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. The procedure can be used with both virtual quality systems or an eQMS. You could even modify this procedure for working with a Wiki to control documents.
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.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below:
About the Author
Rob has 20+ years of experience in the medical device industry and another 10 years of experience in biotech manufacturing validation and scale-up. He is a UConn graduate in Chemical Engineering. He was Director of Quality and Regulatory Affairs at four different medical device start-ups, and in 2004 he was co-founder and President/CEO of a laparoscopic imaging company. His quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for BSI–one of the largest Notified Bodies in Europe. Today Rob is co-founder and President of Medical Device Academy, a full-service quality and regulatory consulting firm that specializes in helping start-up medtech companies get their first device or IVD product to market. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.