ISO 13485:2016 Active
Guest
·
Role
v1.0
DOC-001
Document Control Procedure
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
4.2.3
Category
Documentation

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

#document-control#sop#revision
Regulatory Standards
ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Management RepresentativeInitial release