ISO 9001 document control requirements are a vital part of a quality management system. These requirements, found in ISO 9001 Clause 7, set the standard for how your organisation manages documented information. The procedures specify what to document, how to create, update, and control it, and who can access it.
Clause 7.5 makes it clear: documented information must be complete, accurate, and accessible to the right people. This includes documents like your quality manual, procedures, work instructions, and records.
You must control who sees those files, make sure the latest version is always in use, and ensure they’re readable and traceable. When a process changes, record who approved the document, what changed, and when. Without this, your system can quickly fall out of sync with your actual operations.
This guide walks you through the practical steps to handle document control from start to finish. You will learn to classify and store documents, manage approvals, protect access, handle changes, and train the right people to use them. By the end, you will have a clear understanding of what ISO 9001 expects, and how to apply it in your day-to-day operations.
Understanding ISO 9001 Clause 7.5: Documented Information
Clause 7.5 of ISO 9001:2015 outlines how you should manage documented information to support your quality management system. Its purpose is to ensure that your business maintains accurate, complete, and accessible information across all departments. Documented information is essential because it provides evidence that you follow processes, meet requirements, and have clearly defined responsibilities.
You’ll work with two main types of documented information: documents and records. Documents describe what people must do, including procedures, policies, and work instructions. Records, on the other hand, capture what has already happened, like completed checklists, inspection results, and training logs. Both are critical. One guides your work. The other proves you’ve done it.
ISO 9001 document control requirements apply across your entire business. From finance and sales to operations and site work, every area must control the documents and records relevant to its responsibilities. These requirements are part of how your organisation proves control, consistency, and compliance.
Following these requirements not only reduces errors and avoids rework. It also strengthens internal accountability and supports the benefits of ISO 9001 certification, including improved customer trust and greater operational reliability.
Creating and Updating Documents
Creating and updating documents is a controlled process under ISO 9001 document control requirements. Clearly identify and describe each document. That means including a title, date, author, and version number. This information helps you know what the document is, who created it, and whether it is the most current version.
You must review and approve every document before release. Check them for suitability and adequacy. That includes making sure they match your operations and meet internal and external expectations. Approval confirms that the content is accurate, complete, and aligned with your quality objectives.
Clear roles and responsibilities are critical. You must know who is eligible to create documents, who is responsible for reviewing them, and who gives final approval. Without this structure, you might miss important updates or conflicting versions may circulate.
Following these steps keeps your information accurate and reliable. Whether you’re documenting a new procedure or revising an outdated form, every team must follow the same rules. That applies to field workers, admin staff, and management alike. Controlled document creation helps you maintain order, consistency, and trust across every part of your business.
Document Control Procedures
Your Standard Operating Procedure (SOP) for document control explains how your team creates, approves, updates, and stores documents. It defines who is responsible at each stage. Review and approve documents before use. Re-approve them whenever you make changes. This prevents outdated or incorrect information from circulating in your business.
To meet ISO 9001 document control requirements, you need a reliable way to stop the unintended use of obsolete documents. Mark them clearly as “obsolete” and remove them from all active systems. Keep them only if they are necessary for reference or legal purposes.
You also need a process for handling external documents. That includes supplier specifications, legal standards, and customer requirements. You must identify, control, and make these accessible to the relevant staff.
Control of Documents is one of the six mandatory procedures of ISO 9001. By following this process, you build consistency and ensure your documentation remains accurate and compliant.
Access, Retrieval, and Use
Access to documents must be based on roles. You assign permissions so that only authorised staff can view, edit, or approve documents. This protects critical information and supports traceability. Each document must be easy to find, whether your team is in the office or on-site. Place documents on the shop floor, in vehicles, or within project files so staff follow correct procedures without delay.
Legibility is not optional. If a document is hard to read, it fails to meet the purpose. You maintain formatting, version clarity, and clear signatures. Traceability matters just as much. That means tracking when someone issued each document, who approved it, and what changes they made.
You must meet ISO 9001 document control requirements by ensuring information is accurate, accessible, and secure. These practices also support the broader ISO 9001 certification requirements that demand consistency and accountability across all operations.
Control of Changes
You need a clear process for managing changes to controlled documents. Every change must follow a formal procedure that outlines who reviews, who approves, and who carries it out. You are responsible for making sure updates are accurate, justified, and recorded.
Version control is critical. Mark each revision with a new version number or date so your team always knows which version is current. Archive previous versions, but do not use them.
Communicating changes is just as important as making them. Notify affected personnel immediately. If the change affects a procedure or compliance measure, ensure staff understand how their work needs to adjust. Record every change in a revision log, including the reason and the person authorising it.
ISO 9001 document control requirements demand traceability. Businesses seeking ISO 9001 certification in Australia must show that changes are properly handled. This prevents errors, ensures accountability, and protects the integrity of your system.
Retention and Disposal
You must retain quality records for a defined period, depending on the type of document and legal obligations. In Australia, you need to keep most business records for 5 years. This period starts from when you either got the records or completed the transactions or actions they relate to, whichever is later. You must keep some records for longer than 5 years. For example, you need to keep company records and some employee records for 7 years.
Once records become obsolete, you must dispose of them securely. Shred physical documents and permanently delete digital files to prevent misuse of confidential information. You must control and carry out disposal in a way that makes it irreversible.
Legal and regulatory requirements will vary depending on your industry. You must keep some records longer to meet insurance or legislative obligations. You must destroy others after a certain time. Review your obligations regularly.
ISO 9001 document control requirements expect you to manage this process with full accountability. Using ISO 9001 compliance software helps ensure these actions are tracked, repeatable, and consistent across your business.
Document Storage and Protection
You can store documents physically or digitally, but each method carries different risks. Physical storage demands fireproof cabinets, locked rooms, and access restrictions. Digital storage, especially cloud-based systems, offers better protection and faster access, provided you apply the right controls.
Backups are essential. You must have automated backup procedures, stored offsite or in the cloud. Test these backups regularly to ensure data is recoverable in the event of loss, corruption, or cyberattack. A strong disaster recovery plan prepares you to act quickly.
Safeguards against unauthorised access are non-negotiable. Access controls, user permissions, encryption, and audit logs must be in place. Your team needs clear rules for who can access, change, or delete documents.
Meeting ISO 9001 document control requirements means protecting your records from damage, loss, or misuse at every stage. These safeguards are part of the broader benefits of QMS, ensuring your business remains reliable, secure, and audit-ready.
Training and Awareness
You need staff who understand what they are handling. Anyone responsible for managing, updating or approving documents must receive targeted training. This includes knowing where to find the latest version, how to apply controls, and when to flag obsolete records.
You must raise awareness across all teams, not just those in administration. Everyone should understand the role of document control in quality management and the risks of poor handling.
Never assume competence. You must monitor performance, review training records, and reassess understanding regularly. Spot checks, audits and refresher sessions help close gaps early.
Meeting ISO 9001 document control requirements depends on trained staff applying consistent practices. When you commit to structured ISO 9001 employee training, your system works. Errors drop. Audits pass. Records stay accurate. That’s the result of doing the work and making sure your people are ready.
Auditing and Monitoring
You must audit your document control processes regularly. This means checking that staff follow procedures, use current versions, and store and retrieve records correctly. A strong internal audit program helps you identify nonconformities before they lead to compliance failures.
Not every issue is obvious. You are looking for missing approvals, outdated forms still in use, or restricted documents accessed by the wrong people. These gaps signal a breakdown in control. Once identified, each nonconformity needs clear corrective action, not just a workaround.
ISO 9001 document control requirements call for continuous improvement. Your audits are tools to improve how your integrated management systems function in practice. Use audit results to fix weak points, review training, or update access permissions. Every cycle strengthens your controls. When you commit to auditing and improvement, your system stays sharp and reliable — not just compliant on paper.
Interlinking with Other ISO 9001 Clauses
ISO 9001 document control requirements are not standalone. They underpin several key clauses that shape how your business operates. ISO 9001 clause 4 requires you to manage your processes in a structured way. Controlled documents help you define, apply and review those processes without confusion or inconsistency.
Clause 8 focuses on operations. You must maintain documented procedures for tasks that affect product or service quality. These procedures must be accessible, current and approved — all core functions of document control.
Clause 9.1 asks for evidence of performance. That evidence often takes the form of records you’ve stored and protected under strict control. Scattered or outdated records could mean losing visibility into what’s working and what’s not.
Finally, Clause 10 drives improvement. You use controlled documents to track issues, define corrective actions and monitor progress. Strong control supports your long-term success and explains how to maintain ISO 9001 certification in practice.
