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
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