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: