GOST R 56395-2015 Medical laboratories Reduction of errors through risk management and continual improvement《医学实验室 通过风险管理和持续改进减少错误》.pdf

1、 ISO/TS 22367:2008Medical laboratories Reduction of error through risk management and continual improvement(IDT) 563952015/ISO/TS22367:20081 () -, 42 380 - - 3 27 2015 . 302-4 ISO/TS 22367:2008 . (ISO/TS 22367:2008 Medical laboratories Reduction of error through risk management and continualimprovem

2、ent). - - , 5 1.02012 ( 8). ( 1 ) , -. () . , - (www.gost.ru) , 2015 , - - II 563952015/ISO/TS 22367:20081 12 13 14 .24.1 .24.2 24.3 .24.4 .25 , 36 , 37 48 , . 49 , .510 511 512 5 () .6 () .7 () 8 () ( ) .9 10 563952015/ISO/TS 22367:2008III 15189 , , . 15189 , - . . , - . -. ; , . , . , , ; - , . -

3、. -, , -. , . -, ., , . :) ;b) ;c) ;d) . , 15189, :- ;- ;- ;- . , - . , - , , . , , - .IV 563952015/ISO/TS 22367:2008 Medical laboratories.Reduction of errors through risk management and continual improvement 201606011 15189 - - , . -, 15189.2 - : 9000 . (ISO 9000, Qualitymanagement systems Fundamen

4、tals and vocabulary) 14971:2007 . - (ISO 14971:2007, Medical devices Application of risk management to medical devices) 15189 . (ISO 15189, Medical laboratories Particular requirements for quality and competence) / 73 . . (ISO/IECGuide 73, Risk management Vocabulary Guidelines for use)3 9000, 14971,

5、 15189, / 73, :3.1 (laboratory error): , - , - , , .3.2 (active error): . . 2.1 563952015/ISO/TS 22367:20083.3 (cognitive error): - , - . 1 . 1. 2 (. 1).3.4 (failure modes and effects analysis); FMEA: - , / . 1 , - . 2 .3.5 (latent error): - , . , , - (. 2).3.6 (non-cognitive error): - - . 1 . 1. 2

6、(. 9).3.7 (failure mode and effects analysis): -, .4 4.1 , - .4.2 :- -;- , , ;- .4.3 :- -, ;- - , ;- , ;- - , .4.4 , , .2 563952015/ISO/TS 22367:20085 , , :- ;- ;- ;- . . , - (. ).6 , , . , .) :1) :- ;- ;- ;- ;- ;- -;- ;- ;- ;2) :- ;- ;- ;- ( ). ;3) :- ;- ;- ;- ;- ;- ;b) , :- ;c) :- ;- ;- -;d) :- , , ;) :- ;- ;- .3 563952015/ISO/TS 22367:20087 - .