IS O/ IE C 170 25 A S tu dy on th e Qu ality S y s t em b a s e d on IS O/ IE C 17025 200 1 2
IS O/ IE C 170 25 A S tu dy on th e Qu ality S y s t em b a s e d on IS O/ IE C 17025 200 1 2
200 1 2
.,. ISO( International Organization for Standardization ; ), ISO 9000,, 1999 10 ISO/ IEC 17025. ISO/ IEC 17025,., ISO 9001 ISO/ IEC 17025., K. - i -
A bs tract International tran saction is successfully accomplished on the basis of mutual r ecognition in the market. T he main v ehicle of mutual r ecognition is the conformity assessment of the other party. Special att ention m ay be applied to the testing and calibr ation labor atories as prerequisite for conformity assessment. In order to get rid of technical barrier s in the w orld trade, ISO( International Organization for Standardization ) made an important contribution to the international community by establishing ISO/ IEC 17025 Standar ds in October, 1999, which includes requir ement s of ISO 9001 Standar ds in the quality sy stem, the t echnical competence of testing and calibration laboratories, and v erification of their r esult s. In this study, thorough inv estigation w as m ade on the structur e and it s elem ent s of ISO/ IEC 17025, and as a result, som e suggestion s w er e m ade for the r equirem ent s in setting up of the quality sy stem of the testing and calibration labor atories. In addition, an att empt w as m ade to provide supplem ental and additional r equirem ent s for the testing and calibr ation labor atories which had been alr eady certified w ith ISO 9001 Standards. K testing and r esearch center w as chosen to study it s quality sy st em in the context of this r esearch, and suggestion s are m ade for the improv ement of it s quality sy stem to ov ercom e the problem in surv eillance. - ii -
... A b s tract... 1.... 1 1.1... 1 1.2... 3 2. IS O/ IE C 17025 ( )..4 2.1 IS O/ IE C 17025... 4 2.2 IS O/ IE C 17025... 4 2.1.1... 4 2.1.2... 7 3.... 10 3.1... 10 3.1.1... 11 3.1.2... 12 3.1.3... 16 3.2 IS O 900 1... 19 3.2.1 IS O 900 1 :2000... 20 3.2.2... 23 4.... 29 4.1 K... 29 4.2 K... 30 5.... 33 6.... 34
1. 1.1,,.,.,. WT O/ T BT (Conformity A ssessment ).[9] (ISO) (CASCO) 19. ISO,.,. APEC 94, EU.[24],,,.,.,.[11] ISO/ IEC.. - 1 -
EU 15 ( 1% )., /.[16]. ISO, IEC ISO/ IEC 17025. ISO/ IEC 17025 /. 3. ISO/ IEC 17025 EC. 1978, (KOLAS ;Korea Laboratory Accreditation Scheme), 1998 10 APLAC ISO/ IEC 17025.[2][22] ( KOLAS.),,.,, ISO/ IEC 17025. [24],.[24] ISO/ IEC 17025. - 2 -
1.2 ISO/ IEC 17025( ). ISO/ IEC 17025,.[20],, 3,.,,.[10], 2 ISO/ IEC 17025,,. 3,,, 3, ISO 9001 ISO/ IEC 17025 ISO 9001. 4 K,,. - 3 -
2. IS O/ IE C 17025 ( ) 2.1 IS O/ IE C 17025 [25] ISO/ IEC 17025. 2.2 IS O/ IE C 17025 2.1.1 (Sy stem Requirem ent s ). (1) / /,,.. - 4 -
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. ) -,. -. -. ) -,,,,. -. ). ( :,,,, ) ISO/ IEC 17025. 3.2 IS O 900 1.[10] ISO/ IEC 17025 KOLAS., ISO 9001 ISO/ IEC 17025 KOLAS,, ISO/ IEC 17025.[11] - 18 -
,,, ISO/ IEC 17025., ISO/ IEC 17025,.[18], ISO/ IEC 17025, ISO 9001,.. ISO/ IEC 17025,. ISO/ IEC 17025. - 19 -
3.2.1 IS O 900 1 :2000 ISO/ IEC 17025 ISO 9001 3-1. < 3-1> ISO 9001:2000 [4] ISO 9001:1994 ISO/ IEC 17025 1 1 2 2 3 3 4.1. 4.2.2 5.5.2 4.1.4 f), h) and 5.2.4 6.3 4.1.4 h), and 5.5.3 and 4.13.1 5.5.3 4.1.4 i) 5.6 4.14 4.1 4.2.1 to 4.2.3 4.2 5.1 ( ) 5.4.1 5.5.5 4.2.1 (in part ) and 4.12.1.1 and 5.4 5.4.2,, 7.1 7.2.2 4.4, 5.4.2 to 5.4.5 7.3, 5.5.6 4.3 and 5.4.8, - 20 -
ISO 9001:1994 ISO/ IEC 17025 7.4. 4.6 and 5.5.1, / / 4.5 7.4.2 4.6 7.5.3 5.8 7.5.2 5.8 7.1 7.5.1 7.5.5 5.1 to 5.3 and 5.9 ( :, ) 7.5.5 5.4 8.4 7.3.6 6.3 6.3 4.6 and 5.5.2 and 5.8.1 to 5.8.1.3 5.8.4 5.4.8 and 5.9 and 5.10.2.1 i) 4.12.2, 5.4 t o 5.6, 5.4.1 and 5.4.5.1 and 5.5.2, 5.5.2 and 5.6, 5.5.2 an d 5.5.6 an d 5.5.12, 5.5.9 5.5.4-21 -
ISO 9001:1994 ISO/ IEC 17025 5.5.6 and 5.5.7 8.3 6.3, 6.4 / 5.3 5.5.6 and 5.6.3.4 and 5.8 5.5.6 5.10.3.1 e) and 5.10.4.1 c) 8.3 4.9 8.5.2 4.10 8.5.3 4.11 5.8 5.5.7 4.12 8.2.2 4.13 6.2.2, 5.2.1 to 5.2.3 and 5.2.5 (in part ) and 5.5.3 8.1 5.9 ISO/ IEC 17025 ISO 9001., ISO/ IEC 17025 ISO 9001.[20] [21] ISO/ IEC 17025 ISO - 22 -
ISO 9001,,., ISO 9001 ISO/ IEC 17025. 3.2.2 ISO 9001 ISO/ IEC 17025. 4.1.4, /..[20].,.[10]. 3. ISO 9001. - 23 -
ISO 9001...[10],.., ISO/ IEC 17025.,.[2] ISO 9001,,,. - 24 -
,. ISO/ IEC 17025.[10] /,.,,..,.,. ISO/ IEC 17025,.,.[5][15] - 25 -
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ISO/ IEC 17025,.,.. ISO 9001 ISO/ IEC 17025.,. ISO/ IEC 17025 ISO 9001. - 28 -
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. 4. S/ W : 1... ISO/ IEC 17025( ),, 3.,,,.,. KOLAS.,, - 31 -
,.. KOLAS. - 32 -
5. ISO/ IEC 17025.. KOLAS ISO/ IEC 17025 ISO 9001 ISO 9001 ISO/ IEC 17025. ISO/ IEC 17025 ISO,. KOLAS, 2001, ISO/ IEC 17025.,,. ISO 9001 3.2,,,.. K, KOLAS.,. - 33 -
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[1], ISO/ IEC GUIDE 25,, 1997 [2],,, 1999 [3], ISO,, 1996 [4], ISO 9000,, 2000 [5], ISO 9000,, 1994 [6] ( ), http:// www.sytis.co.kr [7],,, 1996 [8] ( ), http:// www.lab911.com [9],,, 1999 [10] (2000), ISO/ IEC 17025, 3, pp. 35 39 [11], http:// www.kasto.or.kr [12], ISO 17025,, 1999 [13],,, 1994 [14], ISO 9000,, 1995 [15], ISO 9000,,1995 [16], http:// users.unitel.co.kr/ ~kotriceo [17],,, 1994 [18] Excel Partnership, INC., Calibration and T esting Laboratory Accreditation ISO/ IEC 17025 : How does it apply?, Excel Partnership,INC., 2000 [19] ISO/ CA SCO, ISO/ IEC 17020, 1999 [20] ISO/ CA SCO, ISO/ IEC 17025, 1999 [21] ISO/ T C, ISO/ DIS 9001:2000, 1999-35 -
[21] KOLAS,, KOLAS, 2000 [22] KOLAS, KOLAS NEWS LET T ER, KOLAS, 2000 [23] KOLAS, http:// kolas.ats.go.kr [24] MEAST ECH, http:// www.measinfo.com [25] Soh, I, ISO,, 1994-36 -