Understanding ISO 9001 document control requirements

Despite not being a regulatory requirement, the ISO 9001 standard is a popular framework for companies to improve their quality management systems. One of the components of the standard, ISO 9001 document control, ensures that companies record their ISO 9001 processes for internal communication and continuous improvement purposes.

What is ISO 9001 document control?

Documented information is a component of the ISO 9001 standard. It requires companies to have documentation of the processes they use to achieve adherence to the standard.

ISO 9001 document control ensures that companies have evidence of their conformity with the standard’s requirements. It also encourages transparency within organizations so that quality management efforts are traceable and actionable.

Tips for document control

The ISO intentionally does not outline specific requirements about the type of documentation you’re required to have on hand. That’s because quality management systems should be unique to the processes they cover.

That’s why it’s up to you how you want to meet the document control component. The first step is identifying all the processes that you’ll need to implement and maintain the ISO 9001 framework. This may include processes like quality assurance and production planning. Outlining this information first will make it easier to gather the documentation you need. Certain processes may have overlapping roles within your QMS, so try to consolidate details where you can.

You may consider using change management software to upload and manage documentation. This is especially true if you have a lot of processes to oversee and need a way to track any changes you make to them. Systems like Frontline MOC allow you to require approvals and signoffs so that nothing falls through the cracks while you’re making changes to documentation, processes, equipment, and more.

Frequently asked questions

Here are some of the most common questions about the ISO 9001 document control requirements.

What is the best way to implement a quality management system?

The ISO recommends starting by figuring out which processes you’ll need in place to do the implementation. Then you need to document all these processes in detail and make sure you have a method to track adherence to them. As you analyze the performance of your QMS processes, you can use that information to make improvements and ensure continuous alignment with ISO 9001.

What types of documents count towards the requirements?

There’s no specific type of document that you’re required to have for ISO 9001. It can be a paper document, digital file, magnet, flowchart, etc. It counts as long as it fulfills the information requirements of the standard.

If you already have a QMS in place, do you have to start from scratch with the documentation to implement ISO 9001?

No. If you already have a quality management system, you should go through existing documentation and adjust it so that it aligns with ISO 9001 instead. Check out our post on the role of top management in ISO 9001 implementation for more details.

What are some examples of documents that can help manage ISO 9001 requirements?

Some of the most common documents companies use to manage ISO 9001 compliance are quality plans, process flowcharts or maps, QA procedures, vendor requirements and logs, process instructions, and more.