KOLAS-G-020 1.. KS Q ISO/IEC17025 /., KS Q 9000 3.,.. 2.. ( ). KS Q ISO/IEC 17000 - VIM VIML ILAC-P10 ILAC KS P ISO 15189 - KS P ISO 17511 - - KS Q ISO/IEC 17025 1.. KS Q ISO/IEC17025, KS P ISO 15189, KS Q ISO/IEC 17020, KS A ISO GUIDE 34., KS Q ISO 9001 3.,.. 2.,. KS Q ISO/IEC 17000 - VIM ILAC-P10 ILAC KS P ISO 15189 - KS P ISO 17511 - - KS Q ISO/IEC 17025 (KOLAS) (1)/(16)
KS Q ISO/IEC 17011 APLAC MR001 3. 3.1 (Measurement) 3.2 (Measurand) 20 3.3 (Influence quantity) 1) 2) 3) 3.4 (Measuring instrument). 3.5 (material measure), KS Q ISO/IEC 17011 KS Q ISO/IEC 17020 KS A ISO GUIDE 34 3. 3.1 (Metrological Traceability),. 1.,. 2. ISO/IEC 17025:2005 ISO 15189:2012 VIM,. 3.2 (Metrological Traceability Chain) 3.3 (Metrological Traceability to a Measurement Unit) SI. 3.4 (Joint Committee for Traceability in Laboratory Medicine) CIPM, IFCC ILAC 3.5 (National Measurement Institute) (NMI) (Designated Institutes) ILAC P10 ILAC P10 (KOLAS) (2)/(16)
,. 1).. 2) ( ) 3) 4) 5) 6) 3.6 (Calibration) 3.6 (Accredited Laboratory), 1.. 2.. 3.. 3.7 (Testing),,,,, 3.7 (Uncertainty of Measurement), 1.,, ( ). ILAC P10 2..,.,. 3., (KOLAS) (3)/(16)
. 3.8 (Measurement Standard) 3.8 (Measuring Instrument),,, 1) 1 kg 2) 100 Ω 3) 4) 5) 6) 1. (collective standard). 2., (group standard). 3.9 ()(International measurement standard), 3.9 (Nominal Property),, [ 1] [ 2] [ 3] [ 4] ISO [ 5] [ 1]. [ 2]. ILAC P10 ILAC P10 3.10 ()(National measurement standard) 3.10 (Calibration), ( ILAC P10 ) ( ) (KOLAS) (4)/(16)
, 1.,,,,.. 2.. 3.. 3.11 1 (Primary standard) 3.11 (In-House Calibration), 3.12 (Reference standard),,,. 3.12 (RM) 1..,. 2. ILAC P10,. 3.. [ 1] : a). b) (KOLAS) (5)/(16)
c) [ 2] : a) b) DNA c) 19-3.13 (RM),,,,.,,,. 4.. [ 1], [ 2] [ 3] 5.. (WHO) (IU). 6.. 7., (Accred. Qual. Assur.:2006) [45]. 8. ISO/REMCO, (ISO 15189:2007, 3.4),. 3.13 (CRM), 1..(ISO 31:2000 ). 2. ISO Guide 34 ISO ILAC P10 (KOLAS) (6)/(16)
Guide 35. 3... 4..(Accred. Qual. Assur.:2006)[45]. 5. ISO/REMCO (Accred. Qual. Assur.:2006)[45],. 3.14 (CRM) 3.13,,. 1. (batch),. 2..,,,.. 3. " (VIM)". 4. RM CRM,,., (KOLAS) (7)/(16)
(WHO). 3.15 (Metrological Traceability),. 3.1 1. (traceable). 2.. 3.16 (Uncertainty of measurement) 3.7, 1.,, ( ). 2..,.,. 3.,,. 4. 4.1 SI.,, (consensus standard) /. 4.2 1) 4. 4.1 ( : ),, /. (4.1~4.14) ILAC P10 4.2,, (SI) ILAC P10. (KOLAS) (8)/(16)
2),, ( 4.3 ) 4.3 / ; ( ). 1) KOLAS 2) KRISS() 3) CIPM-MRA NMI 4) KOLAS MRA-Partner() 5) KOLAS MRA-Partner NMI 4.4 / /,. 1) 2) 3), 4.5 KOLAS KS Q 9000 KS Q ISO/IEC 17025.. 4.3..,. ILAC P10. 4.4 ILAC G24:2007( ). 4.5,,. KOLAS.(ILAC P10 policy 1, 2, 3) (1) CIPM MRA / NMI (2) ILAC MRA / (3) CIPM MRA / NMI (4) ILAC MRA ILAC P10 ILAC P10 4.6 4.5 (1) (2) ILAC P10 (KOLAS) (9)/(16)
. 4.5 (3) (4) 4.5 (1) (2). 4.5 (3) (4), KOLAS. (1) 4.5 (1) (2) NMI, (2) (ISO/IEC 17025 5.4.5) (3) (ISO/IEC 17025 5.4.6) (4) (ISO/IEC 17025 5.6) (5) (ISO/IEC 17025 5.9) (6) (ISO/IEC 17025 5.2) (7) (ISO/IEC 17025 5.3) (8) /(ISO/IEC 17025 4.6.4, 4.14) 4.7,,,, KOLAS [ 2] ( ). 4.8 4.5 (1)~(4). ISO/IEC 17025 5.6.2.1.2., KOLAS. SI., ILAC P10.(ILAC P10 policy 4) - (CRM) - / (KOLAS) (10)/(16)
,. 4.9 4.5 (1)~(4). (1) (2) (3) ILAC P10 (4) (5),, (6),, 4.10, ILAC P10 4.5~4.8.(ILAC P10 policy 5) 4.11, KOLAS.(ILAC P10 policy 6) 4.12 NMI BIPM KCDB, ISO Guide 34:2009 RMP CRM. (ILAC P10 policy 7) 4.13 JCTLM(Joint Committee for Traceability in Laboratory Medicine) CRM. (ILAC P10 policy 8) 4.14 RM CRM. RM CRM ISO/IEC 17025:2005 4.6.2 ISO/IEC 15189:2012. ILAC P10 ILAC P10 ILAC P10 ILAC P10 (KOLAS) (11)/(16)
6.2.,,. SI, SI 1 1. 1. 1.,,. 6.4 ( )... (ILAC P10 policy 9) 6.2,,. SI, SI 1 1. 1. 6.4 ( )..., 1,, 1. / 2. 7. 7. ( 248 ) ( 248 ), 2019 02 14, 2019 10 00.. (KOLAS) (12)/(16)
1 ( ). 1 ( ). 2 () 2 () ( 2012-0061, 2012.2.17), ( 2016-42, 2016.2.15).,. [ 2] [ 2] 1. ( ) 1. ( ) 1.1 1.1.. 1.2, 1.2,.. 2. 2. 2.1? 2.1? 2.2 (natural constants) 2.2 (natural constants)?? 3. 3. 3.1? 3.1.1? 3.1.2? 3.1? 3.1.1? 3.1.2? (KOLAS) (13)/(16)
3.2 3.1.1 3.1.2? 3.2.1? 3.2.2? 3.2.3? 4. 4. 3.2. 3.2. 4.1,, 4.1,,?? 4.2 4.2,,?? 4.3? 4.4 ( )? 4.5? 4.6? 4.7? 4.8,? 4.9,? 5. 5.1? 5.2? 5.2? 5.3, 5.3,,? 3.2 3.1.1 3.1.2? 3.2.1? 3.2.2? 3.2.3? 4.3? 4.4 ( )? 4.5? 4.6? 4.7? 4.8,? 4.9,? 5. 5.1?,? (KOLAS) (14)/(16)
5.4 - -,? 5.5? 5.5? 5.6 5.6?? 6. 6.1 (self-calibration)"? 6.1.1? 6.1.2? 6.1.2? 6.2 6.2? 6.2.1? 6.2.2? 6.2.2? 6.2.3?( 6.2.3?( ) ) 6.3? 6.3.1 (zero setting)? 6.3.2? 6.4? 6.4? 6.4.1 6.4.1?? 6.5 ( 6.5 ( )? )? 6.5.1,? 6.5.2? 6.5.3 6.5.2 KS Q ISO/IEC 17025? 5.4 - -,? 6. 6.1 (In-House calibration)"? 6.1.1?? 6.2.1? 6.3? 6.3.1 (zero setting)? 6.3.2? 6.5.1,? 6.5.2? 6.5.3 6.5.2 KS Q ISO/IEC 17025? (KOLAS) (15)/(16)
6.5.4 KS Q ISO/IEC 17025? 6.6? 6.6.1? 6.7? 6.7.1? 6.7.2? 6.5.4 KS Q ISO/IEC 17025? 6.6? 6.6.1? 6.7? 6.7.1? 6.7.2? 7. 7. 7.1 7.1?? 7.2? 7.2? 7.3 7.3?? 7.4, 7.4,?? 7.5 7.5 (KOLAS) (16)/(16)