ISO/IEC 17025 1999-12-15
1 2 3 4 41 42 43 44, 45 / 46 47 48 49 / 410 411 412 413 414 5 51 52 53 54 / 55 56 57 58 / 59 / 510 A( ) ISO/IEC 17025 ISO 9001:1994 ISO 9002:1994 B( )
1 11 /, / 12 / 1, 2, 3/ ( ` ' ) /, / /,, 13 (note),, 14,, 15 16, / / / ISO 9001, ISO 9002 A ISO 9001 ISO 9002 ISO/IEC 17025 ISO 9001 ISO 9002 1 (ISO/IEC 58:1993, 413 ) B 2, ISO/IEC 58
2,, ISO IEC ISO 9001: 1994, -,,, ISO 9002: 1994, -, ISO/IEC Guide 2, VIM,, BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML 1, 2, ISO 9001 9002 2000 ISO 9001:2000 3, ISO/IEC Guide 2 VIM ISO/IEC Guide 2, /, ISO 8402 ISO 8402, ISO/IEC Guide 2 VIM
4 41 411 412, / 413 414 /, / 1 ( ),, 2 3,, 3 / 415 a), /, (52 ) b) /,, c),
d),, e),,, f) /,,, g) /,, / h) i), ( ) j) ( ), 42 421,, /,,,,,, 422 ( ) a) /
b) c) d) /, e) /, 423 424,, 43 431,,,,,,, / ( ) 1,,,,,,,,,,,,,, 2 / 547 412 432 4321 (master list),
4322 : a) b),, c), d) 4323 /,,, 433 4331, ( ) 4332, 4333,, 4334
44, 441, / : a),, (542 ) b) c) /, (542 ) 1,,,, 2,,, / /,, (trial test) 3 / 442,, ( : ),, /, 443 444 445,
45 / 451 ( :,, ) ( :, ),, 452, 453, 454 / 46 461 / /, 462 /, /, 463,,,,,,,, 464 /,,
47,, 1 : a) /, b) /,, 2,,, / 3, ( : ), /, 48 (410 ) 49 / 491 / : a) (,, ) b) c) d),
e) /,,,,,, 492,,, 410 410 4101,,,,, 4102,,,,, 4103,, 4104
4105,, 413, 411 4111,,, 4112 1 2,, 412 4121 41211,,,,,, 41212, 41213
41214 (back-up) 4122 41221, (audit trail),,, /,,, /, 1 2 /, (parameters) (547 ),,,,,,,,, 41222, 41223,,, 413 4131, /, 4132, / ( ),,,
4133, 4134 414 4141,, / : - - - - - - - - - -, 1 12 2 /,,, 3 4142 5 51 511 / :
- (52) - (53) - / (54) - (55) - (56) - (57) - / (58) 512 ( ) ( ) /,, 52 521, /,,,,, / 1 ( : ), 2,, -,,, - -,, 522,, 523 ( ), ( )
524 /, (/ ), - / - /, - -, - - - 525, /,,,,,,,, / 53 531,, /, / / 532,,,,,,,,,,,, /, / 533, (cross-contamination) 534 / 535
54 / 541 / /,,,,, / /,, /,,, (43 ) /,, /,, 542, /, /,,,,,, /, 543
/ 544, / /, /, : (a) (b) (c) / (d) (e) (f), (g) (h) -,,,, -, -,,, -, - (i) / / (j), (k) 545 5451 5452, /,,
1, 2, - - - - - 3,,, 5453 ( :,,,, /, (robustness) / / (matrix) (cross-sensitivity)) 1,, 2, 3, ( :,,,,,, ) 546 5461 5462,,,,, 1 - -
- (narrow) 2, (510 ) 5463, 1,,,,, / 2, / 3 ISO 5725 ( ) 547 5471 5472 /,,,,, : a) b) (integrity),, c), / ( :,, ) / 5472a
55 551 / (, /, / ),, 552,, /, ( ) /, / (56 ) 553 ( ) 554, / 555 / : a) b),, c) (552 ) d), e), f),,,, g), h),, (modification)
556, (deterioration),,,, 557,,,, / /, (49 ) 558,, 559,, 5510, 5511, ( : ) 5512 / /
56 561 ( : ),, /,, /,,,, 562 5621 56211, (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,
5, SI 1 6 7, (BIPM) 8 56212 SI, - (CRM) - / 5622 56221, 5621, 5621, 56222 SI /,,, / (56212 ) 563
5631 5621, 5632, SI 5633, 1, 5634,,,,, 57 571 / (substance),, / 1 /,, ( : ), 2,,
, 572,,, /, 573 /,, ( ),, 58 / 581 /, /,,,,, / 582 /, 583 /, / /,, /, / 584,,,,,, 1,, /
2 3 /, / 59 / /,,, a) / 2 b) c) / d) e) 510 5101, /,,,, / ( 1 ),, / 5102, 5103 5104
/, 5102, 5103 5104 / 1 2, 5102, : a) ( : ` ' ` ') b), / c) ( : ),, d) e) f) /, g), / h), i) / j),, k), /
1 2 5103 51031 5102,, : a), b), / / c), :,,, d), (5105 ) e), 51032 5102 51031, : a) b), (,, ) c),, d) e) f), 5104
51041 5102,, a) ( : ) b) / c) (56211 2 ) 51042,,,, 51043, 51044 ( ), 5105, 1 ISO/IEC 17020 ISO/IEC 65 2, : - / - - - 3,
5106 /,, 5107 /,,,, ( 547 ) 5108 (format) /, 1 /, 2 (headings) 5109 [ ], [ ],,, A ( ) A1-ISO/IEC 17025 ISO 9001:1994 ISO 9002:1994
ISO 9001 : 1994 ISO 9002 : 1994 ISO/IEC 17025 1 1 1 2 2 2 3 3 3 411 411 413, 422 4121 4121 415 a),f),h) 424 491a) 4101 and 525 4122 4122 415 a), g), h) and 551 4123 4123 415 i) 413 413 414 421 and 422 421 and 422 421, 422, 423 423 423 421, 422 and 414 43 43 44 44 44(na) 15, 542, 543, 544, 54,5 45 45 43, 547, 5511 461 461 46, 55, 561, 5621, 5622 462 462 45, 46 463 463 46 464 464 45, 464, 47, 552 47 47 58, 5106 48 48 554, 58 49 49 412, 53, 54, 55, 58, 59 4101 4101 54 4102 4102 45, 46, 552, 58 4103 4103 49, 559, 583, 584, 59 4104 4104 547, 59, 5101 4105 4105 4122 4111 4111 54, 55, 57 4112 4112 53, 541, 545, 55, 56 412 412 5512, 58, 592 413 413 49 414 4141 410 and 411 415 415 59 416 416 412 417 417 4105, 413(412) 418 418 52, 553 419 419 47, 521, 5105 420 420 59 na = ISO/IEC 17025 ISO 9001:1994 ISO 9002:1994 ( ) B1, /, B2 /,,,, / ( ), / B3, ( :,
), /, /, /, / B4 /,,, /,, B5 ( : )
[1] ISO 5725-1 : - 1 : ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions [2] ISO 5725-2 : - 2 : ISO 5725-2, 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 5725-3 : - 3 : ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the precision of a standard measurement method [4] ISO 5725-4 : - 4 : ISO 5725-4, 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 5725-6 : - 6 : ISO 5725-6, 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 9000-1: 1994,, 1 : ISO 9000-1:1994, Quality management and quality assurance standards - Part 1: Guidelines for selection and use [8] ISO 9000-3:, 3 :,, ISO 9000-1 ISO 9000-3:1997, Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply,
installation and maintenance of computer software [9] ISO 9004-1: 1994,, 1 : ISO 9004-1:1994, Quality management and quality system elements - Part 1: Guidelines [10] ISO 9004-4: 1993,, 4 : ISO 9004-4:1993, Quality management and quality system elements - Part 4: Guidelines for quality improvement [11] ISO 10011-1,, 1 : ISO 10011-1, Guidelines for auditing quality systems - Part 1: Auditing [12] ISO 10011-2,, 2 : ISO 10011-2, Guidelines for auditing quality systems - Part 2: Qualification criteria for quality system auditors [13] ISO 10011-3,, 2 : ISO 10011-3, Guidelines for auditing quality systems - Part 3: Management of audit programmes [14] ISO 10012-1,, 1 : ISO 10012-1, Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation for measuring equipment [15] ISO 10012-2,, 2 : ISO 10012-2, 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, -
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