ISO 13485:2016 Active
v1.0
DocumentsOrganizationORG-002
Document Number
ORG-002
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Management Representative
Owner
Management Representative
ISO Clause
5.5.1–5.5.3
Tier Level
Tier 1 — Policy

RACI matrix defining responsibilities and authorities across all QMS processes.

#raci#responsibility#authority
Approval Status
Approved
Effective: May 7, 2026
Regulatory Standards
ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Management RepresentativeInitial release