ISO17025.PDF

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1 ISO/IEC

2 , 45 / / / / 59 / 510 A( ) ISO/IEC ISO 9001:1994 ISO 9002:1994 B( )

3 1 11 /, / 12 / 1, 2, 3/ ( ` ' ) /, / /,, 13 (note),, 14,, 15 16, / / / ISO 9001, ISO 9002 A ISO 9001 ISO 9002 ISO/IEC ISO 9001 ISO (ISO/IEC 58:1993, 413 ) B 2, ISO/IEC 58

4 2,, ISO IEC ISO 9001: 1994, -,,, ISO 9002: 1994, -, ISO/IEC Guide 2, VIM,, BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML 1, 2, ISO ISO 9001:2000 3, ISO/IEC Guide 2 VIM ISO/IEC Guide 2, /, ISO 8402 ISO 8402, ISO/IEC Guide 2 VIM

5 , / /, / 1 ( ),, 2 3,, 3 / 415 a), /, (52 ) b) /,, c),

6 d),, e),,, f) /,,, g) /,, / h) i), ( ) j) ( ), ,, /,,,,,, 422 ( ) a) /

7 b) c) d) /, e) /, ,, ,,,,,,, / ( ) 1,,,,,,,,,,,,,, 2 / (master list),

8 4322 : a) b),, c), d) 4323 /,,, , ( ) 4332, 4333,, 4334

9 44, 441, / : a),, (542 ) b) c) /, (542 ) 1,,,, 2,,, / /,, (trial test) 3 / 442,, ( : ),, /, ,

10 45 / 451 ( :,, ) ( :, ),, 452, 453, 454 / / /, 462 /, /, 463,,,,,,,, 464 /,,

11 47,, 1 : a) /, b) /,, 2,,, / 3, ( : ), /, 48 (410 ) 49 / 491 / : a) (,, ) b) c) d),

12 e) /,,,,,, 492,,, ,,,,, 4102,,,,, 4103,, 4104

13 4105,, 413, ,,, ,, ,,,,,, 41212, 41213

14 41214 (back-up) , (audit trail),,, /,,, /, 1 2 /, (parameters) (547 ),,,,,,,,, 41222, 41223,,, , /, 4132, / ( ),,,

15 4133, ,, / : , /,,, / :

16 - (52) - (53) - / (54) - (55) - (56) - (57) - / (58) 512 ( ) ( ) /,, , /,,,,, / 1 ( : ), 2,, -,,, - -,, 522,, 523 ( ), ( )

17 524 /, (/ ), - / - /, - -, , /,,,,,,,, / ,, /, / / 532,,,,,,,,,,,, /, / 533, (cross-contamination) 534 / 535

18 54 / 541 / /,,,,, / /,, /,,, (43 ) /,, /,, 542, /, /,,,,,, /, 543

19 / 544, / /, /, : (a) (b) (c) / (d) (e) (f), (g) (h) -,,,, -, -,,, -, - (i) / / (j), (k) , /,,

20 1, 2, ,,, 5453 ( :,,,, /, (robustness) / / (matrix) (cross-sensitivity)) 1,, 2, 3, ( :,,,,,, ) ,,,,, 1 - -

21 - (narrow) 2, (510 ) 5463, 1,,,,, / 2, / 3 ISO 5725 ( ) /,,,,, : a) b) (integrity),, c), / ( :,, ) / 5472a

22 / (, /, / ),, 552,, /, ( ) /, / (56 ) 553 ( ) 554, / 555 / : a) b),, c) (552 ) d), e), f),,,, g), h),, (modification)

23 556, (deterioration),,,, 557,,,, / /, (49 ) 558,, 559,, 5510, 5511, ( : ) 5512 / /

24 ( : ),, /,, /,,,, , (SI), SI 1 SI SI SI (representation) 1 2,, / (51042 ) 1 2 SI 1 (VIM:1993, 64 ), (CGPM) (CIPM) SI 3 1 SI SI 4,

25 5, SI 1 6 7, (BIPM) SI, - (CRM) - / , 5621, 5621, SI /,,, / (56212 ) 563

26 , 5632, SI 5633, 1, 5634,,,,, / (substance),, / 1 /,, ( : ), 2,,

27 , 572,,, /, 573 /,, ( ),, 58 / 581 /, /,,,,, / 582 /, 583 /, / /,, /, / 584,,,,,, 1,, /

28 2 3 /, / 59 / /,,, a) / 2 b) c) / d) e) , /,,,, / ( 1 ),, / 5102,

29 /, 5102, / 1 2, 5102, : a) ( : ` ' ` ') b), / c) ( : ),, d) e) f) /, g), / h), i) / j),, k), /

30 ,, : a), b), / / c), :,,, d), (5105 ) e), , : a) b), (,, ) c),, d) e) f), 5104

31 ,, a) ( : ) b) / c) ( ) 51042,,,, 51043, ( ), 5105, 1 ISO/IEC ISO/IEC 65 2, : - / ,

32 5106 /,, 5107 /,,,, ( 547 ) 5108 (format) /, 1 /, 2 (headings) 5109 [ ], [ ],,, A ( ) A1-ISO/IEC ISO 9001:1994 ISO 9002:1994

33 ISO 9001 : 1994 ISO 9002 : 1994 ISO/IEC , a),f),h) a) 4101 and a), g), h) and i) and and , 422, , 422 and (na) 15, 542, 543, 544, 54, , 547, , 55, 561, 5621, , , 464, 47, , , , 53, 54, 55, 58, , 46, 552, , 559, 583, 584, , 59, , 55, , 541, 545, 55, , 58, and , 413(412) , , 521, na = ISO/IEC ISO 9001:1994 ISO 9002:1994 ( ) B1, /, B2 /,,,, / ( ), / B3, ( :,

34 ), /, /, /, / B4 /,,, /,, B5 ( : )

35 [1] ISO : - 1 : ISO , Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions [2] ISO : - 2 : ISO , Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method [3] ISO : - 3 : ISO , Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the precision of a standard measurement method [4] ISO : - 4 : ISO , Accuracy (trueness and precision) of measurement methods and results - Part 4: Basic methods for the determination of the trueness of a standard measurement method [5] ISO : - 6 : ISO , Accuracy (trueness and precision) of measurement methods and results - Part 6: Use in practice of accuracy values [6] ISO 8402 : 1994, -- ISO 8402, Quality management and quality assurance Vocabulary [7] ISO : 1994,, 1 : ISO :1994, Quality management and quality assurance standards - Part 1: Guidelines for selection and use [8] ISO :, 3 :,, ISO ISO :1997, Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply,

36 installation and maintenance of computer software [9] ISO : 1994,, 1 : ISO :1994, Quality management and quality system elements - Part 1: Guidelines [10] ISO : 1993,, 4 : ISO :1993, Quality management and quality system elements - Part 4: Guidelines for quality improvement [11] ISO ,, 1 : ISO , Guidelines for auditing quality systems - Part 1: Auditing [12] ISO ,, 2 : ISO , Guidelines for auditing quality systems - Part 2: Qualification criteria for quality system auditors [13] ISO ,, 2 : ISO , Guidelines for auditing quality systems - Part 3: Management of audit programmes [14] ISO ,, 1 : ISO , Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation for measuring equipment [15] ISO ,, 2 : ISO , Quality assurance requirements for measuring equipment - Part 1: Guidelines for control of measurement processes [16] ISO/IEC 17020, ISO/IEC 17020, General criteria for the operation of various types of bodies performing inspection [17] ISO Guide 30, ISO Guide 30, Terms and definitions used in connection with reference materials [18] ISO Guide 31, ISO Guide 31, Contents of certificates of reference materials [19] ISO Guide 32, ISO Guide 32, Calibration in analytical chemistry using certified reference materials [20] ISO Guide 33, ISO Guide 33, Uses of certified reference materials [21] ISO Guide 34, ISO Guide 34, Quality systems guideline for the production of reference materials [22] ISO Guide 35, -

37 ISO Guide 35, Certification of reference materials - General and statistical principles [23] ISO/IEC Guide 43-1, - 1 : ISO/IEC Guide 43-1, Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes [24] ISO/IEC Guide 43-2, - 2 : ISO/IEC Guide 43-2, Proficiency testing by interlaboratory comparisons - Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies [25] ISO/IEC Guide 58, - ISO/IEC Guide 58:1993, Calibration and testing laboratory accreditation systems - General requirements for operation and recognition [26] ISO/IEC Guide 65, ISO/IEC Guide 65, General requirements for bodies operating product certification systems [27], BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML Guide to the Expression of Uncertainty in Measurement, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML [28] ILAC Information and documents on laboratory accreditation can be found on the ILAC (International Laboratory Accreditation Cooperation): wwwilacorg

KOLAS-G KS Q ISO/IEC17025 /., KS Q , ( ). KS Q ISO/IEC VIM VIML ILAC-P10 ILAC KS P ISO KS P ISO KS Q IS

KOLAS-G KS Q ISO/IEC17025 /., KS Q , ( ). KS Q ISO/IEC VIM VIML ILAC-P10 ILAC KS P ISO KS P ISO KS Q IS 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,