ISO 9001 Document Control: Requirements and Best Practices

What is a controlled document under ISO 9001?

A controlled document can actually be a document, a spreadsheet, a drawing, work instruction, procedure, forms — really any form of official documentation. In relation to ISO 9001, a controlled document is any documented information that is important to your quality management system.

These documents are subject to formal review and approval, and controlled distribution and archiving or disposal. Each document version goes through defined document stages, such as draft or final approved, and is clearly labeled according to the stage it is in so that there is no confusion about which document is currently to be used.

Example: A controlled document may be a work instruction for equipment setup that includes revision history, approval signatures, document owner and expiration period.

ISO 9001 document control requirements

The amount and type of documents an organization needs to control depends on the industry, but the ultimate goal is to demonstrate the effective planning, operation and control of an organization’s processes.

Six core requirements of ISO 9001 document control

1. Maintaining documentation that supports work processes and ensures those processes are undertaken accordingly. Examples include SOPs, policies, training records and validation documents.

2. Establishing a method for creating and updating documented information that ensures the accuracy of the documented information. For example:

   1. Document identification and description (title, date, author or reference number)
   2. Format (language, software version, graphics)
   3. Media (paper or electronic)
   4. Document review and approval processes

3. Ensuring the availability of information under the following standards:

   1. Available and suitable for use where and when it is needed
   2. Adequately protected

4. Having a system for the control of documented information including:

   1. Distribution, access, retrieval and use
   2. Storage and preservation, including preservation of legibility
   3. Version control
   4. Retention and disposition

5. Determining and implementing the controls needed for documented information from external parties.

6. Establishing a system to prevent the unintended use of obsolete documented information. If it is retained, there must be a method to ensure that it is suitably identified to prevent its unintended use.

Document control isn’t just storage — it’s a system for protecting accuracy, traceability and compliance across your entire QMS.

Common ISO 9001 document control mistakes to avoid

Even organizations with established quality systems often struggle with document control. Understanding the most common pitfalls can help prevent audit findings, reduce risk and strengthen overall compliance.

1. Using uncontrolled spreadsheets or shared drives: Informal storage methods make it difficult to track versions, approvals, edits or user access, and they often lead to outdated documents being used on the floor.

2. Missing or incomplete revision history: ISO 9001 requires clear documentation of changes. Without a complete revision trail, auditors cannot verify what changed, when or who approved it.

3. Allowing access to outdated or obsolete documents: Old documents left in circulation are a major cause of nonconformances. Obsolete versions must be removed from use or clearly labeled as archived.

4. Lack of a defined approval workflow: Documents must be reviewed and approved before release. Without a standardized process, approvals can be delayed, inconsistent or undocumented.

5. Inconsistent retention and disposition practices: If documents are kept too long, disposed of improperly or retained inconsistently across departments, it signals poor control over documented information.

6. No central owner for document control: Without a person or role accountable for the process, documents can be mismanaged or updated without proper authorization.

7. Not controlling documents from external sources: External specifications, customer requirements or regulatory documents must be identified, tracked and kept current.

8. Slow or manual distribution of new revisions: If teams do not receive updated versions promptly, operations may continue using outdated instructions or specs.

Avoiding these mistakes makes it easier to implement a compliant, efficient document control process that supports consistent operations and audit readiness.

Step-by-step ISO 9001 document control process

Once you’ve familiarized yourself with the specific document control requirements outlined in ISO 9001, you’re ready to develop a document control policy that reflects your business and aligns with the ISO standards.

Step 1: Identify and classify your ISO 9001 documents

Clearly define document types, titles, revision levels, owners and formats. Typical categories include procedures, work instructions, forms and records.

Step 2: Build ISO-compliant review and approval workflows

Create procedures to ensure documents are reviewed and approved before use. QMS software can automate routing for electronic signatures and time-stamped approvals.

Step 3: Implement version control to prevent outdated use

Always retain control of previous versions to avoid accidental use. A centralized document management system should flag outdated versions and archive them automatically.

Step 4: Set access permissions and document distribution rules

Limit access to sensitive documents based on user roles or departments. Cloud-based QMS tools allow real-time access with customizable permissions.

Step 5: Establish retention and document disposal procedures

Establish retention schedules for each document type, and outline archival and obsoletion processes. Disposition should be tracked with logs or system-based audit trails.

For example, when updating a procedure, the system should automatically send the new version to the production supervisor for approval and archive the old version to prevent use.