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现场评审实验室“授权签字人”条款的应用

发表时间:2018-08-20 00:00来源:北京大陆航星质量认证中心

[摘  要]:《检 验检测机构资质认定评审准则》(2016版)已于2016年8月施行。如何正确理解和运用新评审准则的相关要求,是各类检验检测机构面临的一项新任务。文 章依据新评审准则要求,对评审过程中主要存在的问题进行了剖析,并提出相应的措施,为相关部门更好地贯彻实施该准则提供一些参考。

[关键词]:实验室 授权签字人 管控方法 审核要点

WEI BUDUANTISHENGJIANYANJIANCEFUWUYEFAZHANSHUIPING,TIGAOJIANYANJIANCEJIGOUJIANYANGONGZUODEGUIFANXING,2016NIAN6YUECHU,GUOJIARENJIANWEIFABULEXINBAN《JIANYANJIANCEJIGOUZIZHIRENDINGPINGSHENZHUNZE》 (2016BAN)(YIXIAJIANCHENG《PINGSHENZHUNZE》)BINGYUDANGNIAN8YUESHISHI。SHIYANSHIDUISHOUQUANQIANZIRENDEGUANZHUYUGUANKONGSHIGAIZHUNZEZHONGDEZHONGYAONEIRONG。JIANLIHEBAOCHISHIYANSHISHOUQUANQIANZIRENDEZHIZEYUQUAN XIAN,SHIBAOZHENGSHIYANSHIGONGZUOBUSHOURENHEBUZHENGDANGDEGANRAOHEYINGXIANG,BAOZHENGJIANYANJIANCEGONGZUODEGONGZHENGXING、DULIXINGHEYOUXIAOXING,DUITIGAOJIANYANJIANCEJIGOUSHIYANCHENGGUOZHILIANGJUYOUZHONGYAOYIYI。

经过一年多的《评审准则》贯彻执行,我们对部分获证实验室授权签字人管控情况、执业行为及能力展开调查研究,对其管理过程中的存在问题进行了分析探讨,目的在于准确理解准则和应用准则,进一步推动《评审准则》的贯彻和实施。

一、实验室检验报告存在的问题和原因分析

2016 NIAN11YUE,SHANDONGSHENGZHILIANGJISHUJIANDUJUZUZHILEJINBAIMINGZHUANJIA,FEN30GEJIANCHAZU,DUIQUANSHENG180JIAJIANYANJIANCEJIGOUKAIZHANLEFEIXINGJIANCHA,SHEJISHIPINANQUAN、JIKONG、HUANBAO、GUANCHEJIANYANDENGJIAN YANJIANCEJIGOU。ANZHAOSHIXIANBUSHUDE18GEJIANCHAXIANGMU,DUISHIYANSHIDEJIANYANJIANCEHUODONGHEFAXING、GUANLITIXIDECHENGXINKEKAOXING、JIANYANBAOGAODEGUIFANXINGDENGNEIRONGJINXINGZHUANXIANGJIANDUJIANCHA。CICIFEIXINGJIAN CHAFAXIANDEPUBIANXINGWENTIZHIYIJIUSHIJIANYANBAOGAOBUGUIFAN。ZHUYAOTIXIANZAIJIANYANBAOGAOSUOFUDAIDEYUANSHIJILUXINXIBUWANZHENG,KESUYUANXINGCHA。BUFENJIANYANBAOGAOCUNZAIYUYUANSHIJILUWUWEIYIXINGBIANHAO、WUXIANG GUANJIANYANSHEBEIXINXI、HUAGAIJIANYANJILU、JIANCERENYUANBUQIANZIDENGWENTI。ZAISUOCHOUCHADEGUANCHEJIANYANJIGOUZHONG,XITONGXINGDICUNZAIJIANYANRENYUAN、SHENHERENYUAN、PIZHUNRENYUANJUNWEIZAIJIANYANBAOGAOSHANGQIANZIHUOZHEYONG DIANZIDAYINDAITISHOUQIANDEQINGKUANG。

TONG GUODUIBUFENHUOZHENGJIANYANJIANCEJIGOUSHOUQUANQIANZIRENGUANKONGQINGKUANG、ZHIYEXINGWEIHENENGLIDIAOCHAFENXI,FAXIANCHANSHENGSHANGSHUWENTIDEZHUYAOYUANYIN:YISHISHOUQUANQIANZIRENNENGLIMINGXIANBUZU;ERSHISHOUQUANQIANZIRENZHUANYEXING BUQIANG,WUXIANGGUANZHUANYEJIAOYUBEIJINGHEGONGZUOJINGLI;SANSHIJIANYANJIANCEJIGOUXINGZHENGLINGDAOJIANRENSHOUQUANQIANZIRENJIAODUO;SISHISHOUQUANQIANZIRENZERENXINJIAOCHA;WUSHINIANDUPEIXUNJIAOYUQIANQUE,ZHISHICHENJIU,DUIJIANYAN JIANCEXINZHISHI、XINJISHU、XINFANGFABUSHUXI;LIUSHIDUISHOUQUANQIANZIRENPINGJIAKAOHEJIZHIYOUDAIJIAQIANGWANSHAN。YOUCIRENWEI,BENDIQUDANGQIANHEJINHOUYIGESHIQI,JIAQIANGHEGAIJINGELEIJIANYANJIANCEJIGOUSHOUQUANQIAN ZIRENDEJIANGUAN,JUYOUSHIFENZHONGYAODEXIANSHIYIYI。

二、正确理解《评审准则》4.2.4条款的要求

JIAN YANJIANCESHIYANSHIJIANLIHEYUNXINGGUANKONGCHENGXUDEMUDESHIWEILEBAOZHENGJIANYANJIANCEJIGOUJIQISHOUQUANQIANZIRENBUSHOULAIZINEIWAIBUDE、BUZHENGDANGDESHANGYE、CAIWUHEQITAFANGMIANDEYALIHEYINGXIANG,DULIWANCHENGXIANGGUAN DEJISHUHUODONG,QUEBAOJIANYANJIANCESHUJU、JIEGUODEZHENSHI、KEGUAN、ZHUNQUEHEKEZHUISU,JIANYANJIANCEJIGOUXUYAOGUANZHUYUGUANKONGZISHENNEIBUGEZHUANYELEIBIESHOUQUANQIANZIRENDEZHIYEXINGWEIJINENGLI。SHIYANSHIYIJU 《PINGSHENZHUNZE》DI4.2.4TIAOKUANYAOQIU“JIANYANJIANCEJIGOUDESHOUQUANQIANZIRENYINGJUYOUZHONGJIJIYISHANGXIANGGUANZHUANYEJISHUZHICHENGHUOTONGDENGNENGLI,BINGJINGZIZHIRENDINGBUMENPIZHUN。FEISHOUQUANQIANZIRENBUDEQIANFA JIANYANJIANCEBAOGAOHUOZHENGSHU。”

“SHOUQUANQIANZIREN”BIXUDUIJIANCESHIYANSHIDECHANPIN(JIJIANCEBAOGAO)ZHILIANGFUQUANMIANDEZEREN,BINGCHENGDANFALVZEREN,TONGSHIHAIYAODUIPIZHUN“SHOUQUANQIANZIREN”DESHANGJIJIGOUFUZE。

SHOU QUANQIANZIRENSHIZHIYOUSHIYANSHITIMING,JINGZIZHIRENDINGBUMENKAOHEHEGEHOU,YOUBENJIGOUZAIQINENGLIFANWEINEISHOUQUANDEQIANFAJIANYANJIANCEBAOGAOHUOZHENGSHUDERENYUAN。ZHEILIDEBAOGAOHUOZHENGSHUZHIDAIYOUZIZHIRENDINGBIAOSHI DE。FEISHOUQUANQIANZIRENBUDEQIANFAJIANYANJIANCEBAOGAOHUOZHENGSHU。SHOUQUANQIANZIRENDUIJIANYANJIANCEJIEGUODEZHUNQUEXINGPANDUANYINGYOUZUGOUDEJISHUZIGEHEJINGYAN,TONGSHIHAIYAODUIJIANYANJIANCEJIEGUOCHENGDANJISHUHEFALVZE REN。YINCI,YAOQIUSHOUQUANQIANZIRENYINGJUYOUZHONGJIJIYISHANGXIANGGUANZHUANYEJISHUZHICHENGHUOTONGDENGNENGLI,JUBEIXIANGYINGDEJIAOYUBEIJINGHEGONGZUOJINGLI,JINGKAOHEHEGE,BINGJINGZIZHIRENDINGBUMENPIZHUN。

PINGSHENYUANYIJU4.2.4TIAOKUANSHISHISHENHESHI,RUHECHONGFENLIJIE《PINGSHENZHUNZE》DEYAOQIU,ZHUNQUEPANDINGSHIYANSHISHOUQUANQIANZIRENDEZIGEJINENGLI,YOUXIAOZHIDINGPINGSHENNEIRONGJIFANGFA,YIQUEBAOSHENHEDEYOUXIAOXING,SHIMUQIAN《PINGSHENZHUNZE》SHENHEZHONGJIDAIJIEJUEDEWENTIZHIYI。

三、《评审准则》4.2.4条款的实现过程研究

SHI YANSHIDEGUANLIFENWEIZHILIANGGUANLI、JISHUGUANLIHEXINGZHENGGUANLI。JISHUGUANLISHIJIANYANJIANCEJIGOUGONGZUODEZHUXIAN,ZHILIANGGUANLISHIJISHUGUANLIDEBAOZHANG,XINGZHENGGUANLISHIJISHUGUANLIZIYUANDEZHICHENG。SHIYANSHIJISHU GUANLIDEZHUYAONEIRONGZHIYIJIUSHIDUISHIYANSHISHOUQUANQIANZIRENJISHUGUANKONG。XIAMIANYISHANDONGSHENGSHUILIGONGCHENGSHIYANZHONGXIN(YIXIAJIANCHENG“SHIYANZHONGXIN”)SHIYANSHISHOUQUANQIANZIRENGUANKONGWEILI,TANTAOSHIYANSHISHOUQUANQIAN ZIRENZHIZEQUANXIAN、GUANKONGYAODIAN、KAOHENEIRONGJIQIPINGSHENSILUDENGWENTI。

1.SHIYONGFANWEI

SHIYONGYUSHIYANZHONGXINNEIBUGEZHUANYELEIBIESHOUQUANQIANZIREN。

2.YINGJUBEIDEZIZHIHENENGLI

①JUYOUSHOUQUANYEWUFANWEINEIDEZHUANYEZHISHI,BINGJUYOUCONGSHIJIANYANGONGZUO5NIANYISHANGJINGYAN。

②SHUXIZHUANYEBIAOZHUN、JISHUGUIFANHEXIANGGUANDEFALV、FAGUI,LEJIEJIANCEYIQISHEBEIDEXINGNENG,YOUJIEJUEJISHUWENTIDENENGLIHEYIDINGDEYEWUSHUIPING;SHUXIXIANGYINGDEJIANCEGUANLIDECHENGXUHEJILU、BAOGAOHECHADECHENGXU。

③SHUXIJIANCECHENGXUHEFANGFA,BINGNENGCHULIJIANCEGUOCHENGZHONGYUDAODEYIQIEWENTI;SHULIANZHANGWOYOUGUANJIANCEXIANGMUDESHOUXIANFANWEI。

④JUYOUBENKEXUELIHEGAOJIGONGCHENGSHIYISHANG(HANGAOJIGONGCHENGSHI)JISHUZHICHENGHUOTONGDENGNENGLI,SHUXIYEWU,JINGKAOHEHEGE。

⑤FUZESHENCHAFENXIJIEGUOBAOGAODEWANZHENGXING、XIANGMUDEQIQUANXINGHEJIELUNDEZHENGQUEXING;JUYOUFENXIJIANYANJIEGUOJINXINGDULIPANDINGDENENGLI。

3.SHOUQUAN

SHIYANZHONGXINDUISHOUQUANQIANZIRENDESHOUQUANSUOSHEJIDEZHUYAONEIRONG:

①JINGZHIJIANJUKAOHEHEGE,BINGCHIGUOJIA、SHENG、SHIHUOSHANGJIZHUGUANBUMENBANFADE《JIANCESHIYANRENYUANZIGEZHENGSHU》DESHOUQUANQIANZIREN,SHOUQUANQIANZIFANWEIWEIZHILIANGJISHUJIANDUJUPIZHUNDEFANWEI。

②SHOUQUANQIANZIRENQIANFASHIYANZHONGXINJIANCEFANWEINEIBEISHOUQUANXIANGMUDEJIEGUOBAOGAO。

③SHIYANZHONGXINZHUREN(XIQUANZHUANYESHOUQUANQIANZIREN)QIANFASHIYANZHONGXINJIANCEFANWEINEISUOYOUTONGGUOJILIANGRENZHENGXIANGMUDEJIEGUOBAOGAO。

④SHIYANZHONGXINBUDEZIXINGZHIDINGSHOUQUANQIANZIRENDEDAILIRENYUAN。

4.SHIYANZHONGXINKONGZHIYAODIAN

SHOU QUANQIANZIRENBIXUJUBEIXIANGYINGDEJIAOYUBEIJINGHEGONGZUOJINGLI,YUJIANYANJIANCEJISHUJINMIJIECHU,SHUXIYEWU,ZHANGWOYOUGUANYIQISHEBEIDEZHUANGTAI,SHUXISUOCHENGDANQIANZILINGYUXIANGYINGJISHUBIAOZHUN、JIANYANJIANCEFANGFA HEGUICHENG,SHUXIJIANCEBAOGAOCHANSHENGDEQUANGUOCHENGHEGUANJIANCHENGXU,SHUXI《PINGSHENZHUNZE》、BIAOSHISHIYONGJIQIXIANGGUANFALVFAGUIHEJISHUWENJIANDEYAOQIU,NENGGOUDUIJIANYANJIANCEJIEGUOJINXINGKEXUEDEFENXIYUPINGJIA, BINGJINGKAOHEHEGE。

5.SHOUQUANQIANZIRENKAOHEYAOQIU

SHIYANZHONGXINSHOUQUANQIANZIRENKAOHEYAOQIURUXIA:

①YAOQIUMANZUXIANGYINGDEZIGEGAOJIZHICHENGHUOZHETONGDENGTIAOJIAN,TONGSHIMANZUTEDINGLINGYUDEYAOQIU。

②SHUXIJIANCE、BIAOZHUN、FANGFA、CHENGXU,DUIZIJIXINGYEDEBIAOZHUN、FANGFASHIFENSHUXI。

③DUIJIANCEJIEGUOZUOCHUZHENGQUEDEPINGJIA,BINGPANDUANJIEGUODEZHENGQUEXING、BAOGAOQIANSHUFUHEGUIDINGYAOQIU。

④SHOUQUANQIANZIRENSHUXIZHANGWOSHIYANSHICELIANGJIEGUODEBUQUEDINGDU。

⑤SHUXISHEBEIWEIHUBAOYANG、SHEBEIXIAOZHUNDEYAOQIU、ZHANGWOSHEBEIXIAOZHUNZHUANGTAI。ZHIYOULEJIESHEBEI,CAINENGGENGHAODIZUOHAOSHIYAN,CHUJUZHUNQUEDEJIEGUO。

⑥SHUXI《PINGSHENZHUNZE》HEXIANGGUANFALVFAGUI、ZHENGCEDEYAOQIU。

⑦SHUXIHUODEZIZHIRENDINGDEJIGOUYIWU,ZHANGWOSHOUQUANQIANZIRENDEZHIZEQUANXIAN。

⑧SHUXIYOURENDINGBIAOSHIJIANCEBAOGAOHUOSHIYONGGUIDING,BUKELUANYONGRENDINGBIAOSHI,ZHUNQUEZHANGWOCMABIAOSHIDESHIYONGGUIDING。

⑨ZAIBAOZHENGJIANYANJIANCEGONGZUODEGONGZHENGXINGHEDULIXINGDENGFANGMIAN,YOUXIANGYINGDEGUANLIZHIQUAN,BINGQINGZHENGLIANJIE,BUSHOURENHEBUZHENGDANGJINGZHENG、LIYIGANRAO。

⑩ ZAISHOUQUANQIANZIRENZHIQUANFANWEINEICONGYE,DUIQIQIANFADEBAOGAOYOUZUIZHONGJISHUSHENCHAZHIZE。BUDEQIANSHUBUFUHEYAOQIUDEJIEGUOBAOGAO,ZECHENGBAOGAOBIANXIERENYUANXIUGAIZHIZHIDADAOYAOQIU。DUIYUBUFUHERENDINGYAOQIUDEJIEGUOHEBAOGAOJUYOUFOUJUEQUAN。

四、对《评审准则》4.2.4条款的现场审核思路

JIEHEDUISHUILIXINGYESHIYANSHIDESHENHEJINGYAN,GELEIZHUANYEPINGSHENYUANKECANKAOYIXIASILUSHISHIXIANCHANGSHENHE。

1.PINGSHENSHOUQUANQIANZIRENDEZHIZEQUANXIAN

①CHAKANSHOUQUANQIANZIRENDEZHIZEQUANXIANSHIFOUMINGQUE、SHIFOUFUHE《PINGSHENZHUNZE》YAOQIU。

②SHENHESHOUQUANQIANZIRENDEJISHUDANGAN,CHAYANQINENGLISHIFOUFUHEYAOQIU,SHIFOUJUBEIXIANGYINGDEJIAOYUBEIJINGHEGONGZUOJINGLI。

③CHAJIANYANJIANCEBAOGAOHUOZHENGSHUSHEJIDEXIANGMUSHIFOUMANZUGAISHOUQUANQIANZIRENDESHOUQUANFANWEI。

④CHAKANSHIFOUYOUFEISHOUQUANQIANZIRENSHIFOUCUNZAIQIANFAJIANYANJIANCEBAOGAOHUOZHENGSHUDEXINGWEI,CHAKANBUFUHECIGUIDINGDEJIANCEBAOGAOXIANGGUANJILU。ZHEISHIYOUYUMUQIAN,BUFENYINYEWULIANGDA,JIANCESHIJIANJINZHANG,SHIYANSHIQUEFASHOUQUANQIANZIREN,JINGCHANGYOUFEISHOUQUANQIANZIRENDAIQIANJIANCEBAOGAO。

2.PINGSHENSHOUQUANQIANZIRENDECHENGXINYUGONGZHENGXING

ZHONGDIANSHENHENENGFOUYOUXIAOFANGZHIRENHEYOUSUNDULIXINGHECHENGXINDUDEHUODONG,NENGFOUYOUCUOSHIFANGZHIRENHEXINGSHIDESHANGYEHUILU。

SHENHESHIYANGUOCHENGHEJIEGUOBAOGAOZHENGSHISHIFOUANZHAO《PINGSHENZHUNZE》4.2.4TIAOKUANDEYAOQIUZHIYE。SHENHESHIFOUYOUHUIBIZHIDUHUOGUIDINGHEXIANGYINGJILU。SHOUQUANQIANZIRENZAIJINGJI、JISHUSHANGYUBEIJIANDANWEIWUZHIJIEZERENHELIHAIGUANXI,CHAYANYUDAOCILEIWENTI,SHIFOUANZHAOSHIYANZHONGXINDEHUIBIZHIDUHUOGUIDINGZHIXING,SHENHEXIANGGUANJILU。

3.PINGSHENRENYUANGUANLIGUIFANHECUOSHI

①SHENHESHIFOUJUYOUSHOUQUANQIANZIRENPINGJIAKAOHEJIZHI,ZHIDUSHIFOUFUHE《PINGSHENZHUNZE》JIZUZHISHIJIQINGKUANG。

②PINGSHENSHOUQUANQIANZIRENDERENYUANDANGAN,CHAKANNIANDUPEIXUNJIHUA,CHAKANPEIXUNSHIJIAN、PEIXUNNEIRONG,SHIFOUDUIXINBANBUDEXIANGGUANJISHUGUIFANJINXINGLEPEIXUN,BINGCHAYANPEIXUNXIAOGUOYOUXIAOXINGDEPINGJIAJIELUN。

③PINGSHENSHIFOUANZHAOSHIYANZHONGXINSHOUQUANQIANZIRENKAOHEYAOQIUJINXINGLENIANDUKAOHE,ZHONGDIANSHENHESHOUQUANQIANZIRENDEZHUANYEXING。

④PINGSHENSHOUQUANQIANZIRENSHIFOUCUNZAITONGSHIZAILIANGGEJIYISHANGJIANYANJIANCEJIGOUCONGYEDEWEIGUIXINGWEI,JIANCHASHIYANSHISHIFOUYOUDUIRENYUANGUANLIGUIDINGHECUOSHI。

PINGSHENYUANZAIXIANCHANGSHENHESHI,BUNENGJIANDANDIKANDAOYOUYIGESHOUQUANQIANZIRENDEZHIZEQUANXIANGUIDINGJIKE,ERYAOTONGGUODUISHOUQUANQIANZIRENDEJIANYANJIANCEZHIYEQUANGUOCHENGZHONG,ZHUYIXUNZHAOKEGUANZHENGJU。

五、结语

DUI SHOUQUANQIANZIRENDEGUANZHUYUKONGZHIGUANLIZAIJIANYANJIANCEJIGOUSHISHISHENHEGUOCHENGZHONGSHIGEZHONGDIAN。PINGSHENYUANKEYIANZHAOSHANGSHUSHENHESILUJINXING,YEKEYUQITATIAOKUANSHENHETONGSHIJINXING。GENJUSHENHEGUOCHENGSHOUJIDEZHENG JU,DUIZHAOSHENHEZHUNZEJINXINGXITONGDEFENXI,ZUOCHUZONGHEPANDUAN,KANSHIFOUFUHE《PINGSHENZHUNZE》4.2.4TIAOKUANDEYAOQIU。MUQIAN,HENDUOPINGSHENJIGOUDEPINGSHENYUANDUI《PINGSHENZHUNZE》4.2.4TIAOKUAN DESHENHELIUYUXINGSHI,RENWEISHIYANSHIZHIYAOSHEZHILESHOUQUANQIANZIRENJIFUHEYAOQIU,SHUYUDUISHOUQUANQIANZIRENDEKEXUEKAOHEYUPINGDING,BULIYUSHIYANSHIZHILIANGGUANLIDECHIXUGAIJIN。DUIYUBUFENSHIYANSHIRENGCUNZAI FEISHOUQUANQIANZIRENQIANFAJIANYANJIANCEBAOGAOHUOZHENGSHUDEWEIFAWEIGUIXINGWEI,ZHEIZHONGXIANXIANGJIDAIJIANGUANBUMENZHIDINGYOUXIAOCUOSHIJINXINGJIUZHENGHEJIAYIJIEJUE。