Certification & Audit
"Confirm Functional Safety Compliance" Through Independent Verification
We perform ISO 26262 Confirmation Measures (Review, Audit, Assessment).
Assessors with independence and expertise verify your functional safety activities.
We perform ISO 26262 Confirmation Measures (Review, Audit, Assessment). Assessors with independence and expertise verify your functional safety activities.
Why You Need This
Functional Safety Assessment
- Is This Your Situation?
Do you need independent Confirmation Measures as required by ISO 26262?
Depending on ASIL level, independent Review, Audit, and Assessment are required. Verification by external experts independent from the development organization is necessary.
Are you concerned about your readiness for upcoming OEM or certification body functional safety assessments?
Before the main assessment, you need to pre-check the adequacy of current functional safety activities and address weaknesses.
Do you need assessors with deep understanding of ISO 26262?
Functional safety assessment requires deep standard understanding and practical experience to receive meaningful feedback.
Service Introduction
SeonENS Functional Safety Assessment Service
At SeonENS, ISO 26262 experts perform independent Confirmation Measures.
Review, Audit, and Assessment procedures comply with ISO 26262 standards, guaranteeing independence and expertise.
Independence Secured
Experts independent from the development organization conduct assessments. We meet the independence levels required by ISO 26262.
Standards-Compliant Procedures
Review, Audit, and Assessment procedures are performed according to ISO 26262 Part 2 and Part 8.
Practical Feedback
We provide specific feedback for improvement, not just pass/fail determinations.
OEM Response Support
We provide pre-assessment checks and response support before OEM assessments.
Assessment Types
Confirmation Review
Purpose
Confirm technical accuracy of work products
ASIL Requirements
| ASIL | Independence Requirement |
|---|---|
| ASIL A | I1 (Different person) |
| ASIL B | I1 (Different person) |
| ASIL C | I2 (Different team/department) |
| ASIL D | I2 or I3 (Different organization) |
Review Subject Examples
- Safety requirements specifications
- Safety analysis results (FMEA, FTA)
- Safety concepts
- Design and verification work products
Deliverables
- Review Report
- Finding list and recommendations
- Approval/Conditional approval/Rejection determination
Confirmation Audit
Purpose
Confirm process compliance
Audit Subjects
- Functional safety process compliance
- Work product consistency
- Traceability confirmation
- Configuration/Change management adequacy
Audit Approach
- Process document review
- Project work product sampling verification
- Responsible personnel interviews
Deliverables
- Audit Report
- Nonconformity list
- Improvement recommendations
Functional Safety Assessment
(FSA)
Purpose
Comprehensive evaluation of entire functional safety activities
Assessment Scope
- Item Definition
- HARA and Safety Goals
- Functional Safety Concept
- Technical Safety Concept
- System/HW/SW design and verification
- Safety Case
Assessment Criteria
- ISO 26262 Part 2~11 requirements fulfillment
- Evidence adequacy for Safety Goal achievement
- Confirmation Measure performance adequacy
Deliverables
- FSA Report
- Compliance determination (Positive/Negative Recommendation)
- Items requiring improvement
FSA Process
Phase 1: Assessment Planning
- Confirm assessment scope and subjects
- Define assessment criteria and methods
- Coordinate assessment schedule
- Deliver required document list
Phase 2: Document Review
- Pre-submitted document review
- Prepare assessment checklist
- Request additional materials
- Prepare interview questions
Phase 3: On-site Assessment
- Opening Meeting
- Document assessment and interviews
- Daily Wrap-up
- Closing Meeting (share preliminary results)
Phase 4: Report Writing
- Compile assessment results
- Write FSA Report
- Final determination and recommendations
ASIL-based Confirmation Measure Requirements
| Activity | ASIL A | ASIL B | ASIL C | ASIL D |
|---|---|---|---|---|
| Safety Plan Review | I1 | I1 | I2 | I2 |
| HARA Review | I1 | I1 | I2 | I2 |
| FSC Review | I1 | I2 | I2 | I3 |
| TSC Review | I1 | I2 | I2 | I2 |
| System Design Review | I1 | I2 | I2 | I3 |
| SW Design Review | I1 | I2 | I2 | I3 |
| HW Design Review | I1 | I2 | I2 | I3 |
| Safety Audit | - | I1 | I2 | I2 |
| FSA | I1 | I1 | I2 | I2 |
Independence Levels
- I1: Different person (same team possible)
- I2: Different team, department, or organization
- I3: Different organization (external body)
Expected Benefits
Practical Benefits
- Reliability Through Independent Verification
- Objective verification by external experts not involved in development. Assessment is the process of confirming "Is this a safe product?" - and that answer must be genuine to be meaningful.
- Early Detection of Omissions and Errors
- Independent perspective discovers what the development team missed. Problems found in assessment are far better than problems found after production.
- Specific Feedback for Improvement
- Not just pass/fail determinations, but explanations of "why it's non-compliant" and "how it can be improved."
- Deepened Functional Safety Understanding
- Through the assessment process, participants understand the intent of ISO 26262. When you understand why these Confirmation Measures are needed, they naturally apply in the next project.
Functional Safety Assessment - Work with Experts
Functional Safety Assessment
- Work with Experts
ISO 26262 experts independently verify your functional safety activities.
Tell us your ASIL level and assessment scope, and we’ll propose the optimal assessment plan.
ISO 26262 experts independently verify your functional safety activities. Tell us your ASIL level and assessment scope, and we’ll propose the optimal assessment plan.