HR-001
Human Resources and Training Procedure
Version
v1.0
Effective Date
May 8, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Management Representative
Owner
Management Representative
ISO Clause
6.2, 4.2.5
Category
Human Resources
Procedure for ensuring personnel competency through hiring, training, competency assessment, and personnel records management per ISO 13485:2016 Clause 6.2.
#training#competency#personnel#human-resources#iso-13485
Regulatory Standards
ISO 13485:201621 CFR Part 820EU MDR 2017/745
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 8, 2026 | Management Representative | Initial release — created in response to internal audit finding F-2026-Q1-002 |