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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。 |