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.
Explore complete systems
Browse individual procedures or compare complete systems.
Choose your building blocks.
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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.