Incident and Non-Conformance Management Policy Template for Switzerland

An Incident and Non-Conformance Management Policy helps Swiss organizations track, handle, and learn from unexpected events and compliance gaps. It sets clear steps for reporting issues, investigating root causes, and taking corrective actions - all while meeting strict Swiss regulatory requirements, especially in sectors like manufacturing, healthcare, and financial services.

The policy ensures companies document and address both safety incidents and quality deviations systematically. It aligns with Swiss quality standards and workplace safety laws, creating a framework for continuous improvement. Teams use this policy daily to prevent problems from recurring, protect workers, and maintain high operational standards that Swiss businesses are known for.

Implement an Incident and Non-Conformance Management Policy when your Swiss organization needs to systematically handle workplace accidents, quality deviations, or compliance breaches. This becomes essential during quality certifications, after serious incidents, or when expanding into regulated industries like pharmaceuticals, medical devices, or financial services.

The policy proves particularly valuable when facing regulatory inspections, managing multiple facilities, or coordinating response teams across departments. It helps Swiss companies meet SUVA workplace safety requirements, maintain ISO certifications, and protect against liability. Having this system ready before incidents occur ensures swift, consistent responses and demonstrates proper governance to authorities.

• Basic Quality Management: Focuses on product defects and process deviations, commonly used in Swiss manufacturing and food production sectors
• Health and Safety Focused: Emphasizes workplace accidents and near-misses, aligned with SUVA requirements and Swiss occupational safety laws
• GMP Compliance: Detailed version for pharmaceutical and medical device companies meeting Swissmedic regulations
• Environmental Incident: Centers on environmental impacts and regulatory reporting under Swiss environmental protection laws
• Financial Services: Tailored for banks and insurers, addressing operational incidents under FINMA guidelines

• Quality Managers: Lead the development and maintenance of the policy, ensuring it meets ISO standards and Swiss regulatory requirements
• Department Heads: Implement procedures, train staff, and oversee incident reporting within their areas
• HSE Officers: Monitor workplace safety incidents and coordinate with SUVA requirements
• Compliance Teams: Ensure alignment with Swiss regulations and industry standards
• Front-line Workers: Report incidents and follow corrective action procedures
• External Auditors: Review policy effectiveness during certification audits and regulatory inspections

• Industry Requirements: Review specific Swiss regulations for your sector (SUVA, Swissmedic, FINMA)
• Current Processes: Map existing incident reporting and handling procedures across departments
• Risk Assessment: Document common incidents and non-conformances specific to your operations
• Stakeholder Input: Gather feedback from quality, safety, and department managers
• Response Templates: Create standardized forms for incident reporting and investigation
• Training Plan: Develop staff training materials on policy implementation
• Review Cycle: Establish timeframes for policy updates and effectiveness reviews

• Purpose Statement: Clear objectives aligned with Swiss quality and safety regulations
• Scope Definition: Specific incidents and non-conformances covered under Swiss law
• Reporting Procedures: Detailed process for documenting and escalating incidents
• Investigation Protocol: Structured approach for root cause analysis and evidence gathering
• Corrective Actions: Framework for implementing and tracking improvement measures
• Data Protection: Compliance with Swiss data privacy requirements for incident records
• Review Process: Regular evaluation and update procedures
• Roles Matrix: Clear assignment of responsibilities and authority levels

The Incident and Non-Conformance Management Policy differs significantly from a Risk Management Policy in both scope and application. While both documents support organizational compliance, they serve distinct purposes in the Swiss regulatory landscape.

• Focus and Timing: The Incident Policy deals with actual events and deviations after they occur, while the Risk Management Policy works proactively to identify and prevent potential issues
• Implementation Scope: Incident policies provide specific procedures for handling and documenting individual occurrences, whereas risk management covers broader strategic planning and mitigation strategies
• Regulatory Requirements: Incident policies must align with immediate reporting obligations under Swiss law, while risk management policies address longer-term compliance planning
• Stakeholder Involvement: Incident policies primarily engage operational staff and immediate response teams, while risk management involves leadership and strategic planning teams