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YOUR ORGANIZATION. YOUR PROCEDURES.

Build a quality system
around your work.

Choose the procedures you need, recognize what you already have, and explore the price of a coordinated selection.

ISO 13485:2016
Choose the medical-device QMS documentation family.

Dual-Standard QMS
Choose integrated ISO 9001:2026 + ISO 13485:2016 documentation.

Choose the standards your organization needs. You can switch families; each selection is kept separately while this page is open.

Choose your procedures and continue to secure Wix checkout. Volume discounts apply automatically. Documents are delivered as purchased; automatic customization is not included.

Explore complete systems

Browse individual procedures or compare complete systems.

01Describe your work
02Choose procedures
03Review your selection
THE PROCEDURE LIBRARY

Choose your building blocks.

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TRY A REALISTIC SCENARIO

Explore a sample organization.

Illustrative starting selections—review for your organization. Examples use the selected standards family and replace your current selection. Package extras are included only when purchasing the complete package.

Base: 23 procedures · Design Plus: 45 · Manufacturing: 60. Expansion marks all 23 Base procedures as already covered and selects the 25 additional Design Plus procedures; three Base procedures are outside the Design Plus list.

A BETTER STARTING POINT

Tell us about your work.

We’ll suggest a starting selection you can edit. Your choices help us review your needs; source documents are not modified by this tool.

Which standards should your system support?
What activities do you perform?
Which markets are you considering?

Market choices are retained in your review. This tool does not infer device classification or market-specific obligations.

REVIEW, THEN REFINE

Your procedure selection.

Review your selection before continuing. Checkout confirms current prices and applies your discount automatically. No payment is taken until you complete Wix checkout.

0 proceduresEstimated total $0.00