Quality Management System

Your whole QMS, connected

Quality events, CAPA, risk, change, documents and training — six modules that share one record, so an issue on the line flows through to the fix, the SOP and the retrained team without leaving the system.

Six modules, one record

An event raises a CAPA, drives a change, revises the document and retrains the people — linked end to end.

Quality eventsCAPARiskChangeDocumentsTraining
Every disposition, priced

Use-as-is, rework, repair, scrap, return to supplier or downgrade to 2nd quality — per line, with cost and signed approval.

ReworkScrap2nd qualityUse-as-is
Approvals everywhere

Simple or guided sign-off with e-signatures — sequential, parallel or quorum, set per record type.

e-signatureSequentialQuorum · 2 of 3
Quality events

Catch, contain and cost every issue

Quick-capture on the floor — a photo and a line, raised straight on the purchase, production or sales order it happened on. Disposition the affected quantity through a material-review-board matrix, and capture what the failure actually cost: scrap, rework, shipping.

CAPA

Corrective actions that actually close

Pick the rigour per case: Lightweight for a free-text root cause, Standard for 5-Whys with separate corrective and preventive actions, Comprehensive for Fishbone with risk scoring and cost tracking. Suppliers respond via a public link — and nothing closes until the fix is proven effective.

One connected record

Every module feeds the next

An issue on the line doesn't stop at a form — it flows through containment, the corrective action, the change, the revised SOP and the retrained team, linked end to end.

  1. 01

    Inspection fail

    A failed check, audit finding or customer return raises a quality event — straight from the floor.

  2. 02

    Event contained

    Immediate action logged, affected quantity dispositioned through the MRB matrix, cost captured.

  3. 03

    CAPA verified

    Root cause found and the fix proven effective — at the rigour the case deserves.

  4. 04

    Change released

    The permanent fix goes through impact assessment, change-board approval and a controlled release.

  5. 05

    SOP revised

    The controlled document gets a new version — reviewed, e-signed and made effective.

  6. 06

    Team retrained

    The revision trace shows exactly who needs retraining — and the skills matrix confirms when they are.

Nothing dead-ends

Each record links to the next, so the loop from problem to prevention is visible — and auditable.

Suppliers in the loop

Supplier CAPAs run over a secure public link — no login, no licences, full evidence trail.

Repeat events surface

New events auto-match similar open issues, so a recurring problem escalates instead of hiding.

Risk management

Risk you actually keep current

Score likelihood × severity on your own versioned matrices. Red risks can't be accepted until a treatment is active, a review clock flags stale ones, and the register's heatmap feeds risk-based audit planning.

Document control

One source of truth for every SOP

Controlled versions with e-signature and an effective date, a read-and-understood roll-call per document, and a clause-coverage matrix that maps your SOPs to the standard — and flags the gaps.

Change management

Change, under control

Every impact dimension — documents, products, training, risk — addressed or waived before submit. A major change convenes the change control board, releases in controlled steps and is verified before close.

Training & competency

The right people, proven qualified

Role profiles bundle the skills a job needs. The skills matrix shows unit readiness at a glance, flags qualifications expiring 30/60/90 days out — and when an SOP changes, the revision trace shows exactly who needs retraining.

Analytics & reporting

The numbers, live and explained

A quality-events cockpit and four CAPA report views — with every formula documented in the product, so nobody argues about how a number was computed.

  • Open-event funnel, aging brackets and disposition mix — including cost of poor quality in your currency.
  • CAPA on-time closure, first-pass approval and effectiveness rates, filterable by date, source and severity.
  • Weekly module digests and a daily 'my CAPAs' email keep owners moving without logging in.
Built to answer the clauses your customers audit you against —
ISO 9001 · 8.710.2 Corrective action7.5 Documented information7.2 Competence6.1 Risk-based thinking

See the whole loop in one demo

Book 30 minutes and we'll walk your own process through it — from a nonconformance on the line to the retrained team.

Why Link SE

A QMS your whole factory can run on

Not a document graveyard — a working system that connects the floor, the quality team and the board.

One record, six modules

Events, CAPA, risk, change, documents and training share one linked record — no re-keying, no version chaos.

Built for the factory floor

Log a nonconformance at the line with a photo — raised on the order, matched to similar issues automatically.

Cost of quality, quantified

Scrap, rework and shipping priced on every event and rolled into a cost-of-poor-quality view your board can read.

2nd quality built in

Downgrade is a first-class disposition — record the value impact and route its approval separately.

Always audit-ready

Evidence, e-signatures, document versions and training records in one place — hand your auditor a link, not a binder.

Approvals that fit

Sequential, parallel or quorum sign-off per record type, with escalation when a step goes overdue.

How manufacturers run it

Four everyday loops, from the line to the standard.

01

The delaminated tabletop

Final inspection finds edge delamination on 7 of 40 oak tops. The event is raised on the production order, the batch quarantined, 7 tops scrapped at a recorded cost — and the press cool-down SOP revised.

02

Stitch defect, saved margin

A stitching fault splits the lot: 300 pairs reworked, 50 downgraded to 2nd quality with the value impact recorded — every line signed off with its own approval.

03

The repeat offender

A veneer supplier raises its third NCR in 60 days. The pattern surfaces automatically, a supplier CAPA goes out via public link, and the effectiveness check keeps it honest.

04

The SOP that retrains

A revised inspection procedure goes effective. The revision trace lists exactly who was trained on the old version — and the skills matrix tracks them back to qualified.

Frequently Asked Questions

QMS FAQ

Do we have to roll out all six modules at once?

No. Each module works on its own — many teams start with quality events and CAPA, then add risk, change, documents and training as processes mature. The link between records is there whenever you switch a module on.

Can suppliers work on corrective actions without a licence?

Yes. Supplier CAPAs run over a secure public link — the supplier sees the finding, responds with evidence and submits, all without a login. The full exchange lands on the record.

How does the system handle selling B-grade or 2nd-quality product?

Downgrade is a built-in disposition alongside rework, repair, scrap, use-as-is and return to supplier. You disposition part of a quantity to 2nd quality, record the estimated value impact, and route its approval separately if you want tighter control.

Does it track what poor quality actually costs?

Yes — scrap, rework and shipping costs are captured on quality events per line, and roll up into cost-of-poor-quality reporting by product, supplier and over time.

Is it suitable for ISO 9001 certification?

The modules map to the clauses auditors check: nonconforming outputs (8.7), corrective action (10.2), documented information (7.5), competence (7.2) and risk-based thinking (6.1) — with the evidence trail kept for you.

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30-minute walkthrough