LQMS¶
LQMS is a quality-management system tool for organizations working to ISO 13485 — a software house building medical-device software, a manufacturer, a supplier in someone else's device file. It manages controlled documents through configurable lifecycles, keeps several customers' and projects' data separated by construction, and makes every released state, approval and change reconstructible for an audit.
It does not ship your QMS content. Your SOPs, work instructions, templates and records stay yours; LQMS is the machinery that governs them.
Start with the tutorial¶
The tutorial walks you from an empty installation to a released, reviewed document — the whole loop, in order, with nothing assumed. It is the fastest way to find out whether LQMS fits the way your organization actually works.
Then the user guide covers the rest: projects and scopes, the document lifecycle, review policies and obligations, traceability, training records, exports and the administration surfaces.
What you will find here¶
| Tutorial | The guided first run, start to finish. |
| User guide | Everything else, by topic. |
| Documents and their lifecycle | Draft, review, approval, release, revocation — and who may do what. |
| Traceability workspace | Linking requirements, risks, tests and changes so the chain holds. |
| Obligations | Periodic reviews, training and the things that come due. |
| Administration | Scopes, memberships, key rules, the setup wizard. |
Evaluating LQMS, or auditing it¶
This site is the user documentation. The evaluation and audit material — the known-limits statement, the security posture, the IEC 62304 development record and the validation package — is available on request to a customer evaluating LQMS or to an auditor assessing it. Ask, and it is provided directly.
About these pages¶
LQMS is pre-1.0. These pages are built from the same Markdown the product ships, at the version stamped in the footer of every page — including this one. Your own installation carries its own copy of this manual, versioned with your release: where the two disagree, the manual inside your installation is the one that is right.