ISO, Aerospace & Medical Compliance Insurance Guide

Why Compliance Standards Matter to Insurers

Precision engineering manufacturers supplying regulated and safety-critical sectors such as aerospace, defence, automotive, rail and medical devices are expected to operate to recognised quality and compliance standards. Certifications such as ISO 9001, ISO 14001, ISO 45001, AS/EN 9100, and ISO 13485 are not just customer requirements — they also have a direct impact on how insurers assess your risk.

From an insurance perspective, compliance frameworks demonstrate process control, traceability, risk management and governance. Strong compliance reduces the likelihood of catastrophic claims and can materially influence underwriting appetite, pricing, limits and exclusions.

This guide explains how ISO, aerospace and medical compliance standards interact with insurance, what insurers look for during underwriting, and how to align your insurance programme with regulatory and certification obligations.

How Insurers Use Compliance Information

When underwriting engineering and manufacturing risks, insurers typically review compliance information alongside your proposal form. This helps them assess both frequency risk (how often things go wrong) and severity risk (how bad a claim could be).

Compliance factors insurers commonly assess

• Scope of certification (what sites, processes and activities are covered)
• Audit outcomes and non-conformances
• Corrective and preventive action (CAPA) processes
• Document control and revision management
• Traceability and batch/serial control
• Supplier approval and incoming inspection
• Training and competency records

A well-implemented management system can support stronger insurance terms by demonstrating that failures are less likely to escalate into major losses.

Aerospace & Defence Compliance: Insurance Implications

Aerospace and defence supply chains are among the most demanding from an insurance standpoint. Components are often safety-critical, have long service lives, and operate in extreme environments. Insurers underwriting aerospace risks focus heavily on process discipline and traceability.

Key insurance considerations include:

• Higher product liability limits due to potential claim severity
• Long tail exposure (claims arising many years after supply)
• Strict change control and deviation approval requirements
• Export controls and jurisdiction considerations
• Contractual liability clauses that may exceed standard cover

Aerospace-certified businesses are often viewed more favourably by insurers, but only if certification is actively maintained and reflected in day-to-day operations.

Medical Device Manufacturing: High Scrutiny, High Stakes

Medical device and life-science manufacturing presents unique insurance challenges. Even minor defects can have serious consequences, and regulatory expectations are high.

Insurers underwriting medical manufacturing risks typically focus on:

• ISO 13485 certification and scope
• Risk management files and design history files (DHF)
• Validation of processes (cleaning, sterilisation, assembly)
• Complaint handling and vigilance reporting
• Recall and field safety corrective action exposure

Medical manufacturing often requires tailored product liability limits and careful review of exclusions relating to recall, rectification and regulatory action.

ISO Standards & Core Insurance Lines

ISO certifications interact with multiple insurance policies:

• Product Liability – quality controls and traceability reduce defect escalation risk
• Professional Indemnity – documented design and change control supports defence
• Employers’ Liability – ISO 45001 supports health & safety management
• Environmental Liability – ISO 14001 supports pollution risk management
• Property & BI – maintenance and housekeeping reduce loss frequency

While insurers won’t replace risk management with insurance, strong compliance can help remove exclusions, reduce uncertainty and improve underwriting confidence.