This is a collection of Provision, Procedure, and Forms for design changes in a form consistent with the FDA QSR.
Design changes must be implemented in accordance with strict procedure.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K4i Design Change Provision
・MD-QMS-S405 Design Change Procedure
・MD-QMS-F430 Design Change/4M Change Request
・MD-QMS-F431 Application for change
・MD-QMS-F432 Design Changes/4M Changes Form
・MD-QMS-F433 Dectermination of propriety of change

Table of Contents

Provision

1 Purpose
2 Scope
3 Definitions
4 Design Changes/4M Changes
5 Criteria for request of Corrective action / Preventive action
6 References
7 Supplementary provision

Procedure

1 Purpose
2 Scope
3 Definitions
4 Roles and Responsibilities
5 Implementation procedure
5.1 Change request
5.2 Implementation of change
5.2.1 Preparation for change
5.2.2 Design transfer
5.3 Records keeping
6 Forms
7 References
8 Supplementary provision