よりよい検査室管理をめざして - jaclap.org

1 Lab Clin Pract. 26(2) 62-67(2008) 62 ( ) 1)

2 (globalization) (World Health Organization: WHO) 1990 (International Organization for Standardization: ISO) 1 (ISO) (International Electro-technical Commission: IEC) ISO (International Telecommunication Union: ITU) 3 ISO ISO a ISO/TC212, Clinical laboratory testing and in vitro diagnostic test systems[ ] 1995 ( American National Standards Institute: ANSI) Clinical and Laboratory Standards Institute(CLSI NCCLS) Donald Powers(USA) 33 P (Japan Industrial Standards Committee: JISC) 63 JCCLS 3 (Working Group.)

3 WG) 4 WG4 4 WG WG1 Quality and competence in the clinical labo-ratory[ (Convenor: James Jones(UK) ) WG2 Reference systems[ ] (Con-venor: Rene Dybkaer(Denmark ) WG3 In vitro diagnostic products[ ](Convenor: Kay Setzer(USA) ) WG4 Antimicrobial susceptibility testing[ ](Convenor: James Jorgenson(USA) ( ) ) WG (International Standards: IS) (Technical Specification: TS) ISO (voluntary stan-dards) (World Trade Or-ganization.)]

4 WTO) IS IS EN( European Standards) EN 2 ISO ( ) clinical laboratory( medical laboratory ) ( )

5 ISO/ TC212 (Technical Committee: TC) (Scope) TC ISO/TC212 Lab Clin Pract. (2008) 64 3 ISO 15189 ISO/TC212 1995 2008 14 ( ) ISO 15189 Medical labora-tories Particular requirements for quality and com-petence[ ] 2003 2 2007 1 IS (accreditation bodies) 4 5 2) 4) a 4 ISO 9001:2000, Quality man-agement system Requirements[JIS Q 9001.]

6 2000 ] PDCA(Plan Do Check Act) 1 ISO 15189:2007 1) 1 (Scope) 2 (Normative references) 3 (Terms and definitions) 4 (Management requirements) 4 1 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 4 10 4 11 4 12 4 13 4 14 4 15 5 (Technical requirements) 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 A( )ISO 9001:2000 ISO/IEC 17025:2005 B( ) (LIS) C( ) 65 ISO 9001:2000 ( ) ( ) b 5 ISO/IEC 17025, 2005, General requirements for the competence of testing and calibration laboratories[JIS Q 17025.

7 2005, ] ( ) ( ) 3) ISO 9001 ISO/IEC 17025 ISO 15189 4 ISO 15189 ISO 15189 ( ) ( ) ISO 15189 ISO/CASCO(Conformity Assessment Committee )

8 / ISO 9001 (certification) ISO/IEC 17025 ISO 15189 (accreditation) 1 1 ISO 15189 IS a ISO 15189:2003 (JCCLS) ( ) (JAB) (ISO 15189 ) 2005 2008 10 41 ( ) ( ) 4 2 Lab Clin Pract.

9 (2008) 66 ( ) ( ) 1 ( 5 1 ) 1 b CLIA 88( 1988 ) (CAP ) 2008 CAP CAP/LAP(Laboratory Accreditation Program) ISO 15189 ( ) ISO/IEC 17025 2005 ISO 15189 CAP/LAP ISO/IEC 17025 2003 ISO/EN 15189 ISO 15189 ( ) 5 ILAC(International Laboratory Accreditation Cooperation ) (Mutual Recognition Arrangement.)

10 MRA) 4 APLAC(Asia-Pacific Laboratory Accredita-tion Cooperation ) ILAC MRA ILAC/MRA one stop testing ( ) (JAB) ILAC APLAC MRA 6 a ISO ( ) (documentation) 1956 1962 Anatomic Pathology/Clinical Pathology (Standard Oper-ating Procedure.