managing controlled documents under iso 9001

Industry standards like ISO 9001 have strict document control requirements to achieve compliance.

If your business needs to meet this standard, you must have an effective management system for these controlled documents.

In this article, we look at what controlled documents are and the best way to ensure your system meets the necessary requirements:

What are controlled documents?

A controlled document is any digital or hardcopy document that’s required by a standards organization or a regulatory authority to be closely managed to ensure that the documents are accurate and complete through all processes and revisions.

A controlled document management system is used to ensure all edits, reviews, approvals, revisions, and distribution meets required standards and everyone working on the document is working with the correct version.

Examples of controlled documents include engineering drawings, industrial diagrams, operating procedures, contracts, and plans.

ISO 9001 requirements for managing controlled documents

ISO 9001 requires organizations to establish a system to manage controlled documents. This system is part of the organization’s overall quality management system (QMS).

For example, a manufacturer that must ensure the quality of a product under ISO 9001 will have a QMS that includes procedures that dictate quality assurances. Controlled documents make up part of this procedure and must coincide with the QMS.

According to ISO 9001:2015:

“Documented information required by the quality management system and by this International Standard shall be controlled to ensure:

  • it is available and suitable for use, where and when it is needed;
  • it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).”

Older versions of ISO 9001 were specific about what documents were required. The latest version is more flexible to allow for modern file types. Controlled documents can be hardcopies or digital documents, including videos and audio files.

Why document control is vital

Document control is a requirement for ISO 9001 compliance, but it’s also good practice for any business with a quality management system.

A document control system ensures that documents related to quality management are accurate and that everyone in the organization is working with the correct version. This is especially important when documents undergo frequent changes and approval processes.

A QMS with a document control system helps ensure that even the most complex documentation is standardized across the organization and meets all requirements for compliance.

Document control vs. document management: what’s the difference?

While very similar, document control and document management aren’t the same. Both are systems of records management, but document control is a much narrower field that requires more accuracy and version control.

General document management is used in most organizations, but controlled documents – those specific to compliance with QMS and ISO standards – need a document control system.

It would be fair to say document control is a form of document management, but document management doesn’t fall under the umbrella of document control.

How to simplify management of controlled documents

Every organization will have its own approach to setting up a management system for controlled documents. It’s important that this system fits into the overall quality management system to ensure ISO 9001 compliance.

Setting up a document control system

Having a designated document controller is a good start when it comes to simplifying your management system. This person should be experienced in document management and quality management systems as they relate to ISO 9001.

A document control system usually, but not always, follows these basic steps:

Step 1: Identify the necessary documents for compliance and which workflows they belong to. The entire lifecycle of each document from creation to archiving must be outlined.

Step 2: Establish who is responsible for each document. Identify who has the authority to approve and release each document.

Step 3: Establish quality standards for each document. For example, do they require legal review for compliance?

Step 4: Give each document a name and classification. Consistent naming conventions are vital for document identification and retrieval.

Step 5: Create revision guidelines so staff know how to implement changes and how to document these revisions, including who is responsible for approval.

Step 6: Manage access. Security is vital for document control and can be a compliance requirement. Establish who has access and editing capabilities for each document.

Step 7: Establish version control and archiving protocols. This prevents the existence of superfluous and confusing users. Obsolete documents should be archived or destroyed.

Using document control software

Document control software allows you to create a document control system like the one above that is centralized and easy to access by relevant users wherever they are.

A cloud-based software system is also always up to date and includes automation that simplifies basic processes within the document control system.

isoTracker’s document control software is subscription based, so you can create an affordable online system that’s secure and accurate, making it much easier to achieve ISO 9001 compliance.

Get a 60-day free trial with full access to the isoTracker quality management system including our document management module.