QMS (Distributors) Nonconforming Product Requirements Package

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

  • SOP 5.2 Control of Nonconforming Product Procedure
  • T 5.2-1 Product Nonconformity Report Template
  • T 5.2-2 Product NCR Register Form 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