Document control is the process that defines how an organisation's policies, procedures, instructions, forms and records are created, approved, distributed, changed and retained. Its goal is simple: everyone uses the current, approved version of a document while doing their work, and evidence of what was done in the past is kept without being lost. This guide brings together templates and checklists that turn ISO 9001:2015 clause 7.5 into daily practice.
What does ISO 9001 require for documented information?
ISO 9001:2015 merges the earlier distinction between “documents” and “records” into a single concept: documented information. The standard does not mandate a quality manual or a specific number of written procedures by name. Instead it defines two kinds of documented information: information the standard explicitly requires, and information the organisation determines is necessary for the effectiveness of its quality management system (clause 7.5.1).
In the standard's wording, “maintain documented information” refers to documents kept up to date, such as procedures and instructions. “Retain documented information” refers to records that are evidence an activity was carried out. This distinction sets the difference between revision management and protecting records against change.
- Policy, procedure, instruction
- Revised, version changes
- Current version must be available
- Inspection, training, audit record
- Not changed once created
- Protected for the retention period
- Clause 7.5.2 (creating and updating): appropriate identification and description (such as title, date, author or reference number), appropriate format and media, and review and approval for suitability and adequacy.
- Clause 7.5.3.1 (control): information must be available and suitable for use where and when it is needed, and adequately protected from loss of confidentiality, improper use or loss of integrity.
- Clause 7.5.3.2 (activities): distribution, access, retrieval and use; storage and preservation, including preservation of legibility; control of changes (for example, version control); retention and disposition.
- Documented information of external origin: what the organisation needs for planning and operation must be identified as appropriate and controlled.
- Information retained as evidence of conformity must be protected from unintended alterations.
The standard says “what” must be achieved and leaves “how” to the organisation. Using paper, shared folders or a document management system is not in itself conformity or non-conformity; what matters is that the controls above work and can be proven.
Document hierarchy
A hierarchy makes clear which document defines what and what level of approval it needs. The structure below is a common example; the standard does not require a specific hierarchy, and you can merge levels to suit the size of your organisation.
- PolicyIntent and direction
- ProcedureWho, what, when
- Work instructionHow a task is done
- Form and templateBlank, controlled frame
- RecordCompleted form, evidence
| Level | Question it answers | Typical approver |
|---|---|---|
| Policy | What do we do and why? | Top management |
| Procedure | Who runs the process, in what order? | Process owner and quality manager |
| Work instruction | How is a task done step by step? | Department lead |
| Form and template | What information is recorded, in what format? | Process owner |
| Record | What was done, and what was the result? | Not approved; integrity is protected |
Numbering and metadata template
Every controlled document should have a unique identifier and a consistent set of metadata. Numbering should show the document type and the owning process at a glance, but not be so detailed that it loses meaning when the organisation changes. An example structure: type code, process code and sequence number (for example PR-SAL-003 or WI-PRD-014). The revision number is not part of the identifier; it is a separate field.
| Field | Description | Required |
|---|---|---|
| Document no. | Unique identifier, never changes | Yes |
| Title | Short, consistent with content | Yes |
| Type | Policy, procedure, instruction, form | Yes |
| Process owner | As a role, not a person's name | Yes |
| Revision no. and date | Increases with each approval | Yes |
| Author, reviewer, approver | Role and date | Yes |
| Change summary | What changed in this revision | Yes |
| Review period | Next review date | Recommended |
| Distribution list | Role or department | Recommended |
| Confidentiality class | Public, internal, confidential | Recommended |
Document lifecycle
A document passes through defined states from first draft to archive. Who made each state change, and when, should be recorded. Defining the states clearly takes the question “is this document in force?” off the table.
- 01Draft
The author writes the content using the approved template. The draft is not in the published area users can access and is clearly marked “draft”.
- 02Review
Departments affected by the process check the content for technical accuracy, practicality and consistency with other documents. Comments and responses are recorded.
- 03Approval
An authorised role approves the document as suitable and adequate. The approver should not be the author; the approval date and identity are kept with the document.
- 04Publish and distribute
The approved version becomes available at points of use, and the previous version is withdrawn at the same time. If needed, read acknowledgement and training are started.
- 05Periodic review
The document is checked at a defined interval to confirm it is still valid. The outcome is recorded as “no change”, “revise” or “withdraw”.
- 06Obsolete and archive
A withdrawn or superseded version is removed from points of use. If it must be retained, it is marked “obsolete” and kept in the archive.
- 01Draft
- 02Review
- 03Approval
- 04Publish and distribute
- 05Periodic review
- 06Revision request
- 01
Revision control and change reasons
Revision control tracks which version of a document is current and how it differs from earlier versions. When users open a document, they should see the revision number, date and change summary. The reason for the change should also be recorded; this information is valuable in audits and in later problem-solving work.
- Corrective action: an instruction or control changed as a result of a CAPA or 8D.
- Process or equipment change: a new machine, new method or layout change.
- Regulatory or customer requirement change: a new requirement was reflected in the document.
- Organisational change: a role, responsibility or department name changed.
- Periodic review finding: outdated content was corrected.
- Editorial correction: a spelling or format fix that does not change meaning.
You can define a shorter approval path for editorial corrections, but state clearly in the procedure which changes count as “editorial”. Any correction that changes meaning must go through the full approval flow.
Change request template
Revisions should start with a change request. The request creates a shared record between the person asking for the change and the document owner, and it helps the approver understand what they are approving and why.
- Requester and date: Who asked for the change, and when?
- Related document and current revision: Which version of which document will change?
- Reason for change: Which of the reasons above applies, with the related CAPA or complaint number if any.
- Proposed change: A comparison of old and new text, or a clear summary.
- Impact analysis: Are linked forms, instructions, training or other processes affected?
- Implementation plan: Effective date, training needs, withdrawal of the old version.
- Decision: Accepted, rejected or postponed, with the rationale.
Distribution, read acknowledgement and access rights
Distribution means the approved document reaches everyone who needs it; withdrawal means the old version is removed from points of use at the same time. If printed copies are used, the location of each copy must be known and uncontrolled printouts must be clearly marked.
Read acknowledgement records that a user has seen and read the new version of a critical document. It is not evidence of competence; for documents that change behaviour or method, back it with training and an effectiveness check.
| Role | Read | Edit | Approve |
|---|---|---|---|
| User | Published version | None | None |
| Author | Draft and published | Own drafts | None |
| Reviewer | Assigned drafts | Comment | None |
| Approver | Assigned drafts | None | Assigned documents |
| Document controller | All | Metadata | Publish and archive |
Access rights should be role-based and updated when a person leaves or changes roles. For confidential documents (recipes, costs, records with personal data), keeping access logs is recommended. Confirm the retention and access rules for records containing personal data with your legal team or data protection officer.
Printed copies and shop floor use
Screen access is not always possible on the shop floor; printed copies are legitimate in that case, but they must be controlled. Controlled printed copies are numbered, their location is written on the distribution list, and when a new revision is published the old copy is collected and destroyed. Copies printed for information carry a statement such as “uncontrolled copy, check validity before use” and the print date. Where possible, giving workstations access to the current version through a screen or a QR code reduces the burden of printed copies.
External documents and records retention
External documents include standards, regulations, customer specifications, technical drawings and supplier documents. You do not write them, but you must be able to prove you use the current version. Keep a list that records, for each one, the source, current version, responsible person and how updates are tracked.
The retention period for records is set by regulation, customer contracts, product life and the organisation's own needs. The table below is a template. Fill in the period column according to your own obligations and confirm legal periods with your legal team.
| Record type | Owner | Retention period | Disposition |
|---|---|---|---|
| Inspection and test records | Quality control | Per customer and regulatory requirement | Approved destruction |
| Calibration records | Metrology | Per instrument life and requirement | Destroy after archive |
| Training and competence records | Human resources | Per regulation, confirm | Per personal data rules |
| Internal audit reports | Quality management | By organisational decision | Approved destruction |
| CAPA and complaint records | Quality management | Per product life and requirement | Approved destruction |
| Management review | Top management | By organisational decision | Approved destruction |
Migrating from shared folders to a DMS
Shared folders work for small teams, but as documents and users grow, version confusion, uncontrolled copies and approvals you cannot prove start to appear. Treat a move to a document management system (DMS) as a clean-up project so you do not carry the existing mess into the new system.
- 01Inventory
- 02Clean-upSeparate duplicates and obsolete files
- 03Metadata mapping
- 04Pilot department
- 05Bulk migration
- 06Close old foldersRead-only, then archive
OREL DMS keeps approval workflows, revision history, read acknowledgements and role-based access in one place; used together with OREL QMS, an instruction changed as a result of a CAPA stays linked to the related record. Whichever system you choose, write down how your procedure will work in the system before you migrate.
Audit readiness
Auditors usually test document control on the shop floor: they check whether the instruction at a workstation matches the current version in the system, whether a record is protected against change and whether changes were approved. Use the list below before an internal audit.
Common mistakes
The most common non-conformity is a document in use on the shop floor that does not match the current version. Behind it there are usually locally saved or printed copies, attachments circulating by email, and old versions that were not withdrawn when the new one was published.
- Writing more documents than the standard requires; procedures nobody reads.
- Not writing instructions together with the people who do the work; text that cannot be applied on the floor.
- The approver and the author being the same person.
- Increasing the revision number without writing down what changed.
- Trying to manage versions with file name suffixes like “final”, “final_v2” or “latest”.
- Changing records as if they were revisable documents.
- Not listing external documents; working with an old standard or specification.
- Granting access rights per person and not removing them when staff leave.
- Closing overdue periodic reviews in bulk as “no change” after the date has passed.
Conclusion
A good document control system works invisibly: users find the right version of the instruction they need, changes move forward approved and justified, and records are in place, intact, when they are needed. Write fewer documents that people actually use, define states and roles clearly, and test the controls regularly on the shop floor.