Instructions for use!

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Policy - The WHY

This document contains a policy. Policies explain why we do something — the guiding principles, goals, and intentions behind our actions. Policies are high-level rules set by leadership to ensure we meet legal, security, and organizational requirements.

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🔹 Version

• Current Version: 1.0

If you change the content of this document the version number must be updated and a Change-log entry must be added at the end of this document. Changes to spelling do not need to be documented.

🔹 Purpose

To ensure that all incidents, nonconformities, and other deviations from expected operation are identified, documented, analyzed, and responded to in a timely and consistent manner. This supports legal, regulatory, and contractual obligations, as well as continual improvement and risk reduction.

This policy supports the requirements of:

• ISO/IEC 27001:2022, Annex A.5.25–A.5.30 (Information security incident management)
• ISO 13485:2016, Clauses 8.2–8.5 (Monitoring, CAPA, improvement)
• GDPR, MDR, and national regulations where applicable

🔹 Scope

This policy applies to:

• All employees, contractors, and external parties acting on behalf of Lifeness
• All information security incidents, operational disruptions, and product or process nonconformities