ISO 13485:2016 Active
v1.0
DocumentsOrganizationORG-003
Document Number
ORG-003
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
CEO
Owner
CEO
ISO Clause
5.5.2
Tier Level
Tier 1 — Policy

Formal appointment of the Quality Management Representative with defined responsibilities and authorities.

#management-rep#appointment
Approval Status
Approved
Effective: May 7, 2026
Regulatory Standards
ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026CEOInitial release