Enterprise Security

Compliance & Monitoring: ISO Standards

In high-stakes engineering, quality is a verifiable state of compliance. Edelweis aligns every design decision, simulation, and output with international benchmarks such as ISO 9001:2015 and ISO 13485, ensuring products are audit-ready through baked-in Audit Logs and V&V Protocols.

1. ISO-Aligned Quality Management (QMS)

We integrate international standard principles directly into our PDM Vault to automate compliance:

Document Control

ISO 9001:7.5 compliance; every technical document undergoes formal "Review and Approve" cycles with e-signatures.

Design Planning

Formal Project Charters mapping inputs (user requirements) to outputs (Unified TDP) via strict ECO management.

Data Traceability

ISO 9001:8.5.2 "Golden Thread" linking physical parts to material certs and inspection data in QC checklists.

2. Continuous Monitoring & Technical Audits

Monitoring Gate	Technical Protocol	ISO Reference
Internal Peer Audit	Reviewer audits Lead Engineer simulation.	Evaluation of Design Outputs.
Supplier Monitoring	Evaluating Vendor Communication and quality.	Control of External Processes.
Non-Conformance	Formal logging of parts failing QC Checklists.	Control of Nonconforming Outputs.
Risk Management	Performing FMEA within Prototyping Protocols.	Actions for Risks & Opportunities.

3. Regulatory Data Sovereignty

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Infrastructure Isolation: Using Private Servers and VPNs to ensure sensitive data never touches the public internet (ISO 27001).
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Identity Governance: SSO Integration and MFA ensure only authorized roles modify "Released" engineering data.
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Immutable History: Audit Logs provide the unalterable Design History File (DHF) required for regulatory submissions.

4. Corrective & Preventive Actions (CAPA)

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Root Cause Analysis (RCA): Tracing Fatigue Testing failures back through Audit Logs to identify design or material flaws.
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Preventive Refinement: Using live CAD Review Sessions to implement CAPA measures globally across the assembly.
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Feedback Loop: Integrating client feedback from Handover Workflows into our internal "Lessons Learned" library.

Technical Directives

Directive	Protocol
Standard Operative Procedure	All engineering activities must follow the documented SOPs stored in the Cloud Collaboration Setup.
Measurement Traceability	All equipment used in QC Checklists must be calibrated to NIST-traceable standards.
Signature Authority	Only personnel assigned the Reviewer Role have authority to sign off on final compliance documents.