ISO 13485 · US FDA QMSR

Your QMS. Your Microsoft tenant. Your control.

Document control, CAPA, complaints, audits and training in one system, inside the Microsoft 365 you already use.

The product

Quzer QMS, inside your Microsoft 365

No separate SaaS holding your records. Quzer QMS is a web app that works with a SharePoint site in the Microsoft 365 you already license, so your data stays in your tenant, under your governance.

12modules
1integrated QMS
See the 12 modules
The Quzer QMS app
ISO 13485:2016US FDA QMSRISO 14971IEC 62366-1
What's inside

Your whole QMS, in three clusters

Foundation
Working Directory
Release Area
My approvals
Training
Suppliers
Purchase orders
Equipment
Compliance core
CAPA
Nonconformities
Feedback and Complaints
MDR reports
Internal audits
Review and insight
Management Review
Dashboard
Your data

Your records never leave your Microsoft 365

Most QMS tools keep your records on the supplier's servers. Quzer QMS works the other way round. The app comes to your data, and your data stays where it is.

  • Quzer stores none of it. Documents and records are saved in your own SharePoint site.
  • Microsoft sign-in. People use the work account they already have.
  • Only what you may see. The app opens only what the signed-in person can already open in SharePoint.
  • You stay in control. Your IT admin approves the app once and can remove it at any time.
Your Microsoft 365 tenant
Microsoft sign-in
QMS SharePoint site
Working Directory
Release Area
Record lists
Project sites
How it works

One workflow, reused across all modules

01 · Create

A record is added and gets its own number from the module's counter.

02 · Send for approval

To the people you choose, in a fixed order when you need one.

03 · Approve

Each approver signs with name and date, and can add a comment.

04 · Track

Status, version history, linked records and reminders on every record.

Why Quzer

Consultants who also built the system

We spent years inside other companies' QMS tools, fixing audit findings and undocumented workarounds. Quzer QMS is the system we wished we'd had.

The Quzer team
Services

Four practice areas

See it on your own documents

Tell us where you're starting from and we'll set up a demo around it.