Transcription of QMSとGMP - e-nak.net
1 QMS GMP QC : GMP QMS ( QMS GMP ( ) ( ) FDA ISO9000 s EN46000 s(1993) 1994 GMP ( QA ) ISO9001+EN46001 1995 GMP QA ( 1997 GMP ( QSR) QMS (MIL-Q-9858A)AQAP(NATO ) GMP(FDA)ANSI Z ( ) / BS5750 GMP(FDA) GMP( ) GMP( ) ISO9000'sEN46000's( )))
2 ISO13485/13488 QA ( ) GMP QSR(FDA)1960's1970's1980's1990's2000'sIS O9000's/2000 ISO13485 2003 QMS