ISO13485 Renew Audit By UL

上周（12月18日--12月22日），UL来我公司进行ISO13485(医疗产品体系)换证审核。一直都没有时间来6 SQ,总算比较顺利通过换证审核,但还有4个轻微不符合项.当然,我也是身心疲惫的度过了这一周,因为公司没有专门的司机,我既要当司机,又要应对审核;每天都要早上7点开始忙碌到晚上10点.换证审核过程,我个人认为与年度监督审核有以下不同的地方:

1. 组织内部审核不能仅仅采用条款或部门进行审核.而是要明确采用过程方法(最好采用TS16949的乌龟图来进行).以确保各部门之间的交织部分被有效审核。
2. UL审核员把前3年的UL开给我们的不符合项一一再确认并关闭.
3. 此次换证审核时,若发现轻微不符合项与前3年的UL开出的轻微不符合项有重复,则评定为严重不符合项.
4. UL审核员把前3年的内审发现的不符合项一一比对,确认是否上年度的不符合项在下年度是否再发生.若有,算是严重不符合项.
5. 在进行审核过程中,UL审核员采用乌龟图与被审核人员确认:输入、设备/工具等、实施人、流程或方法、输出、绩效指标。
6. 审核员的CHECKING LIST有160多页，而且抽样频度很高，基本上5—6个样本.
7. 不仅仅是在新产品开发阶段与客户之间的沟通，或在客户满意调查时候进行的沟通，或是客户投诉进行的沟通。而且需要客户在不同事情对组织的评价和与客户之间的沟通或反馈。
8. 管理评审不能只简单定出下年度的目标或计划，而应该要有详细的评估：比如，为何要增加新的目标或修订目标？会对体系有作用或影响？对其他的目标是否有影响或负作用？等等

PP：我公司被开出的4个轻微不符合项如下：

1. The established process for document control was not satisfactorily implemented. There Was no objective evidence to show that one copy of obsolete controlled documents were retained at least the lifetime of the medical device as defined in Organization’s Document Control Procedure #-----------

1. The established process of corrective action is not implemented effectively as seen in 4 out of 6 Corrective Action reports of Internal Audits sampled and verified. The Organization did not determine and recorded the cause of the nonconformities, as per the documented CA and PA Control Procedure #-------Rev B.

1. The established process monitoring and measurement is not effective. Against the Mold middle temperature of 218±15℃, observed during audit was 200℃. Against Mold total pressure 80±30Kg/cm2,observed during audit was 120Kg/cm2, WI:------, Rev A, 2002/11/30.

1. The process of validation is not implemented effectively. The validation record of product------ can’t indicate which injection molding machine used and without waived judged record of IQ.