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: