Stage 04 · Medical Device Track

Quality System

Establish the QMS, then operationalize one of its most-audited pillars.

A Quality Management System isn't an artifact you produce once and file away — it is the operating discipline that turns a design into a manufactured product. Stage 04 sets up the QMS framework (12 standard procedures across 9 pillars, aligned to 21 CFR 820 + ISO 13485), then drills into Supplier Qualification, the single most audit-cited area in medical device QMS deficiencies. Both deliverables become inputs to the 510(k) (Section 19, Manufacturing Information) and to any future Notified Body audit.

Cards below are arranged in chronological use order. Step numbers reflect the recommended sequence; an experienced practitioner may interleave or revisit cards as needed, but a first pass through this stage should follow the order shown.

Step 1

Active

QMS Bootstrap

Templated procedures for Document Control, Management Review, CAPA, Internal Audits, Supplier Controls, Training, Production Controls, Servicing. Adopt-and-adapt model — faster and safer than writing from scratch. 21 CFR 820 + ISO 13485:2016.

Launch Tool

Step 2

Active

Supplier Qualification & Controls

Supplier inventory with three-question risk classification (Critical/Major/Minor), qualification workflow, Quality Agreement template builder with editable RACI matrix, incoming inspection plan per 21 CFR 820.80(b), change notification + SCAR registers, ongoing surveillance scorecard with green/yellow/red heatmap. Single most audit-cited area in medtech QMS.

Launch Tool