The Starter Pack

Starter Pack Contents

  • Document Control System (SOP + MDL + headers/footers + doc coding system)

  • Change Control Log (register + form)

  • ISO 14971 Basic Risk Kit (hazard list + matrix + residual risk form + RMP + RMF shell)

  • Training & Competence Kit (competency matrix, training record template, evaluation forms)

  • Supplier Starter Tools (supplier registration form, basic ASL, starter supplier evaluation sheet)