QMS (Distributors) Traceability Requirements Package

The Traceability package, as a part of Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Traceability package contains the  Traceability Procedure, and 2 related Templates. The package is complied with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/46. (number of documents – 3)

  • SOP 4.2 Traceability Procedure
  • T 4.2-1 Traceability (incoming) register Template
  • T 4.2-2 Traceability (shipped) register Template

Please note that once purchased, the product cannot be returned or refunded.

Big Bundle Packages as well available:

Quality Management System (QMS) (Distributors) Bundle

Quality Management System (QMS) (Distributors) Bundle + Additional Services