Microbiology-PTM-OMA_Modules_1-5

Harmonization Studies:  ISO 16140 Acceptance Process

• Upon completion of MCS, a study  report is presented to MVTC  (electronic/twice a year in person)  or AFNOR TC (in person) • TC review report and  approve/reject data • If approved, ILS study protocol is  presented at the time of approval  to the TC.  • ILS protocol is approved and ILS  study is performed

• ILS data is added to MCS report  and presented to MVTC  (electronic/twice a year in person)  or AFNOR TC (in person) • TC approve or reject data  • If approved, method is granted  certification • Methods are reviewed every 4  years   • Changes to the ISO validation  guidelines or reference standards  may require additional validation  work