Quality Management
Audits, corrective actions, processes and approvals in one quality system, organised around ISO 9001.
Plan and run internal audits, drive every finding to a verified corrective action, map how work should happen and prove it did, and sign off records with a real electronic signature.
Run quality as a connected system
The Quality Management module brings your audits, corrective actions, processes, approvals and records into one system, organised around a standard clause structure - so an audit finds what it expects, where it expects it. ComplyTrain structures the QMS around the standard; that describes how the software is organised, not a certification of your company or ours. The scaffolding is ours; the evidence and the audit stay yours.
Scoped requirements become controlled documents, approved processes and the recurring work that keeps them true, and each of those carries the evidence behind it. Documentation coverage and operating-process coverage stay separate views, because a written procedure and a process people actually run are two different claims.
Plan audits around what needs attention
Plan the programme, schedule the audits, run the fieldwork and act on what you find - all in one place. Higher-risk areas are scheduled more often, audits are generated automatically when they fall due, and auditors capture observations as they go, elevating the significant ones into findings mapped to the exact clause they touch. Pull approved procedures, records and training positions straight in as version-pinned evidence, so what you show is exactly what was in force at the time.
A reviewer can follow any finding back to the records it came from. When the certification body comes round, curate the evidence you choose and hand over a single verified package - no portal, no login, nothing exposed to the internet.
What it looks like
Plan an audit around its scope, objectives and evidence. Evidence, findings and sampling each have their own tab.
Use cases
First-time ISO 9001
A supplier standing up a quality system for the first time gets the clause structure, the record types, the audit cadence and the approval routes out of the box - not a blank SharePoint.
Surveillance without the scramble
Findings, corrective actions and their evidence are already linked and version-pinned, so the annual surveillance audit is a walk through live records, not a fortnight of retrieval.
From finding to fix, on the record
An internal audit raises a finding; one step turns it into a corrective action with a structured root cause, verified by a second person and closed only once it has passed your gates - the whole chain traceable end to end.
Sign-off you can prove
Approvals are captured as electronic signatures against a specific version, made on the approver’s own device and held back until their training is current - the evidence is on the record, not in an email you have to find.
One quality system, built around the standard
Audit programme
Plan, schedule and run your internal audits, map findings to real clauses, and turn each one into a corrective action in a single step.
Audit managementCorrective actions (CAPA)
Structured root-cause analysis, typed actions and a separate verification step - closure gated by the evidence and sign-off your process demands.
CAPA and root causeApproved processes
Version-controlled definitions with a named owner on every step, run as numbered records that capture evidence as the work happens.
Quality process automationSigned approvals & records
Electronic signatures on your own certificates, approval gated on current training, and a tamper-evident audit trail you can verify in one click.
Management review
Reporting periods, reviewed inputs and dated decisions with an owner, so a review produces follow-up work rather than minutes.
Management reviewsGuided or manual setup
Choose your standards and scope, then let AI propose the structure or configure it yourself. Every AI proposal is accepted or rejected by a person.
Implementing a QMS
Corrective and preventive action
Follow the problem through to verified action
A corrective and preventive action here is a real record, not a to-do with a label. Each CAPA carries its source, a structured root-cause analysis, typed containment, corrective and preventive actions, the evidence behind them and its full history. Severity sets the clock, so a critical issue gets a tighter containment and analysis deadline automatically.
Completing an action and verifying it are two separate acts by two people, so "we finished it" can never stand in for "someone checked it worked". AI can suggest a root cause or a corrective action; a person always commits it.
- Structured root-cause analysis - 5 Whys, Fishbone and more - not a free-text box
- Containment, corrective and preventive actions typed and owned separately
- Closure gated by the evidence, sign-off and review your own procedure demands
- Escalation rules and workflow stages you configure to match your process
Process definitions
Turn process maps into accountable work
Describe a process in plain English and let AI draft the swimlane map; refine it in a structured editor with a live diagram you can export as an image or PDF. The map above is a saved draft: three connected steps, with the review step carrying an owner role, a five-day target and a task that cannot complete without its evidence.
Definition, approval and execution stay separate stages. Once a definition is approved and version-pinned you can run it: real people are cast onto each lane, every step captures its evidence as the work is done, and completing the run leaves a numbered, locked record. A documented process shows you know how work should happen; a completed run is dated proof that it did.
- AI drafts the swimlane map from a plain-English description; you refine and approve it
- Version-controlled definitions with a review cadence and an append-only history
- Named owner on every step, with evidence captured as the work happens
- Each completed run leaves a numbered, locked record of exactly what was done
Management review
Make management review lead to decisions
A management review in ComplyTrain is organised around its reporting period and the inputs it has to consider, and what comes out of it is a decision with a named owner and a due date rather than a set of minutes.
The review above is still in draft, which is a real business state and stays visible. What it shows is the shape of the record: the decision exists, it belongs to someone, and it is dated. Follow-up work links out to Planner, and the supporting numbers come from Reporting.
- Reporting periods with the inputs a review is expected to consider
- Decisions carry an owner and a due date, not just a line in the minutes
- Follow-up actions tracked after the meeting, not filed with it
Getting started
Start with your scope, and keep control of what AI changes
Setup begins with a choice: let AI guide the build, or configure it yourself. Either way you select the standards you work to, set the scope and the implementation targets, and draw on the templates available for that standard.
The guided path proposes; it does not decide. Every proposal - a document, a process, a mapped requirement - is accepted or rejected by a person, and a controlled document still goes through its normal approval before it means anything.
- Choose the standards and the scope the system is built around
- Per-standard onboarding with the templates available for it
- Guided by AI or set up yourself, with the same end structure
- Every AI proposal is reviewed by a person before it takes effect