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Quality (QMS)

Quality management, audit-ready by default

Controlled documents, NCRs, CAPAs, audits and suppliers — with stage-gate approvals and a complete audit trail baked in.

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OpSemble quality management controlled document register

What you get

Document control

Numbered, versioned documents with a draft-review-approve workflow and read acknowledgements.

Non-conformance reports

Raise NCRs with severity and source, investigate, disposition and close — all linked.

CAPAs

Corrective and preventive actions with owners, due dates and effectiveness reviews.

Audits & schedules

Plan internal, external and supplier audits, capture findings by clause, and repeat on a schedule.

Approved suppliers

A supplier register with approval status, quality ratings and review dates.

Audit-ready by default

Every transition is logged — who, what, when — so evidence is a filter, not a scramble.

Try the approval gates

Documents move Draft → Review → Approved, and authors can never approve their own work. Demo — sample data, resets on reload

WI-CNC-001 — CNC Machining Work Instruction
Work Instruction · v0.1
Draft
1 Draft
2 Under Review
3 Approved
Acting as:

Audit trail
    NCRs & CAPAs

    Every non-conformance, linked to its corrective action

    Raise an NCR with a description, root cause and disposition, then link it to a CAPA with an owner and due date — nothing gets closed out without evidence, and nothing falls through the cracks.

    OpSemble non-conformance reports linked to corrective actions

    Quality Management Software for Small UK Businesses

    Most small UK firms meet ISO 9001 the expensive way: a consultant writes the manual, the certificate goes on the wall, and the "system" lives in a folder nobody opens between audits. The alternative isn't a bigger folder — it's making the quality records part of how work actually happens, so the evidence writes itself.

    That's the design here. A document can't skip its approval gate. An NCR can't close without its corrective action. Supplier reviews surface when they're due. When the certification body visits, the audit trail is a filter on real records, not a fortnight of reconstruction.

    Enterprise eQMS platforms do all this too — priced for pharma. At £7 per user/month on top of the £29/month platform fee, quality stops being the module you defer. Manufacturers should also read our guide to supplier audits, inspections and document control, and see OpSemble for manufacturing for how QMS fits alongside inventory and projects.

    Frequently Asked Questions

    Does OpSemble QMS help with ISO 9001 compliance?

    Yes. Controlled document management with version tracking, approval workflows and distribution records creates the audit trail ISO 9001 auditors expect. The compliance register tracks which standards apply to your business, and you can link documents to specific clauses.

    How do NCRs and CAPAs work together?

    Raise an NCR (non-conformance) when something doesn't meet standard. Link it to a CAPA (corrective action) with assigned owner, deadline and evidence tracking. Close the CAPA when corrective actions are complete and verified, with full audit trail.

    Can I run internal audits in OpSemble?

    Yes. Create audit plans by process or system, assign auditors and auditees, run the audit with a checklist and findings, then link findings to NCRs or training needs. Track audit schedules to meet your audit frequency requirements.

    How does supplier management work?

    Record suppliers and their certifications (ISO, quality standards, etc.). Track expiry reminders, link suppliers to approved materials, and record audit results for external suppliers.

    Can I control document revisions and who accesses them?

    Yes. Version control tracks every revision with dates, authors and change logs. Approval workflows route documents to the right people. Superseded versions are archived, and you can track who's read the current version and when.

    Does OpSemble QMS integrate with other modules?

    Yes. Link QMS documents to H&S incidents and investigations, to HR training records (compliance training signed-off), and to Projects (quality gates and approval checkpoints).

    How do I evidence training on company procedures?

    Link procedures to LMS training courses. When an employee completes training on a procedure, the training record logs in HR and links to the QMS document. You can instantly report who is trained on which procedures.

    One platform. Only the modules you need.

    Quality (QMS) is one switch in your OpSemble tenant — turn it on when you need it, alongside CRM, Projects, HR, Health & Safety, Quality and Training.

    Build your plan

    Manufacturer? Read our guide to supplier audits, inspections and document control →