$197 — Entry Tier

QMS Foundations Pack: Document Control, Training & Management Review

Essential QMS foundation templates: document control, training records, and management review procedures. Perfect starting point for FDA 21 CFR 820 and ISO 13485 compliance.

Get the Toolkit — $197

7-day money-back guarantee • One-time purchase • Instant download

What's Included

Document Control Procedure (SOP)
Document Change Request Form
Training Procedure (SOP)
Training Matrix Template
Training Record Form
Management Review Procedure (SOP)
Management Review Agenda Template
Management Review Minutes Template
Quality Objectives Tracking Form

Benefits

Establish core QMS infrastructure in days, not months
FDA 21 CFR 820 and ISO 13485 compliant templates
Save 40+ hours vs creating from scratch
Ready for immediate implementation

Is This For You?

This toolkit is designed for teams facing these challenges:

No formal document control system in place
Training records scattered or incomplete
Management reviews not happening or poorly documented
Starting QMS from scratch and overwhelmed

Who This Is For

Startups building their first QMSCompanies formalizing informal processesQA managers establishing foundational procedures

Frequently Asked Questions

Is this enough to pass an FDA inspection?

This covers foundational elements. Most companies also need CAPA, design controls, and other procedures depending on their device type.

Are these QMSR-compliant?

Yes, templates are aligned with current Part 820 and upcoming QMSR requirements.

Related Toolkits

CAPA System

$247

Design Controls

$247

QMSR Transition

$247

Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $197

7-day money-back guarantee