checks and test data were recorded and available for the auditor.没有委外COP检查和试验数据进行记录，并可以进行审核。