ISO 9001 document control 4.2.3

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Your mandatory document control procedure must define:

>    how you approve documents (eg procedures, flow-charts, process maps, etc.) prior to use e.g.signed-off paper versions, or added to your computer network via a password protected system.

>    how you update and re-approve amended documents computer based systems are so much easier to maintain.

>    how you identify changes e.g. by date or issue number, identify changes with different fonts or colours.

>    how you ensure that documents are available where they are needed

>    how you control documents of external origin

>    how you prevent the inadvertent use obsolete documents obsolete-but-still-in-use is the single most common non-compliance.

The standard tells us that documents are considered as information (e.g. specifications or procedures) and its supporting medium (e.g. paper or electronic). The standard implies that over time these documents will evolve as new information supersedes old and that change must be managed. Documents are active and dynamic.       

Remember; keep it simple and allow the process owners to write or revise the documents they need. Use the document management function to apply formatting and revision changes as well as looking after distribution and retention. It is best to interpret the requirements as they apply to your company; there is no hard and fast method.

Looking for help with your document control process?

We recommend the document management solution from ISO 9001 Checklist. It provides a great foundation for implementing a compliant document management system and includes everything you need to start controlling your documentation and records. It is simple, and easy to follow.

There are examples of the procedures and forms they provide here