ISO 13485:2016 Active
v1.0
DocumentsDocumentationDOC-001
Document Number
DOC-001
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Management Representative
Owner
Management Representative
ISO Clause
4.2.3
Tier Level
Tier 1 — Policy

Requirements for creation, review, approval, issuance, revision, and retirement of all QMS documents.

#document-control#sop#revision
Approval Status
Approved
Effective: May 7, 2026
Regulatory Standards
ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Management RepresentativeInitial release