QM-001
Quality Manual
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 1 — Policy
Author
Quality Management Representative
Owner
Management Representative
ISO Clause
4.2.1, 4.2.2, 5.1–5.6
Category
Quality Manual
Primary QMS entry point. Establishes the Quality Management System for Osteofy Bone Mineral Density Analysis System SaMD.
#quality-manual#qms-foundation#iso-13485
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 |