1. (Taiwan Accreditation Foundation ) (ILAC, International Laboratory Accreditation Cooperation) (APLAC, Asia Pacific Laboratory Accreditation) (Mutua

能力試驗要求 draft7 實驗室認證規範

1. (Taiwan Accreditation Foundation ) (ILAC, International Laboratory Accreditation Cooperation) (APLAC, Asia Pacific Laboratory Accreditation) (Mutual Recognition Arrangement) 2. / / / / ( ) 4.1 4.2 APLAC : (1) ISO/IEC 17011 2004 (General requirements for bodies providing assessment and accreditation of conformity assessment bodies) 7.15 (2) APLAC MR001:2006 Procedures for Establishing and Maintaining Mutual Recognition Arrangements amongst Accreditation Bodies 3.3 (3) ILAC P9 2005 ILAC Policy for Participation in National and International Proficiency Testing Activities 3. 3.1 ( ) 3.2 3.3 ( measurement audit) 3.4 2007.01.03 draft7 1 22

( APLAC) / (a) 参 ( ) (b) (c) (d) 4. 4.1. 4.1.1 ( ) 4.1.2 ( ) 4.1.3 4.1.1 4.2 APLAC 4.2.1 APLAC / 4.2.2 4.2.1 2007.01.03 draft7 2 22

APLAC APLAC APLAC APLAC 4.3 / / :1. 2. ( ) ( : ) 3. 4. (a) (b) 4.4 4.4.1 / / ( ) 4.4.2 2007.01.03 draft7 3 22

/ ISO 13528 4.5 4.5.1 / / / / 4.5.2 4.5.1 ( ) ( ) 4.5.3 / (, ) ( ) 30 5. 5.1 4 5.2 2007.01.03 draft7 4 22

: - 2 1 1.Collaborative Testing Services Inc. www. collaborativetesting.com 2. ASTM(www.astm.org) 3.Proficiency Testing, Australia - 2 1 1. 2.Collaborative Testing Services Inc. www. collaborativetesting.com 3. ASTM(www.astm.org) 4.Proficiency Testing, Australia - 2 1 Proficiency Testing, Australia 1.Interlab Division Vanguard Solutions 3 1 www.roundrobins.com 2.Proficiency Testing, Australia 3.Mineral Analysis Laboratory, Canada www.nrcan.gc.ca - 1.Group Leader CMRL 3 www.ccrl.us 1 2.Cement and Concrete Association of Australia 2007.01.03 draft7 5 22

- 1.ASTM(www.astm.org) 1 2. Proficiency Testing, Australia /1 3. Institute for Interlaboratory Studies www.iisnl.com - 2 1 1. 2. Collaborative Testing Services Inc. www. collaborativetesting.com 3. ASTM(www.astm.org) 4. Institute for Interlaboratory Studies www.iisnl.com 1.Proficiency Testing, Australia 2. ASTM(www.astm.org) 3 1 3.Institute for Interlaboratory Studies www.iisnl.com 1. 1 1 2. 3.Interwinery Analysis Group, Australia www.interwinery.com 4.AgriQuality Services, Australia Proficiency 5.AOAC International - 3 1 1.National Residue Survey, Australia http://www.daff.gov.au/nrs 2007.01.03 draft7 6 22

1. 2. 1 1 3.FAPAS 4.American Industrial Hygiene Association / 1. 2. 1 1 3.FAPAS - 1. 2.Canadian Association for 1 1 Environmental Analytical Laboratory(C.A.E.A.L) 4.Environmental Resource Associates, Inc. ERA 3. - 1 1 1 1-1 1-1 1 2007.01.03 draft7 7 22

1. 2.College of American 1 1 Pathologists (CAP) 3 1-3 1 EMC 3 1 EMI 3 1 2007.01.03 draft7 8 22

: 2007.01.03 draft7 9 22

: HA HA HB HB0101 (Glucose-Blood) HB HB0203 (Alanine aminotransferase; ALT) HB0204 HB (Asparatate acid aminotransferase; AST) HB0301 (Triglyceride) HB0302 (Cholesterol) HB0307 (Creatinine) -- ( ) HB0308 (Uric acid)-- ( ) HB0310 Blood urea nitrogen; BUN HB0605 (β-hcg) HC HC 2007.01.03 draft7 10 22

HD HD0101 (RBC HD Count) HD0102 (Hemoglobin; Hb) HD0103 (Hematocrit; Hct) HD HD0201 (WBC Count) HD0202 (WBC Differential Count) HD0301 (Platelet Count) HE -RPR/VDRL(RPR/VDRL test) HE HE0602 / (TPHA/TPPA test) HF0408 B HE (Hepatitis B virus surface antigen, HBs Ag) HF0423 (HIV antibody Screening) HF HF HF05 HG HG 2007.01.03 draft7 11 22

HH HH02 (Urine HH strip) HH0318 (Urine of pregnancy test) HH0309 HHE ( Urine sediments) HH0408 (Fecal occult blood) HI HI HJ HJ DNA (CDC) Bio-Rad company NATA RCPA proficiency testing program Newborn. Screening Quality Assurance Program College of American Pathologists RCPA Quality Assurance Programs 2007.01.03 draft7 12 22

: 1 KA KA10 (Gauge Block) KA20 (Caliper) (Outside Micrometer) KC KC10 (Weight) KC40 (Torque Wrench) KD KD10 (Pressure Gauge) Bureau of Laboratory Accreditation, Department of Science Service, Ministry of Science and Technology, Tailand KE KE10 (Resistance Thermometer) NIST Office of Weights and (Thermocouple) KF Measures, U.S.A KF10 (DC Voltage) (DC Current) (AC Voltage) (AC Current) HN Proficiency Testing Inc., KF30 (Resistance) U.S.A. Quametec Proficiency Testing Services, U.S.A. National Association for Proficiency Testing (NAPT), U.S.A 2007.01.03 draft7 13 22

KJ (Quartz) Quametec Proficiency Testing Services, U.S.A. KK KK10 (Gamma Radiation Dosemeter and Doseratemeter) KK20 (Solid Source/Alpha Emission Rate) (Solid Source/Beta Emission Rate) 2 1 KA Length KA1001 Gauge Block KA1003 Ring Gauge KA1004 Step Gauge KA1009 Caliper Checker KA1011 Step Height Specimen KA1012 Electronic Distance Meter KA1017 Wire Gauge KA1019 Dial Gauge Calibrator KA1020 Laser Interferometer KA1021 Grobal Positioning System Receiver 2007.01.03 draft7 14 22

KA2001 Standard Rule KA2002 Standard Tape KA2003 Caliper KA2005 Outside Micrometer KA2010 Dial Indicator KA2013 Levelling Staff KA2014 Pitch Standard KA3001 Angle Gauge Block KA3002 Square KA3003 True Square KA3004 Precision Index KA3005 Polygon KA3007 Theodolite KA3014 Square KA3015 Spirit Level KA3016 Electronic Level KA3018 Optical plummet KA4001 Roughness KA4002 Surface Plate KA4004 Roundness KA4007 Profile Projector KA4009 Film Thickness Standard KB Vibration & Acoustics KB1001 Accelerometer KB1002 Vibration Meter KB2001 Microphone KB2002 Pistonphone KB2003 Sound Level Calibrator KB2004 Sound Level Meter 2007.01.03 draft7 15 22

KC Mass/Force KC1001 Weight KC2002 Load Cell KC2004 Force Gauge KD Pressure/Vacuum KD1004 Pressure Gauge KD1005 Pressure Transducer KD2001 Spinning Rotor Viscosity Vacuum Gauge KD2002 Ionization Vacuum Gauge KD2003 Capacitance Diaphragm Vacuum Gauge KD Pressure/Vacuum KD1004 Pressure Gauge KD1005 Pressure Transducer KD2001 Spinning Rotor Viscosity Vacuum Gauge KD2002 Ionization Vacuum Gauge KD2003 Capacitance Diaphragm Vacuum Gauge KE Temperature/Humidity KE1001 Liquid-in-glass Thermometer KE1002 Platinum Resistance Thermometer KE1004 Thermocouple KE1007 Radiation Thermometer 2007.01.03 draft7 16 22

KE2001 Hygrometer KE2002 Moisture Meter KF Electricity KF1001 DC Voltage KF1002 DC Current KF1003 DC High Voltage KF1004 DC High Current KF1011 AC Voltage KF1012 AC Current KF2001 A.C. Electrical Power KF2002 A.C. Electrical Energy KF2003 Phase Angle KF2006 AC Power Primary KF3001 Resistance KF3002 Inductance KF3003 Capacitance KG Electromagnetics KG1001 Microwave Power KG3008 Spectral Responsivities of Photometric Detector KH Flow KH1001 Air/Flow Rate KH1002 Water/Flow Rate KH2001 Air/Quantity KH2002 Water/Quantity 2007.01.03 draft7 17 22

KI Chemical KI1000 KI4000 KI7000 KJ / Time/Frequency KJ20 KK Chemical KK10 KK20 2007.01.03 draft7 18 22

/ : : : (1) ISO/IEC Guide 43 ILAC G13( 1) (2) ( 2) (3) PT Provider Proficiency Testing Provider PT (4) PT Provider 1: 2: PT Provider ISO/IEC Guide 43 / ILAC G13 1. PT Provider (instructions) : PT 2.. PT Provider PT : 3 PT Provider PT 3.1 PT 3.2 / 3.3 / 2007.01.03 draft7 19 22

3.4 3.5 / 3.6 / 3.7 (assigned value) (acceptable range) : 3.8 3.9 / 3.10 3.11 3.12 4 PT 2007.01.03 draft7 20 22

5 PT / 6 : ( / / ) ( ) ( ): : : 2007.01.03 draft7 21 22

PT Provider( ) [ ] [ / ] ( / / ) ( ) ( ): : / / ( ) 2007.01.03 draft7, 22 22 :300 30