Document Number
QM-001
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Quality Management Representative
Owner
Management Representative
ISO Clause
4.2.1, 4.2.2, 5.1–5.6
Tier Level
Tier 1 — Policy
Primary QMS entry point. Establishes the Quality Management System for Osteofy Bone Mineral Density Analysis System SaMD.
#quality-manual#qms-foundation#iso-13485
Approval Status
ApprovedEffective: May 7, 2026
Regulatory Standards
ISO 13485:201621 CFR Part 820EU MDR 2017/745
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Quality Management Representative | Initial release |