QMS (Distributors) Audit Requirements Package

The Audit package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The Audit package contains the Audit Procedure, and 4 related Templates. The package is compliant with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/46. (number of documents – 5)

  • SOP 5.0 Auditing Procedure
  • T 5.0-1 Audit Plan Template
  • T 5.0-2 Audit Notes List Template
  • T 5.0-3 Audit Report Template
  • T 5.0-4 Audit Programme 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