Document control: review, approve, prove
Review and approve procedures, work instructions and forms, with deadlines and a complete audit trail.
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What is document control?
Document control is the managed handling of the documents a company works by. Each document has a unique identifier, is reviewed and approved before use, changes go through a new revision, and only the current approved version is valid. ISO 9001 requires this in clause 7.5. The aim: nobody works from an outdated version.
Controlled documents and records
Controlled documents (requirements)
They define how work is done: quality manual, process descriptions, procedures, work and inspection instructions, form templates. They change over time, so they need revisions, review and approval.
Records (evidence)
They show what was done: completed inspection reports, audit reports, training records. Records are not changed afterwards, they are retained.
Capture audits and inspection reports with FlowNavi →What ISO 9001 clause 7.5 requires and how FlowNavi covers it
The standard does not prescribe software. It requires documented information to be identified, reviewed, approved, kept current and protected. This is how FlowNavi maps each requirement:
ISO 9001 7.5.2 a
Identification and description
coveredDocument number built from the document type code and a number, such as VA4 or VA4-1, or free numbering. FlowNavi rejects duplicate numbers. Plus title, department and scope.ISO 9001 7.5.2 c
Review and approval
coveredTwo stages: review first, then approval, each by people or groups and with a deadline.ISO 9001 7.5.3.2 c
Control of changes
coveredEvery change is a new revision with a mandatory change description. Approved revisions can no longer be edited.ISO 9001 7.5.3.1 a
Available and suitable where needed
coveredThe most recently approved revision is the valid one. Periodic review flags documents whose review cycle has run out.ISO 9001 7.5.3.1 b, 7.5.3.2 a
Protection and access
coveredPermissions by status: people with read access see approved versions. Drafts and the archive have their own permissions.ISO 9001 7.5.3.2 d
Retention and disposition
coveredOlder revisions stay in the revision list, documents that no longer apply are archived. The audit trail shows who did what and when.- All 6 requirements of clause 7.5 covered
| Clause | Requirement |  In FlowNavi |
|---|---|---|
| 7.5.2 a | Identification and description | coveredDocument number built from the document type code and a number, such as VA4 or VA4-1, or free numbering. FlowNavi rejects duplicate numbers. Plus title, department and scope. |
| 7.5.2 c | Review and approval | coveredTwo stages: review first, then approval, each by people or groups and with a deadline. |
| 7.5.3.2 c | Control of changes | coveredEvery change is a new revision with a mandatory change description. Approved revisions can no longer be edited. |
| 7.5.3.1 a | Available and suitable where needed | coveredThe most recently approved revision is the valid one. Periodic review flags documents whose review cycle has run out. |
| 7.5.3.1 b, 7.5.3.2 a | Protection and access | coveredPermissions by status: people with read access see approved versions. Drafts and the archive have their own permissions. |
| 7.5.3.2 d | Retention and disposition | coveredOlder revisions stay in the revision list, documents that no longer apply are archived. The audit trail shows who did what and when. |
All 6 requirements of clause 7.5 coveredThe life cycle of a document
Every document has one of four statuses. The status decides who can see it and what can be done with it.
1
Draft
The author writes or changes the document. Readers do not see drafts. Submitting is a separate permission, so writing and submitting can sit with different people.
2
Review
Reviewers check the content. If someone rejects it, the document goes back to draft with a comment, and the history shows at which stage it was rejected.
3
Approved
Once approved, the revision is valid and can no longer be edited. To change anything, you create a new revision.
4
Archived
Documents that no longer apply are archived. They keep their history, and viewing the archive needs its own read permission.
Approval workflow with deadlines
Approval has two fixed stages: review first, then approval. When submitting, you pick people or groups for each stage and a deadline in days. The approval deadline starts as soon as the review is complete.
- Set deadlines once for the whole account or separately per document type.
- Default reviewers and approvers are filled in when you submit.
- Self-selection can be blocked: whoever submits cannot then pick themselves as reviewer or approver.
- "My approvals" collects each person's open reviews and approvals, and a counter in the menu shows how many are waiting.
- Administrators can switch to all open tasks in the company and see where things are stuck.
Reviewers and approvers find their open tasks under "My approvals".
Revisions and reason for change: who changed what, and why
A change starts with a new revision. The change description is mandatory; without it, no revision can be created. As a starting point you take the approved file or upload a new one.
While Rev. 4 is being edited or reviewed, Rev. 3 stays valid. Nobody works from a half-finished draft, and there is no gap between the old and the new version.
The audit trail records every status change, plus changed details with old and new value, the person, the time and the comment.
Periodic review: no more outdated procedures
Even a document nobody changes needs a regular check: is the process still right, does the department it names still exist? For that you set a review cycle in months, for the whole account, per document type or for a single document.
FlowNavi works out the next review date and marks documents as "due soon" or "overdue". If the document is still current, you confirm the review with one click: the document stays as it is and the cycle starts again. If it needs changes, you create a new revision.
Related documents: see what a change affects
A procedure refers to forms and inspection instructions, and is itself named in the quality manual and in process descriptions. In FlowNavi you record these references on the document.
The References tab shows both directions as a list and as a map: what the document refers to and which documents refer to it. Before you change VA-04, you see that the complaint form FB-12 and the inspection instruction AA-07 depend on it and may need a review too.
Edit Word documents right in the browser
You edit DOCX files right in the browser, starting from a template library if you like. Readers get a PDF preview, and PDFs and other files can be controlled as well.
Try the live demo above ↑Example: procedure VA-04 from Rev. 3 to Rev. 4
An internal audit finds that returned goods are not inspected when handling complaints. The procedure VA-04 Complaint handling therefore gets an additional inspection step.
S. Becker from quality management creates Rev. 4 with the change description "Added incoming goods inspection step". She takes the approved file as the starting point and adds section 4.3 in the browser.
The References tab shows her that the complaint form FB-12 depends on VA-04. When submitting, she writes in the comment: "Please check FB-12 as well."
Review by M. Kraus, deadline 5 days. Approval by Dr. Lenz, deadline 3 days.
M. Kraus finds VA-04 under "My approvals", reads it and completes the review. That starts the deadline for Dr. Lenz.
Dr. Lenz approves. From now on Rev. 4 applies; until then, Rev. 3 did. The old revision stays in the revision list.
The audit trail lists every step with person, time and comment. When the auditor asks about the change, you show this one page.
Spreadsheet vs. software
Valid version
- Spreadsheet and file share
- Somewhere in the folder, often with "final_new" in the file name
- FlowNavi
- Exactly one approved revision, older ones in the revision list
Review and approval
- Spreadsheet and file share
- Signature on paper or by email, hard to find later
- FlowNavi
- Two stages with people or groups and deadlines, all in the audit trail
Reason for change
- Spreadsheet and file share
- A column, if someone remembers
- FlowNavi
- Mandatory field on every new revision
Periodic review
- Spreadsheet and file share
- A date in the list that nobody looks at
- FlowNavi
- Review cycle with "due soon" and "overdue" markers
Dependencies
- Spreadsheet and file share
- Buried in the text, nobody sees them at a glance
- FlowNavi
- References in both directions as a list and a map
Access
- Spreadsheet and file share
- Folder permissions, drafts sit next to valid versions
- FlowNavi
- Permissions by status, readers see approved versions
Duplicate numbers
- Spreadsheet and file share
- Often noticed only during the audit
- FlowNavi
- Rejected when the document is created
| Topic | Spreadsheet and file share | FlowNavi |
|---|---|---|
| Valid version | Somewhere in the folder, often with "final_new" in the file name | Exactly one approved revision, older ones in the revision list |
| Review and approval | Signature on paper or by email, hard to find later | Two stages with people or groups and deadlines, all in the audit trail |
| Reason for change | A column, if someone remembers | Mandatory field on every new revision |
| Periodic review | A date in the list that nobody looks at | Review cycle with "due soon" and "overdue" markers |
| Dependencies | Buried in the text, nobody sees them at a glance | References in both directions as a list and a map |
| Access | Folder permissions, drafts sit next to valid versions | Permissions by status, readers see approved versions |
| Duplicate numbers | Often noticed only during the audit | Rejected when the document is created |
Frequently asked questions about document control
Do I need document control software for ISO 9001?
No. The standard requires controlled documents, not a particular tool. A spreadsheet with a file share can be enough if someone maintains it carefully. Software pays off once you have many documents, several reviewers or sites, and need to show approvals and reasons for change anyway.
What are controlled documents?
Documents that define how work is done and are therefore reviewed and approved before use: quality manual, process descriptions, procedures, work and inspection instructions, and form templates. Completed forms and reports, on the other hand, are records.
How often should controlled documents be reviewed?
The standard sets no interval. Many companies review every one to three years, depending on how often the process changes. In FlowNavi you set the review cycle in months, for the account, per document type or per document.
What happens to old revisions?
They are kept. An approved revision can no longer be edited. When a new one is approved, the old one stays in the revision list with its change description and its history in the audit trail.
Which plan includes document control?
It is part of the Enterprise plan. You can also use document control on its own, without forms and jobs. Pricing is on request, easiest after a short demo.
Can I bring in existing documents?
Yes. You upload the files and assign the numbers. An existing document structure with references can be created with the Markdown import: one file per document, the file name is the number, and references are written as [[FB-12]] in the text.