When you purchase our Change Control Procedure (SYS-006) you will receive the following items from this outline.
Checklist forms and list templates are included with the procedure. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:
- SYS-006 A, Change Control Procedure
- FRM-002 A, Training Record
- FRM-012 A, Change Note
- FRM-019 A, Design Requirements Trace Matrix
- LST-009 A, Change Register
Purpose
The purpose of this procedure is to ensure that changes to any product or process within the scope of your company’s quality management system are planned, approved and implemented in a controlled manner, maintaining the safety and efficacy of product and the effectiveness of the quality management system.
Scope
This procedure applies to any changes to product that has been released for manufacture and to any changes to process that will result in a change to product or process documentation or that otherwise may potentially have an impact on product characteristics or safety.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
SYS-006 Change Control Procedure/Forms
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