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Quick Start

Prerequisites

  • A GitHub organization (Free, Team, or Enterprise)
  • GitHub CLI installed and authenticated
  • Admin access to your organization

Step 1: Create your QMS repository

# Option A: Use as template
gh repo create my-org/qms --template IridiumSoftware/open-qms --private

# Option B: Fork
gh repo fork IridiumSoftware/open-qms --org my-org --fork-name qms

Step 2: Run setup

git clone git@github.com:my-org/qms.git
cd qms
./scripts/setup.sh

This configures branch protection, creates QMS labels, and verifies issue templates.

Step 3: Configure your organization

  1. Edit CODEOWNERS with your team structure
  2. Edit docs/qms-config.yml with your organization details and trainee list
  3. Copy documents from templates/ to your repo root as starting points

Step 4: Enable document rendering

  1. Go to Settings > Pages
  2. Set Source to "GitHub Actions"
  3. The deploy-docs.yml workflow will publish your QMS as a browsable site

Step 5: Start using it

  • Create a document: Branch from main, add your document using a template, open a PR
  • Log a CAPA: Use the CAPA issue template
  • Request a change: Use the Change Request issue template
  • Release: Tag with v* to trigger the release gate

Step 6: Validate

Open QMS provides infrastructure, not a validated system. You must validate the system for your intended use. See the validation guidance for what to cover.