ISO 13485:2016 Active
Guest
·
Role
v1.0
RM-005
Hazard List
Draft
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
ISO 14971:2019
Category
Risk Management

Consolidated hazard inventory with hazard IDs, descriptions, hazardous situations, and harms.

#hazard-list#hazards#inventory
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release