QMS (Distributors) CAPA Package

The CAPA package, as a part of the Quality Management System (QMS), has been developed for distributors of Medical or In Vitro Diagnostic (IVD) devices. The CAPA package contains the CAPA Procedure, and 3 related Templates. The package is compliant with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/46. (number of documents – 4)

  • SOP 5.4 Corrective and Preventive Action (CAPA) Procedure
  • T 5.4-1 CAPA Form Template
  • T 5.4-2 CAPA Extension Form Template
  • T 5.4-3 CAPA List 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