ISO 13485:2016 Active
v1.0
Document Number
SW-006
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
QA Engineer
Owner
QA Engineer
ISO Clause
IEC 62304 5.6
Tier Level
Tier 2 — SOP/Plan

Integration test specifications for software units, software items, and system-level integration.

#integration-testing#testing
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
IEC 62304:2006+A1:2015ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026QA EngineerInitial release