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13485体系文件换版

公司计划明年完成13485 换版认证工作,目前什么都没有准备,该如何着手
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shiny888 (威望:94) (上海 闵行区) 电子制造 VP of Quality

赞同来自: ll8899 simon_yan allen_617 djtsang helen_lyz0620

You should do gap analysis from Annex 1 which is detail comparasion from 2003 ver VS 2016 ver:
Clear clarified differential on each elements,pls becareful on 6.4 working enviroment and contaimination which add requirement on microorganism and particular control; 7.4 Purchasing control,a lot of new requirements added for exist supplier re-evaluation;8.3 control of non conforming,clear statements on concession release ,I believe your company have such kind of cases.
 
These are what I am focusing on....hopefully helps..
 

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