JIS Q 17025(ISO/IEC 17025(IDT))
JIS Q17025(ISO/IEC 17025(IDT)) --- --- JNLA JCSS ISO/IEC 17025 JIS Q 17025 IAJapan ILAC APLAC JIS Q17011 ISO/IEC 17011 MRA ILACAPLAC MRA IAJapan (3) JNLAJCSS (4) testing and calibration laboratory laboratory testing
JIS Q17025:2005 (ISO/IEC 17025 :2005(IDT)) JIS Q17011 :2005 (ISO/IEC 17011 :2004(IDT)) JIS Q190112003 (ISO 19011:2002(IDT)) /
2005 2 ISO/IEC 17025:2005General requirements for the competence of testing and calibration laboratories / ISO/IEC 17025:1999 (JIS Q 17025:2000) ISO/IEC Guide 25:1990 ( JIS Z 9325:1996 ) EN 45001:1989 JIS Q17025:2000JIS Z9901:1998JIS Z9902:1998 JIS Q9001:2000 JIS Q17025:2000 JIS Q 9001:2000 4 5 JIS Q 9001 JIS Q 9001 JIS Q 9001 JIS Q 9001 JIS Q 9001 ISO/IEC 17025:1999 ISO/IEC Guide 25:1990 1995 ISO 9000 (1994 ) Guide 25
Guide 25 ISO 9000 2000 Guide 25 ISO 9001:1994 ISO 9001 ISO/IEC 17025:2005 ISO 9001:2000 1.1 1.2 1.3 ( ) 1.4 1 2 1.5 1.6 JIS Q 9001 A JIS Q9001 JIS Q9001 1
JIS Q 17011 B 2 JIS Q 17011 3 ISO/IEC 17025:2005General requirements for the competence of testing and calibration laboratories (IDT) (IDT) ISO/IEC Guide 21 1. 1999 ISO 9001 1.3 shall should 1.4 JIS Q17011(ISO/IEC 17011) ILAC ILAC G14 JNLAJCSS 2005 (client) (customer) (client) ISO 9000 1.5 1.6 ISO 9001 ISO 9001 ISO 9001
1. 1 (should) ( ) JIS Q17000 ISO/IEC 17000:2004, Conformity assessment general principles IDT Vocabulary and VIM, International vocabulary of basic and general terms in metrology, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML VIM 2. GUM JIS Q17000VIM JIS Q 9000 JIS Q17000 JIS Q9000 JIS Q17000 VIM 3.
4 4.1 4.1.1 4. 4.1.1 ( ) (in-house lab) 4.1.4 (4.1.5 ) (3) ISO 9000 (4) 4.1.2 4.1.3 4.1.3 JNLA JNRP22) JCSS JCRP22) (3) (4.1.5e) )
(5.5 ) 4.1.4 4.1.4 4.1.5 b) (determination) ( (inspection) ) 1.2 (3) 2 impartial 4.1.5 a) 5.2 b) c) d) e) f)
g) h) i) 1 j) k) 4.1.5 a) 2005 ISO 9001:2000 Plan Do Check Act (personnel) 4.1.5 b) (management) (3) (4.1.4 ) (4) 4.1.5 c) 4.1.5 d)
( ) integrity ( ( ) 4.1.5 f) (5.2.4 ) (3) JNLA JCSS 4.1.5 g) 4.1.5 h) (3) (technical management) 4.1.5 i) (3) (quality manager) (4) ISO 9001 (management representative) 4.1.5 j) 4.1.5 k)
2005 ISO 9001:2000 6.2.2 d) 4.1.6 4.1.6 2005 ISO 9001:2000 5.5.3 ISO 9000:2000 (3) 4.2 4.2.1 4.2.1 (3) JIS (4)
(5) (5.4.1 ) 4.2.2 a) b) c) d) e) 4.2.2 2005 (3) objectives (4) 4.2.5 (5) (6) objectives ( ) (7)
4.2.2 c) 1999 2005 4.2.2 e) 1999 2005 ISO 9001:2000 4. 4.1 P-D-C-A 4.2.3 4.2.4 4.2.3 2005 ISO 9001:2000 5. 5.1 a) b) c) d) e) ISO 9001 a) e) 4.2.4 4.2.3 ISO 9001:2000 5. 5.1 a)
4.2.5 4.2.6 4.2.7 integrity 4.2.7 2005 ISO 9001:2000 5.4 5.4.2 b) IS0 9000:2000 control 4.3 4.3.1 5.4.7 4.13 4.3.1 4.3
( ) (4.3.2.1 ) (3) (4) (5.5 ) 5.5 (5 4.3.2 4.3.2.1 / 4.3.2.2 a) b) c) d) 4.3.2.3 / 4.3.3 4.3.3.1 4.3.3.2 4.3.3.3 initial 4.3.3.4
4.3.2.1 4.3.2.2 d) 4.13 4.3.3 function 4.4 4.4.1 a) 5.4.2 b) c) 5.4.2 / 4.4.2
4.4.3 4.4.4 4.4.5 4.4.1 (a) (b) (c) ( : ) 4.5 4.5.1 4.5.2 4.5.3
4.5.4 4.5.1 (3) 4.6 (4) (5) (6) JIS Q 17011 (7) JNLA JCSS (8) JCSS JCRP21) (9) ISO 9001 4.1 4.5.2 (5.10.6 ) 4.5.4 (4.5.1 ) IAJapan 4.6 4.6.1 4.6.2
4.6.3 output type class grade 4.6.4 4.6 5.5 5.6 (3) ISO 9001 4.6.2 specified requirements requirements of this International Standard (3) 4.6.4 JIS Q 0034 4.7 4.7.1
a) b) 4.7.2 4.7.1 4.1.5 c) 4.7.2 1999 4.7 3. 2005 4.7.2 ISO 9001:2000 8.2 8.2.1 4.15 4.8 4.11 4.8 (3)
(4) (5) (4.11.5 ) 4.9 4.9.1 a) b) c) d) e) 4.9.2 4.11 4.9.1 (3) (4) d) (5) ISO 9001
4.10 4.10 2005 ISO 9001:2000 8.5 8.5.1 continually 4.11 4.11.1 4.11.2 4.11.3
4.11.4 4.11.5 4.14 4.11.2 4.9.1a) 4.12 4.12.1 4.12.2 4.12.1 4.13 4.13.1 4.13.1.1
4.13.1.2 4.13.1.3 4.13.1.4 4.13.1.3 (4.1.5c) ) 4.13.1.4 4.13.2 4.13.2.1 5.4.7 4.13.2.2
4.13.2.3 4.13.2.1 (3) defined PL 10 6 (4) (5.4.7.2 ) 4.13.2.3 GLP / / 4.14 4.14.1 1 1
4.14.2 4.14.3 4.14.4 4.14.1 ( ) (3) (4) (5) (6) ISO/IEC 17025 (7) IAJapan ( ) (8) JIS Q19011 (9) (10) APLAC APLAC TC002 4.14.3 (4.15.1 ) 4.15 4.15.1
12 1 4.15.2 4.15.1 4.14 (3) (4) APLAC APLAC TC003 a) b) c) d) e) f) g)
h) i) j) k) l) m) n) (5) 2005 4.2.3 4.10 4.15.2 5 5.1 5.1.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.1.2 5.1.1 5.2 5.2.1 /
5.2.2 5.2.3 5.2.4 5.2.5
5.2.1 5.2.1 5.2.2 2005 ISO 9001:2000 6.2 6.2.2 c) 5.2.3 5.2.4 5.2.5 / IAJapan (3) (4)
5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 5.3.1 5.3.2 5.3.3 separation cross-contamination (3) 5.3.4
5.3.5 housekeeping 5.3 1.5 5.4 5.4.1 4.3 5.4.1 5.4.2
5.4.2 JCSS 5.4.3 5.4.4 a) b) c) type d) e)
f) g) h) i) j) k) 5.4.4 (consensus standard) JCSS IAJapan JNLA JIS (3) 5.4.3 5.4.4 5.4.5 5.4.5.1 5.4.5.2
5.4.5.3 cross-sensitivity 5.4.5.1 5.4.5.2 5.9 b) 5.4.6 5.4.6.1 5.4.6.2 performance scope
5.10 5.4.6.3 JIS Z8402 GUM 5.4.6.1 JCSS (best measurement capability) APLAC APLAC TC005 EURACHEM/CITAC Guide CG4 (3) (testing) 5.6 5.4.6.2 (testing) (3) 5.4.7 5.4.7.1 5.4.7.2 a) b) c)
configuration 5.4.7.2 a 5.4.7.1 5.4.7.2 5.4.7.2 (5.5.2 ) ( ) 5.4.7.2 a) 5.4.7.2 b) SI 5.5 5.5.1
5.5.1 furnish ( ) (3) 5.5.2 / 5.6 5.5.2 (3) (4) (5.6.2.1 ) 5.5.3 5.5.4 5.5.5 a) b) c) 5.5.2 d) e)
f) g) h) 5.5.5 ( ) 5.5.6 5.5.6 5.5.7 4.9 5.5.8 5.5.8 5.5.5 5.5.9
5.5.10 5.5.11 5.5.12 5.5.12 5.6 5.6.1 5.6.1 SI IAJapan ILAC ILAC G2 URP23 (3) (4) GUM (5) ILAC ILAC P10 (ISO 9001) 5.6.2
5.6.2.1 5.6.2.1.1 SI SI SI SI SI SI 5.10.4.2 SI VIM 1993 6.4 SI CGPM CIPM SI SI SI BIPM 5.6.2.1.2 SI
5.6.2.1.1 SI ILAC ILAC P10 2.(b) IAJapan JNLA 5.6.2.2.1 (3) JCSS IAJapan URP23 URP23 IAJapan 5.6.2.1.2 5.9.1 b) 5.6.2.2 5.6.2.2.1 5.6.2.1 5.6.2.1 5.6.2.2.2 SI 5.6.2.1.2 / 5.6.2.2.1 5.10.3.1 c) (testing) 5.6.2.1 (3) JNLA IAJapan (URP23) NMI 5.6.3 5.6.3.1 5.6.2.1
5.6.3.2 SI internal 5.6.3.3 5.6.3.4 5.6.3.1 5.6.3.2 5.6.3.3 5.7 5.7.1
5.7.2 5.7.3 5.7.1 5.8 5.8.1 5.8.1 5.8.2
5.8.2 5.8.3 5.8.4 5.8.4 (3) 1.5 5.9 5.9.1 a) b)
c) d) e) 5.9.1 5.9.1 a) 5.9.1 b) ISO/IEC 170117.15 (3) APLAC/MR001 APLAC/MRA MR001 3.3 (5.4.5.2 ) (4) JNLA JCSS APLAC (5) APLAC IAJapan 5.9.1 d) retained 5.9.1 e)
5.9.2 5.9.2 2005 ISO 9001:20008.4 ISO 9001:20008.4 a) b) c) d) 4.9 4.10 4.11 4.12 5.10 5.10.1 1 5.10.2 5.10.35.10.4 5.10.2 5.10.4 5.10.1 ISO/IEC 17011(JIS Q 17011) ISO/IEC 17011 8.1.1 JNLA JNRP21) JCSS JCRP21) (3) ILACAPLAC MRA IAJapan
IAJapan ILAC APLAC 5.10.2 a) b) c) d) e) f) g) h) i) j) k) 5.10.2 5.10.3 5.10.4 5.10.2 c) Page 1of 3pages 1/3 5.10.2 d) 5.10.2 e) 5.10.2 f)
5.10.2 h) 5.10.2 i) 5.10.2 j) (3) (4) 5.10.2 k) 5.10.2 k) 5.10.3 5.10.3.1 5.10.2 a) b) c) d) 5.10.5 e) 5.10.3.2 5.10.2 5.10.3.1 a) b) c) d) e) f)
5.10.3 JIS JNLA JIS 5.10.4 5.10.4.1 5.10.2 a) b) c) 5.6.2.1.1 2 5.10.4.2 5.10.4.3 5.10.4.4 5.10.4 (a) (b) 5.10.5
JIS Q 17020 JIS Q 0065 5.10.5 (3) JIS 1 5.10.4.2 5.10.4.4 5.10.6 5.10.6 4.5.3 JCSS JCSS JCRP21) 5.10.7 5.4.7 5.10.8
5.10.9 5.10.9
A JIS Q9001:2000 ISO/CASCO WG25 A.1JIS Q9001:2000 (JIS ) JIS Q9001 JIS Q17025 1 1 2 2 3 3 4.1 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.2 4.2.1 4.2.2 4.2.34.2.4 4.2.1 4.2.2 4.2.3 4.3.1 4.2.2 4.2.2 4.2.3 4.2.4 4.2.5 4.2.3 4.3 4.2.4 4.3.14.12 4.13 5.1 4.2.24.2.3 5.1 a) 4.1.24.1.6 4.2.4 5.1 b) 4.2.2 5.1 c) 4.2.2 5.1 d) 4.15 5.1 e) 4.1.5 5.2 4.4.1 5.3 4.2.2 5.3 a) 4.2.2 5.3 b) 4.2.3 5.3 c) 4.2.2 5.3 d) 4.2.2 5.3 e) 4.2.2 5.4.1 4.2.2 c) 5.4.2 4.2.1 5.4.2 a) 4.2.1 5.4.2 b) 4.2.1 4.2.7 5.5.1 4.1.5 a) f) h) 5.5.2 4.1.5 i) 5.5.2 a) 4.1.5 i) 5.5.2 b) 4.11.1 4.1.5 i) 5.5.2 c) 4.2.4 5.5.3 4.1.6 5.6.1 4.15
A.1 JIS Q9001:2000 JIS JIS Q9001 JIS Q17025 5.6.2 4.15 5.6.3 4.15 6.1 a) 4.10 6.1 b) 4.4.1 4.7 5.4.2 5.4.3 5.4.4 5.10.1 6.2.1 5.2.1 6.2.2 a) 5.2.25.5.3 6.2.2 b) 5.2.15.2.2 6.2.2 c) 5.2.2 6.2.2 d) 4.1.5 k) 6.2.2 e) 5.2.5 6.3.1 a) 4.1.3 4.12.1.2 4.12.1.3 5.3 6.3.1 b) 4.12.1.4 5.4.7.2 5.5 5.6 6.3.1 c) 4.6 5.5.6 5.6.3.4 5.8 5.10 6.4 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 7.1 5.1 7.1 a) 4.2.2 7.1 b) 4.1.5 a) 4.2.1 4.2.3 7.1 c) 5.45.9 7.1 d) 4.1 5.4 5.9 7.2.1 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 5.4 5.9 5.10 7.2.2 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 5.4 5.9 5.10 7.2.3 4.4.2 4.4.4 4.5 4.7 4.8 7.3 5 5.4 5.9 7.4.1 4.6.1. 4.6.2 4.6.4 7.4.2 4.6.3 7.4.3 4.6.2 7.5.1 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 7.5.2 5.2.5 5.4.2 5.4.5 7.5.3 5.8.2 7.5.4 4.1.5 c) 5.8 7.5.5 4.6.1 4.12 5.8 5.10 7.6 5.45.55.6 8.1 4.10 5.4 5.9 8.2.1 4.10 8.2.2 4.11.54.14 8.2.3 4.11.5 4.14 5.2 5.3 5.4 5.5 5.7 5.8 5.9 8.2.4 4.5 4.6 4.9 5.5.2 5.5.9 5.8 5.8.3 5.8.4 5.9 8.3 4.9 8.4 4.105.9 8.5.1 4.104.12 8.5.2 4.114.12 8.5.3 4.9 4.11 4.12 JIS Q17025 JIS Q9001
B B.1 B.2 B.3 B.4 B.5
[1] JIS Q0030:1997 :ISO Guide 30:1992, Terms and definitions used in connection with reference materials (IDT) [2] JIS Q0031:2002 :ISO Guide 31:2000, Reference materials -Contents of certificates and labels (IDT) [3] JIS Q0032:1998 :ISO Guide 32:1997, Calibration in analytical chemistry and use of certified reference materials (IDT) [4] JIS Q0033:2002 :ISO Guide 33:2000, Uses of certified reference materials(idt) [5] JIS Q0034:2001 :ISO Guide 34:2000, General requirements for the competence of reference material producers (IDT) [6] JIS Q0035:1997 :ISO Guide 35:1989, Certification of reference materials -General and statistical principles (IDT) [7] JIS Q 0043-1:1998 :ISO/IEC Guide 43-1:1997, Proficiency testing by interlaboratory comparisons -Part 1: Development and operation of proficiency testing schemes (IDT) [8] JIS Q 0043-2:1998 :ISO/lEC Guide 43-2:1997, Proficiency testing by interlaboratory comparisons - Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies (IDT) [9] JIS Q0065:1997 :ISO/IEC Guide 65:1996, General requirements for bodies operating product certification systems (IDT) [10] JIS Q 17011:2005 :ISO/IEC 17011:2004, Conformity assessment -General requirements for accreditation bodies accrediting conformity assessment bodies (IDT) [11] JIS Q17020:2000 :ISO/IEC 17020:1998, General criteria for the operation of various types of bodies performing inspection (IDT) [12] JIS Q19011:2003 :ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing (IDT) [13] JIS Q9000:2000 :ISO 9000:2000, Quality management systemsfundamentals and vocabulary (IDT) [14] JIS Q9001:2000 :ISO 9001:2000, Quality management systems -Requirements (IDT) [15] JIS Z8402-1:1999 :ISO 5725-1:1994, Accuracy (trueness and precision) of measurement
methods and results -Part 1:General principles and definitions (IDT) [16] JIS Z8402-2:1999 :ISO 5725-2:1994, Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of astandard measurement method (IDT) [17] JIS Z8402-3:1999 :ISO 5725-3:1994, Accuracy (trueness and precision) of measurement methods and results - Part 3:Intermediate measures of the precision of a standard measurement method (IDT) [18] JIS Z8402-4:1999 :ISO 5725-4:1994, Accuracy (trueness and precision) of measurement methods and results -Part 4: Basic methods for the determination of the trueness of a standard measurement method (IDT) [19] JIS Z8402-6:1999 :ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results -- Part 6: Use in practice of accuracy values (IDT) [20] ISO/IEC Guide 58:1993, Calibration and testing laboratory accreditation systems -General requirements for operation and recognition [21] ISO 10012:2003, Measurement management systems - Requirements for measurement [22] processes and measuring equipment ISO/IEC 90003:2004, Software engineering - Guidelines for the application of ISO 9001:2000 to computer software [23] GUM, Guide to the Expression of Uncertainty in Measurement, issued by BIPM, IEC, IFCC, ISO,IUPAC, IUPAP and OIML [24] Information and documents on laboratory accreditation can be found on the ILAC (International Laboratory Accreditation Cooperation): www.ilac.org ISO/IEC ILAC EA APLAC EURACHEM/CITACGuide CG4