This page outlines what you will receive when you purchase our Document Control Procedure (SYS-001).
Document control lists and forms are also included within this procedure. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:
- SYS-001 A, Document Control Procedure
- FRM-001 A, Document Change Notice
- LST-001 A, Master Document List
- LST-002 A, DCN List
The purpose of this Procedure is to ensure that documents within your quality management system are appropriately reviewed, approved and released and that documents are accessible to those who need to use them.
The scope of this procedure covers all of the documents that form part of your quality management system.
This procedure also applies to all Marketing Communications documents. This includes brochures, website content, flyers, etc..
Records are a particular type of document, excluded from this procedure but covered by SYS-002 Record & Data Control Procedure.
Customer documents that feed into the quality management system are a particular type of external document which is addressed in SYS-007 Customer-Related Processes Procedure.
This is the primary document meeting the applicable regulatory requirements for document control as defined in your Quality System Manual (POL-001).
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.
This procedure is to ensure that documents within your company’s quality management system are appropriately reviewed, approved and released, and that documents are accessible to those who need to use them.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below: