ISO 9001 QMS process templates (6 linked flowcharts)
Six linked flowcharts for an ISO 9001 quality management system: CAPA, customer complaints, internal audit, root cause analysis, change control and document control — connected as the cycle they actually form.
A quality management system is not a chain of procedures but a loop: complaints and audits feed CAPA, CAPA hands out investigations and takes them back, and its actions reach production through change control and the controlled procedure through document control.
What's in the package
1. CAPA process flowchart (corrective and preventive action)
The hub every other process routes into: raise, investigate, act, verify, close.
2. Customer complaint process flowchart
The external input — how a complaint becomes a quality record rather than an email.
3. Internal audit process flowchart template
The internal input: audit programme, findings, and the escalation of a nonconformity.
4. Root cause analysis process flowchart
The investigation CAPA hands out and takes back — five whys, fishbone, and the evidence test.
5. Change control process flowchart
How an agreed corrective action actually reaches production, with impact assessment.
6. Document control process flowchart
How the change reaches the controlled procedure, its version, and everyone trained on it.
How they connect
- Customer complaint process flowchart → CAPA process flowchart (corrective and preventive action)
- "Raise corrective action (CAPA)" is where a complaint stops being customer service and becomes a quality record. Not every complaint crosses this line, which is why it is a decision point in the complaint chart and an entry point in CAPA's.
- Internal audit process flowchart template → CAPA process flowchart (corrective and preventive action)
- "Agree root cause and corrective action" is the point at which an audit finding leaves the audit process. Auditors do not own the fix — they own the finding — and the link is where that ownership transfers.
- CAPA process flowchart (corrective and preventive action) → Root cause analysis process flowchart
- "Determine the root cause" is one box in the CAPA chart and the entire subject of another. Linking rather than inlining is what stops every CAPA record from containing a different, ad-hoc investigation method.
- Root cause analysis process flowchart → CAPA process flowchart (corrective and preventive action)
- "Open CAPA record and assign owners" closes the loop back. Together with the link above this is a genuine cycle — the one structure a single flowchart cannot express without either duplicating the investigation or drawing an arrow that leaves the page.
- CAPA process flowchart (corrective and preventive action) → Change control process flowchart
- "Implement the agreed actions" is where a corrective action meets reality. If the action changes a process, a specification or a system, it goes through change control rather than straight into production.
- CAPA process flowchart (corrective and preventive action) → Document control process flowchart
- "Update documents and retrain staff" is the step most CAPA records mark complete without doing. Linking it to document control makes the version bump and the training record part of the same trail.
How it works
Start at CAPA and check the escalation criteria
Both inputs branch on whether something is significant enough to raise a CAPA. Those criteria are the most-argued part of any QMS — write yours into the decision boxes before circulating the charts.
Walk the CAPA to root-cause loop with a closed record
Take a CAPA you closed last quarter and follow it round the loop. If the investigation you actually did is not what the root-cause chart describes, one of the two is wrong and it is usually the chart.
Set your verification-of-effectiveness rule
The CAPA chart's closing branch checks that the action worked. Put a real interval and a real measure on it — a QMS that closes CAPAs on completion rather than on effectiveness will keep reopening the same one.
Enable approvals on document control first
Document control is the chart whose own process demands version history and sign-off. Turning on the approval workflow there makes the chart obey the procedure it describes.
Add your registers as the seventh chart if you need them
Some auditors want the CAPA register and the document register drawn too. They fit the same folder and link from the same boxes.
Frequently asked questions
Is this an ISO 9001-certified template set?
No such thing exists — certification applies to an organisation's system, not to a document. These six charts cover processes ISO 9001 requires you to define, in the shape most quality systems use, and they are a starting point for your manual rather than a substitute for it.
Do I need a paid plan for this?
Yes — template packages are included with Plus. A package creates six charts at once, and the free plan holds three. Every member is also available on its own for free.
Why is root cause analysis a separate chart?
Because CAPA is not the only process that needs it — deviations, complaints and incidents all do. Keeping it separate means one documented method that several processes point at, instead of a slightly different investigation described inside each.
Can I use this for ISO 13485 or IATF 16949 instead?
The six processes are common to all three standards, but the sector standards add requirements these charts do not cover — risk files and design controls for 13485, PPAP and control plans for 16949. Treat this as the common core and add what your standard requires.
What does the CAPA to root-cause cycle look like in the editor?
The CAPA chart's investigation box carries a badge that opens the root-cause chart, and that chart's closing box carries a badge back. You can navigate the loop in either direction, which is what makes it readable as a cycle rather than a chain.
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