LivaNova: ISO 45001 & 14001 for Medical Device Manufacturing
A global medical device manufacturer covering clean room production, warehousing and field service — certified to ISO 45001 and ISO 14001 as a single integrated management system, custom-formatted to match their existing document control framework.
LivaNova
LivaNova is a global medical technology company with Australian operations spanning medical device manufacturing, warehousing and distribution, and on-site maintenance and field service support.
~3 months
ISO 45001 · 14001
Medical devices
Manufacturing, warehousing & service
The Brief
LivaNova needed an Integrated Management System certified to ISO 45001 (Occupational Health & Safety) and ISO 14001 (Environmental Management) — covering clean room medical device manufacturing, warehouse and distribution operations, and field service maintenance.
As a global business, LivaNova already had a mature document control system. The documentation had to be custom-formatted to match their existing templates, numbering and controls so it integrated cleanly with the rest of the corporate framework — while still being practical for clean room operators, warehouse staff, forklift drivers, service technicians and remote workers.
What We Delivered
An integrated documentation set covering clean room manufacturing, warehousing, conveyor operations, hazardous chemicals, working from home and on-site service — all formatted to slot into LivaNova's existing document control system.
Integrated Management System (IMS)
A unified IMS covering ISO 45001 (Occupational Health & Safety) and ISO 14001 (Environmental Management), formatted to match LivaNova's existing document control system so it dropped straight into their corporate framework.
Health & Safety Management Plan
A WHS Management Plan covering clean room manufacturing, warehousing, conveyor systems, forklift operations, hazardous chemicals and the day-to-day risks of a medical device manufacturing and distribution site.
Environmental Management Plan
An Environmental Management Plan addressing waste streams, hazardous chemicals, energy and the environmental aspects specific to medical device manufacturing, distribution and on-site maintenance.
Safe Work Procedures — Clean Room & Warehousing
Tailored Safe Work Procedures for clean room production (gowning, contamination control, equipment use) and for warehousing activities (forklifts, manual handling, racking, conveyor interaction).
Working From Home Checklists
Working-from-home risk assessment and ergonomic checklists so office and support staff working remotely are covered under the same management system as on-site teams.
HSEQ & Conveyor Inspections
Routine HSEQ inspection templates plus dedicated conveyor system inspection checklists — built to integrate with LivaNova's existing maintenance and document control workflows.
The Outcome
From kick-off to certification took approximately three months — a realistic timeframe given the breadth of operations covered and the level of custom formatting required to match LivaNova's corporate document control system.
LivaNova achieved independent third-party certification to ISO 45001 and ISO 14001 as a single Integrated Management System, with documentation that integrates cleanly into their existing framework and is practical for clean room, warehouse, service and remote staff alike.
Standards Achieved
Manufacturing, warehousing or field service operations?
If you need an integrated ISO 45001 / 14001 management system that drops cleanly into your existing document control framework, we can help you get there.