1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO TS 22367 KS P ISO TS 22367:2009 2009 12 29 http:/www.kats.go.krKS P ISO TS 22367:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2009 12 29 2009-0931 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO TS 22367:2009 . . ii 1 1 2 1
2、 3 .1 4 .2 4.1 .2 4.2 2 4.3 3 4.4 .3 5 , 3 6 , .3 7 .4 8 4 9 , 5 10 .5 11 6 12 6 A( ) 7 B( ) 8 C( ) .9 10 i KS P ISO TS 22367:2009 2008 1 ISO/TS 22367, Medical laboratories Reduction of error through risk management and continual improvement . . . , , . , , . ii KS P ISO TS 22367:2009 Medical labora
3、toriesReduction of error through risk management and continual improvement 1 , KS P ISO 15189 . KS P ISO 15189 . 2 . . ( ) . KS A ISO/IEC Guide 73, KS P ISO 15189, KS Q ISO 9000, ISO 14971： 2007, Medical devicesApplication of risk management to medical devices 3 KS Q ISO 9000, ISO 14971, KS P ISO 15
4、189, KS A ISO/IEC Guide 73 . 3.1 , , . 3.2 2 KS P ISO TS 22367:2009 3.3 , 1 1 2 “ ” “ ” ( 9 ). 3.4 (FMEA) / 1 . 2 “ (bottom-up)” . 3.5 , , ( 2 ) 3.6 1 1 2 “ ” “” ( 9 ). 3.7 4 4.1 / . 4.2 . . (type) . . 2 KS P ISO TS 22367:2009 4.3 . , . , . , . , . 4.4 , . 5 , 5.1 , . 5.2 . ( A ). 6 , , . . a) : : :
5、 ( ) 3 KS P ISO TS 22367:2009 . : . b) , : c) , d) : e) : . . . 7 7.1 . , , , . 7.2 , . . . 8 . a) b) c) d) e) 4 KS P ISO TS 22367:2009 ( B ) ( C ) . 1 FMEA , . ：(PHA), FME(C)A, (FTA), (HAZOP), (HACCP) . ISO 14971： 2007 G . 13, 14, 15, 16, 17, 18 . , , . . 2 . 3 . . 4 , , , . , , , . FMEA . 9 , , .
6、, ( C ). , . 10 FMEA , / . . 5 KS P ISO TS 22367:2009 , , 11 , , , . . . 12 , . ( ) . , . , . 6 KS P ISO TS 22367:2009 A () (FMEA) . FMEA . . / . . FMEA . A.1 . , , , , , , , . : : : : : : A.1 . . , . . . . . . FMEA / . 7 KS P ISO TS 22367:2009 B () B.1 . B.1 . . . . , . , . 8 KS P ISO TS 22367:2009
7、 C () . . . . C.1 . C.1 9 KS P ISO TS 22367:2009 KS A IEC 60812, (FMEA) 17 KS A IEC 61025, (FTA) 18 KS A IEC 61882, (HAZOP) 10 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO TS 22367:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Medical laboratoriesReduction of error through risk management and continual improvement ICS 11.100.01 Korean Agency for Technology and Standards http:/www.kats.go.kr
