KS A ISO GUIDE 34-2012 General requirements for the competence of reference material producers《参考材料生产商权限的通用要求》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS A ISO GUIDE 34 KS A ISO GUIDE 34:2012 2012 3 29 http:/www.kats.go.krKS A ISO GUIDE 34:2012 : ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2001 10 6 ：2012 3 29 2012-0133 ： ： ( 02-509-7274) (http:/www.kats.go.kr). 10 5 , . KS A ISO GUIDE 34:2012 i . iii 1 1

2、2 1 3 .2 4 .5 4.1 5 4.2 6 4.3 .7 4.4 , .8 4.5 .8 4.6 9 4.7 9 4.8 10 4.9 / .10 4.10 10 4.11 11 4.12 .11 4.13 .11 4.14 12 4.15 13 5 .13 5.1 13 5.2 .14 5.3 14 5.4 15 5.5 16 5.6 .16 5.7 .17 5.8 18 5.9 18 5.10 18 5.11 19 5.12 19 5.13 21 5.14 21 5.15 .22 5.16 23 5.17 .23 5.18 24 A( ) 25 A.1 .25 KS A ISO G

3、UIDE 34:2012 ii A.2 25 B( ) 27 B.1 .27 B.2 .28 C( ) KS Q ISO/IEC 17025 KS A GUIDE 34 .29 35 KS A ISO GUIDE 34:2012 iii 2009 3 ISO Guide 34, General requirements for the competence of reference material producers . KS A ISO GUIDE 34:2012 General requirements for the competence of reference material p

4、roducers 1 1.1 . 1.2 , . , . . 1.3 . . 1.4 . . . 2 . . ( ) . KS A ISO GUIDE 30： 2005, ISO Guide 30, Terms and definitions used in connection with reference materials . KS A ISO GUIDE 31： 2005, ISO Guide 31, Reference materials Contents of certificates and labels . KS A ISO GUIDE 35： 2005, ISO Guide

5、35, Reference materials General and statistical principles for certification . KS A ISO GUIDE 34:2012 2 KS Q 4001： 2005, ISO/IEC Guide 98 3, Uncertainty of measurement Part 3 ： Guide to the expression of uncertainty in measurement(GUM) . KS A 0002： 2004, International vocabulary of basic and general

6、 terms in metrolory(VIM), 1993, BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML . KS Q ISO 9000： 2007, ISO 9000, Quality management systems Fundamentals and vocabulary . KS Q ISO 10012： 2004, ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment . KS P

7、ISO 15189： 2011, ISO 15189, Medical laboratories Particular requirements for quality and competence . KS Q ISO/IEC 17000： 2007, ISO/IEC 17000, Comformity assessment Vocabulary and general principles . KS Q ISO/IEC 17025： 2006, ISO/IEC 17025, General requirements for the competence of testing and cal

8、ibration laboratories . 3 KS Q ISO/IEC 17000, KS Q ISO/IEC 17025, KS A ISO GUIDE 30, KS A ISO GUIDE 35, KS Q ISO 9000 KS A 0002 . ( ) ISO/IEC Guide 99 KS A ISO GUIDE 30 . , “ ” , . 3.1 (reference material producer) , , ( ) 3.2 (subcontractor) , KS A ISO GUIDE 34:2012 3 , , , , ( )(5.3.1 ) 1 , . 2 (s

9、ubcontractor) (collaborator) . 3 , , . 3.3 (production of a reference material) ( ) , , , , (“ ” “ ” ), , . , , , . 3.4 (reference material) RM 1 . 2 . 3 , , . 4 . 5 VIM (ISO/IEC Guide 99： 2007, 5.13) , “ ” , . , ISO/IEC Guide 99： 2007, 5.13 3 “ (nominal property)” . ISO Guide 30:1992/Amd.1： 2008, 2

10、.1 3.5 (certified reference material) CRM 1 . . 2 KS A ISO GUIDE 34 KS A ISO GUIDE 35 . 3 KS A ISO GUIDE 31 . 4 VIM (ISO/IEC Guide 99： 2007, 5.14) ISO Guide 30:1992/Amd.1： 2008, 2.2 KS A ISO GUIDE 34:2012 4 3.6 (commutability of a reference material) 1 , . 2 ( ) . 3 . ISO/IEC Guide 99： 2007, 5.15 3.

11、7 (metrological traceability) , . 1 , . 2 . 3 . . 4 , . . 5 . 6 , , . 7 ILAC , , , , SI , (ILAC-P10:20029 ). 8 “ ” “ ” , “ (sample traceability)”, “ (document traceability)”, “ (Instrument traceability)”, “ (material traceability)” , (“trace” ) . “ (measurement traceability)” . ISO/IEC Guide 99： 200

12、7, 2.41 3.8 (measurement uncertainty) 1 . , . KS A ISO GUIDE 34:2012 5 . 2 ( ) . 3 . A . B . 4 . . ISO/IEC Guide 99： 2007, 2.26 4 4.1 4.1.1 , , . ( , ) . . ( ) , ( ) , , , . 4.1.2 ( ), ( ), ( ) , , . ( ) . . . a) KS A ISO GUIDE 30 b) KS A ISO GUIDE 35 KS A ISO GUIDE 31 c) KS Q ISO/IEC 170251) 1) KS

13、Q ISO/IEC 17025 KS P ISO 15189 . KS A ISO GUIDE 34:2012 6 d) e) . 4.1.3 , , . , , , , , . , , , . . a) ( , , ) b) c) d) e) ( ) f) ( ) g) h) KS A ISO GUIDE 31 i) j) , , k) ( ) l) KS A ISO GUIDE 30 KS A ISO GUIDE 31 KS A ISO GUIDE 35 , . . , ( ) . 4.2 4.2.1 . 4.2.2 ( ) ( ) . 4.2.3 a) , , KS A ISO GUID

14、E 34:2012 7 . b) , . c) . d) , , . e) , , , , . f) , , . g) . h) , ( .) . . i) , . 4.3 4.3.1 ( ) , . , , . “ ” , , , , , , . , , , . 4.3.2 4.3.2.1 . . . 4.3.2.2 . a) . b) , . c) , KS A ISO GUIDE 34:2012 8 . d) . 4.3.2.3 . / , , . 4.3.3 4.3.3.1 , . . 4.3.3.2 , . 4.3.3.3 , . , . 4.3.3.4 . 4.4 , 4.4.1 , . a) , , . b) . c) , . 1 , , , . / . 2 . 4.4.2 . . 4.4.3 . 4.5 4.5.1 . KS A ISO GUIDE 34:2012 9 . 4.5.2 . 5. . 4.5.3 . . . , KS Q ISO/IEC 17025 . KS Q ISO/IEC 17025 .