Our ISO 15189 Deliverables

  • QMS Manual, quality policy & objectives
  • Required SOPs, work instructions, forms and logs (controlled documents)
  • Risk register & improvement log
  • Method validation/verification and measurement uncertainty reports
  • Internal audit program, plans, checklists & reports
  • Management review agenda, minutes & action trackers
  • EQA/PT participation plan & performance review templates
  • Equipment calibration/verification plans and traceability records
  • CAPA system with root-cause tools and effectiveness verification