ISO 13485:2016 Active
v1.0
DocumentsDocumentationDOC-002
Document Number
DOC-002
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Management Representative
Owner
Management Representative
ISO Clause
4.2.4, 4.2.5
Tier Level
Tier 1 — Policy

Requirements for the identification, collection, storage, retrieval, and retention of quality records.

#record-control#quality-records#retention
Approval Status
Approved
Effective: May 7, 2026
Regulatory Standards
ISO 13485:201621 CFR Part 11

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Management RepresentativeInitial release