ISO 13485:2016 Active
Guest
·
Role
v1.0
ORG-002
Responsibility and Authority Matrix
Approved
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 1 — Policy
Author
Management Representative
Owner
Management Representative
ISO Clause
5.5.1–5.5.3
Category
Organization

RACI matrix defining responsibilities and authorities across all QMS processes.

#raci#responsibility#authority
Regulatory Standards
ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Management RepresentativeInitial release