Your Comprehensive Guide to ISO 9001 Document Control

January 26, 2024

If you are working on ISO 9001 related projects and unsure of the best way to manage document control, you might be looking in the wrong places.

While spreadsheets and document folders can help to a certain extent, managing ISO 9001 document control day-to-day is much easier, efficient and reliable when you automate your quality management system (QMS) with software. Here we explore the key ISO 9001 document control standards and some of the most efficient ways to meet them.

What is ISO 9001 document control?

ISO 9001 document control involves the entire process of organizing documentation to meet the requirements set forth by ISO 9001, an international quality standard that requires businesses to have a “controlled,” or organized, set of documents that reflect the details of how they are managing quality.

ISO standards are internationally agreed upon by experts. Think of them as a formula that describes the best way of doing something. It could be making a product, managing a process, delivering a service or supplying materials – standards cover a huge range of activities.

Companies that are certified as meeting the ISO 9001 standard demonstrate consistent quality and reliability to potential customers. In fact, many corporations require this certification from their suppliers.

What is a controlled document 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.

ISO 9001 document control core requirements

Document control is a major component of a sound quality management system. The amount and type of documents controlled depends on the industry, but the ultimate goal is to demonstrate the effective planning, operation and control of an organization’s processes.

Primary ISO 9001 document control needs:

Maintaining documentation that supports work processes and ensures those processes are undertaken accordingly. Examples include SOPs, policies, training records, and validation documents.
Establishing a method for creating and updating documented information that ensures the accuracy of the documented information. For example:
- Document identification and description (e.g., a title, date, author or reference number)
- Format (e.g., language, software version, graphics)
- Media (e.g., paper or electronic)
- Document review and approval processes
Ensuring the availability of information under the following standards:
- Available and suitable for use where and when it is needed
- Adequately protected
Having a system for the control of documented information including:
- Distribution, access, retrieval and use
- Storage and preservation, including preservation of legibility
- Version control
- Retention and disposition
Determining and implementing the controls needed for documented information from external parties.
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.

How to control documents ISO 9001

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.

Develop a Document Control Policy: This policy should define roles and responsibilities, the document lifecycle, and the procedures for creating, reviewing, approving and updating documents.
Systematize Document Identification: Implement a system for uniquely identifying each document, typically a naming convention, number or code that clearly indicates the document's purpose and content.
Ensure Version Control: Develop robust version control mechanisms that help prevent the use of outdated documents and can track changes over time.
Define Access Controls: Set up access controls to restrict document access to authorized personnel only. This includes defining who can view, edit, approve and distribute documents within the organization.
Design Review and Approval Workflows: Design a workflow for document creation, review and approval. This ensures that documents undergo a systematic review process before being finalized and implemented.
Manage Document Changes: Establish a change management process for document updates. Changes should be documented, and relevant stakeholders should be notified of modifications to ensure everyone is working with the latest information.
Create Audit Trails: Implement an audit trail feature that logs all interactions with documents. This is crucial for maintaining transparency and accountability, especially during audits.
Training and Awareness: Provide training to employees on how and when to use the document control system. Ensure that they are aware of the importance of following document control procedures to maintain ISO 9001 compliance.
Integrate with Other Systems: Integrate your document control system with other quality management systems and tools to streamline processes and ensure consistency across the organization.
Conduct Regular Audits: Conduct regular internal audits of your document control system to identify areas for improvement and ensure ongoing compliance with ISO 9001 standards.

Is ISO 9001 document control software for you?

ISO 9001 document control guidelines do not specify the method of document management you must use. But manual document control can be cumbersome, time consuming and more open to human error, which can ultimately negatively affect your bottom line.

ISO 9001 document control software improves efficiency by centralizing document management processes into one electronic resource that provides access control and version control, facilitates electronic approvals, simplifies distribution and offers additional features, such as electronic reminders.

A good ISO 9001 document control software should enable you to do these four critical things:

Centralize and control document access, distribution and retrieval
Automatically manage and record document changes
Provide electronic document distribution and approval
Maintain a system of document archiving and/or disposition

What features should you look for in ISO 9001 document control software?

When comparing document management solutions, look for features that fit your workflows the best, are easy to use and efficient. Modern, electronic systems should include:

Electronic approvals
Version control
Automatic review notifications
Automatic archiving of obsolete documents
Ability to attach unlimited files of any type
Links to next steps, such as document training
Real-time data
Audit readiness
Control of customer and supplier documents
Ability to access documents from anywhere (cloud-based)

If cost is an issue, look for an out-of-the-box system that doesn’t require customization. Take advantage of any free trials to see if the system will work for your needs.

If you’re upgrading from a more manual system, keep in mind that moving document management to an automated system not only centralizes material resources, but also helps make more efficient use of human resources and eliminates the risk of losing documents and the need for physical storage space.

ISO 9001 document control software benefits

Modern ISO 9001 document control systems, like QT9’s QMS, not only include basic document control functions, but also offer features that improve document management efficiency, such as links to employee training, corrective actions and other quality control functions. ISO 9001 document control software can also generate automatic audit trails that make it faster and easier to find information come audit time.

An electronic QMS can be a total package for quality management, satisfying ISO 9001 requirements beyond document control. Additional functions generally include audit management, risk management, CAPAs, employee training, supplier management and product manufacturing functions, such as engineering changes, deviations and FMEAs.

Highlights of electronic document management:

Document approvals and signatures obtained electronically (electronic signatures)
Online collaboration and feedback
Automatic alerts when documents need approval
Automatic triggers for training on document changes
Centralized source accessible from any location
Built-in traceability and transparency
Better data security

Summary

There is a variety of options for satisfying the document control requirements of ISO 9001. Whether you choose spreadsheets and physical storage or an all-in-one electronic solution, the goal should always be to control the lifecycle of your documents in the most efficient way possible.

If you’re looking for an ISO 9001 document control system that centralizes documents into one location and that is accessible anytime from anywhere, that offers electronic signatures and built-in traceability, check out eQMS options, like QT9 QMS.

ISO 9001 document control should not be a drain on your operations, your staff or your bottom line. Once document management is taken in hand, it will help ensure the quality and safety of your business.