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Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project… your strategy requires QMS oversight.

QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.


The importance of identifying and updating all the documents that contain references to obsolete versions or documents

Both the ISO 9001 and ISO 13485 standards have requirements regarding proper document control and maintenance. These include all issues related to obsolete documents:

  • if a document becomes obsolete along with all its versions.
  • if only certain versions (mostly the previous ones) become obsolete.

Managing documents of a complex project is always challenging, but in every firm documented procedures should describe the Company’s strategy on how to manage the issue of obsolete documents, where and how to store these documents, and what is the retention period, etc.
ISO 9001 specifies the retention period to be at least the lifetime of the medical device or the other marketed product, this is to prevent the unintended use of these documents and to identify and update all the documents that contain references to obsolete versions or documents.    

Although document owners are responsible for their own documents (that includes: proper document follow-up and updates, as well as administering the relationships between documents), policies for handling obsolete documents, and the strategy to monitor and update the references to different document versions are important to follow.  These can prevent applying obsolete information that could cause unexpected and unforeseeable problems in the future.

Every company should have a specific data table that is intended to manage document references, or consider implementing an automated search engine for discovering such references inside certain documents. 

Cup of Joe: References on Obsolete QMS Documents

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