Functional Safety Audit, Assessment & Certification Support Services
VerveTronics provides Functional Safety Audit, Assessment, Gap Analysis and Certification Support Services for safety-critical electrical, electronic, embedded and control systems. We help organizations assess the maturity and compliance of their Functional Safety processes, engineering work products, safety lifecycle and evidence against applicable standards including ISO 26262, IEC 61508 and ISO 13849.
Our support spans Functional Safety process audits, project milestone audits, safety work-product reviews, compliance and gap assessments, safety case and safety argument support, requirements traceability, corrective-action planning and assessment readiness. We work with engineering, quality, safety and program teams to identify gaps early and build the evidence needed for customer reviews, independent assessments and certification activities.
For organizations targeting automotive ASIL, industrial SIL or machinery Performance Level objectives, our approach connects process compliance with the technical evidence behind the product—safety requirements, architecture, HARA/FMEA/FMEDA/FTA/DFA, verification and validation, safety mechanisms, safety metrics and safety-case evidence.
Need support with an Functional Safety project? Contact our Functional Safety experts
- Audit findings discovered too late: Late discovery of missing safety plans, incomplete work products, weak traceability or process deviations can create expensive rework close to an assessment milestone.
- Process compliance without technical evidence: A documented process alone is not sufficient. Auditors and assessors need objective evidence that the defined process was followed and that safety engineering outputs are consistent.
- Inconsistent work products: HARA, safety goals, requirements, architecture, FMEA/FMEDA/FTA, verification and safety case documents can contain conflicting assumptions or terminology.
- Weak requirements traceability: Safety requirements need a defensible path from hazards/safety goals through implementation and verification evidence.
- Assessment independence and review expectations: Projects need to understand which reviews or confirmation measures should be performed with the required degree of independence under the applicable standard and project plan.
- Corrective actions without root-cause closure: Closing an audit observation requires more than changing a document. The underlying process, responsibility, evidence and recurrence controls may also need to be addressed.
- Certification body readiness: Organizations often need a structured readiness review before engaging an independent assessment or certification body.
Need support with an Functional Safety project? Contact our Functional Safety experts
Our audit and assessment-support approach is evidence-driven. The exact criteria are tailored to the applicable standard, product lifecycle, safety target, organizational process and assessment scope.
| Audit / Assessment Area | What We Review | Typical Evidence | Outcome |
| Functional Safety Management | Roles, responsibilities, safety planning, lifecycle tailoring, competence, independence, reviews and change management. | Safety plan, safety manual/process, responsibility matrix, review records, training/competence records. | Management/process findings and improvement actions. |
| Safety Lifecycle & Process | Defined lifecycle, gates, tailoring, work-product expectations and project adherence. | Process documents, project plans, lifecycle records, milestones, deviations. | Process compliance/gap assessment. |
| Hazard & Safety Analysis | HARA/risk analysis, safety goals/functions and assumptions; FMEA, FTA, FMEDA, DFA where applicable. | Analysis reports, assumptions, calculation models, review records. | Technical analysis findings and closure actions. |
| Requirements & Traceability | Safety goals, functional/technical safety requirements, allocation, bidirectional traceability and change control. | Requirements database, trace matrix, review/approval evidence. | Traceability gaps and remediation plan. |
| Architecture & Safety Mechanisms | Safety architecture, redundancy, diagnostics, fault reaction, independence and safety mechanisms. | Architecture documents, safety mechanism specifications, design records. | Architecture/evidence observations. |
| Verification & Validation | Verification planning, coverage, test results, fault injection, safety mechanism verification and validation evidence. | Test plans/results, review reports, fault-injection evidence. | V&V evidence gaps and readiness actions. |
| Safety Case & Compliance | Safety argument structure, claims, assumptions, evidence and compliance matrix. | Safety case, safety argument, compliance matrix, evidence index. | Assessment-ready evidence structure. |
Need support with an Functional Safety project? Contact our Functional Safety experts
- Functional Safety Process Audit — Audit the organization’s or project’s Functional Safety lifecycle, processes, roles, work products, reviews, tailoring, independence and evidence against the applicable safety standard.
- Functional Safety Gap Assessment — Identify gaps between the current development process/product evidence and applicable ISO 26262, IEC 61508 or ISO 13849 expectations; prioritize actions by project milestone and safety impact.
- ISO 26262 Safety Audit & Assessment Support — Support automotive programs with process and technical evidence reviews covering concept, system, hardware, software, supporting processes, safety analyses, verification/validation and safety case activities as applicable.
- IEC 61508 SIL Assessment & Certification Support — Support industrial safety projects with lifecycle/process reviews, SIL-oriented evidence review, safety analysis, hardware/software evidence, safety case preparation and assessment readiness.
- ISO 13849 Safety Assessment Support — Review machinery safety functions, risk reduction, safety-related control architecture and applicable PL-related evidence, including MTTFd, DCavg and CCF considerations where applicable.
- Safety Work-Product Review — Independent or peer review of safety plans, HARA, FMEA, FMEDA, FTA, DFA, safety concepts, requirements, architecture, verification and validation work products.
- Safety Case & Safety Argument Support — Define claims, arguments, assumptions and evidence structure; organize the compliance matrix and evidence index needed to demonstrate achievement of safety objectives.
- Assessment Readiness Review — Perform a pre-assessment review to identify open findings, evidence gaps, traceability issues and likely assessment questions before the formal assessment.
- Corrective Action & Finding Closure — Analyze audit/assessment findings, identify root causes, define corrective actions and support evidence-based closure.
- Customer / Supplier Safety Audit Support — Support OEMs, Tier-1s and technology suppliers in assessing supplier safety processes, project evidence, safety deliverables and compliance status.
- Safety Process Improvement & Training — Improve organizational Functional Safety processes, templates and workflows and train engineering, quality, project and safety teams on practical implementation.
Typical Audit / Assessment Deliverables
- Audit / assessment plan and scope
- Applicable standard and requirement checklist
- Process and technical evidence review
- Gap / finding register with severity or priority classification as agreed
- Compliance matrix and traceability review
- Safety work-product review reports
- Assessment-readiness report
- Corrective-action and closure tracker
- Safety case / safety argument structure and evidence index
- Management summary with key risks, open actions and milestone recommendations
- Re-assessment / closure review support
Standards & Frameworks
- ISO 26262 — Automotive Functional Safety and ASIL-oriented development.
- IEC 61508 — Functional Safety of electrical/electronic/programmable electronic safety-related systems and SIL-oriented lifecycle activities.
- ISO 13849 — Safety-related parts of control systems for machinery and Performance Level-oriented evidence.
- ISO 25119 — Functional Safety for tractors and machinery where applicable.
- DO-178, DO-254— DAL A – E, Complex electronic hardware design assurance, gate-level/FPGA verification.
- EN 50129 / EN 50126 / EN 50129 : Safety case assurance, hardware fault tolerance, reliability
- IEC 62304 (Software) + ISO 14971 (Risk): Hardware-software risk integration, fault control measures, Class A – C
- Related domain standards can be included in the audit/assessment scope where appropriate to the product and project.
Need support with an Functional Safety project? Contact our Functional Safety experts
The current VerveTronics page documents the following project experience. The copy below preserves those documented themes and presents them as credibility evidence rather than claiming that VerveTronics is the independent certification body.
- ASIL-D / SIL3 Electric Power Steering System – European Tier-1
- End-to-end ISO 26262 / IEC 61508 concept-to-certification support for a premium passenger-car application. VerveTronics’ documented role included safety/technical concepts and specifications, HARA, hardware FMEDA, software and mechanical FMEA, safety-compliant hardware/software specifications, assessment support and ASIL-D/SIL3 process development and improvement.
- ASIL-B DC Power Converter System – European Tier-1
- Support for development of a DC Power Converter System according to ASIL-B, including safety/technical concepts and specifications, hardware FMEDA, software and mechanical FMEA, safety-compliant specifications and safety assessment.
- ASIL-C Electronics DC Protection System – US Tier-1
- End-to-end ISO 26262 ASIL-C compliance support, including safety/technical concepts, hardware FMEDA, software/mechanical FMEA, safety-compliant specifications, ASIL-C/ASPICE process development and improvement, and safety assessment.
Need support with an Functional Safety project? Contact our Functional Safety experts
- Automotive & EV — ISO 26262 programs covering electrification, BMS, power electronics, DC/DC converters, steering, braking, powertrain, ADAS, body/domain/zonal controllers and other E/E systems.
- Industrial — IEC 61508 lifecycle, process and safety assessment support for PLCs, safety PLCs, drives, industrial automation, process control, power electronics and machine control.
- Machinery & Robotics — ISO 13849 / ISO 10218-oriented safety functions, risk reduction, safety-related control systems, PL-oriented evidence and assessment preparation.
- Off-Highway & Agricultural — safety lifecycle and assessment support for mobile machinery and tractor-related applications where applicable.
- Battery & Energy Storage — safety process and assessment support for BMS, battery electronics and energy-storage control systems.
- Semiconductor & Embedded Systems — safety process, architecture, analysis and evidence reviews for safety-related semiconductor and embedded platforms.
- Aerospace & Defence — safety-process and assurance support can be aligned to the applicable aerospace/defence development and assurance framework when within project scope.
- Railway & Medical — assessment/process support can be tailored to applicable railway or medical safety standards where required.
Need support with an Functional Safety project? Contact our Functional Safety experts
- Pre-Assessment / Readiness Review — Fixed-scope review before an independent assessment, customer audit or certification milestone.
- Functional Safety Process Audit — Milestone-based audit of the organization’s or project’s safety process and evidence.
- Independent Work-Product Review — Focused review of selected safety work products such as HARA, safety requirements, architecture, FMEDA, safety case or V&V evidence.
- Gap Assessment & Remediation — Gap identification followed by a practical closure roadmap and support for corrective actions.
- Dedicated Safety Assessment Support Team — Embedded safety experts working with engineering, quality and program teams through a defined milestone or assessment.
- Managed Compliance & Certification Support — Longer-term support covering planning, evidence management, assessment coordination and closure activities.
- Training & Audit Preparation Workshop — Targeted workshops for engineering and management teams before internal/customer/independent audits.
Need support with an Functional Safety project? Contact our Functional Safety experts
- What is a Functional Safety Audit? – A Functional Safety Audit is a structured review of defined safety processes, project activities, work products and objective evidence against applicable requirements. It can be performed at organizational, project or milestone level.
- What is a Functional Safety Assessment? – A Functional Safety Assessment evaluates whether a product/project has achieved its applicable safety objectives and whether the supporting development processes and evidence are adequate for the defined assessment scope. The exact assessment method and independence requirements depend on the applicable standard and project.
- What is the difference between an audit and an assessment? – An audit generally focuses on conformity of defined processes and evidence against specified criteria. An assessment is broader and can evaluate whether the safety objectives have been achieved using the required processes, engineering evidence and safety argument.
- Does VerveTronics provide Functional Safety certification? – VerveTronics provides consulting, engineering, audit support, assessment preparation and certification support. Where formal certification or independent assessment is required, the independent accredited/authorized assessment or certification organization performs that activity.
- Can VerveTronics prepare us for a TÜV/UL or other independent assessment? – Yes, VerveTronics can support assessment readiness by reviewing processes and work products, identifying gaps, organizing evidence, improving traceability and supporting corrective-action closure. The formal assessment remains with the applicable independent organization.
- What does an ISO 26262 audit review? – Depending on scope, an ISO 26262 audit can review the safety lifecycle, management, planning, confirmation measures, work products, requirements traceability, safety analyses, architecture, hardware/software development, verification/validation and safety case evidence.
- What does an IEC 61508 assessment review? – Depending on scope, it can review the safety lifecycle, management, hazard/risk analysis, SIL-related requirements, architecture, hardware/software safety evidence, verification/validation, safety case and supporting objective evidence.
- What does an ISO 13849 assessment review? – Depending on scope, it can review safety functions, risk reduction, safety-related control architecture and applicable Performance Level evidence, including relevant MTTFd, diagnostic coverage and common-cause-failure considerations.
- Can you perform a gap assessment before we start development? – Yes. A process gap assessment can be performed early to establish the required lifecycle, roles, work products, templates, reviews and evidence before product development milestones begin.
- Can you audit an existing project that is already in development? – Yes. A milestone-based audit can review the current state, identify missing or inconsistent evidence and establish a prioritized closure plan.
- Can you review our safety case? – Yes. Safety-case support can include claims, arguments, assumptions, evidence mapping, compliance matrix and traceability review.
- Can you support closure of audit findings? – Yes. Support can include root-cause analysis, corrective-action definition, work-product updates, evidence generation and closure review.
- What information is needed to start an audit or assessment? – Typical inputs include the applicable standard, product/system scope, safety target, safety plan, lifecycle/process documentation, project status, key work products, requirements and architecture information, analysis outputs, V&V evidence and any previous audit/assessment findings.
- How early should we perform a Functional Safety readiness review? – Ideally before major assessment milestones, but a readiness review can be useful at any project stage. Earlier reviews generally provide more opportunity to address process and evidence gaps before they create schedule pressure.
- Preparing for a Functional Safety Audit or Assessment?
- Let our Functional Safety experts review your current process, project evidence and assessment scope. We can identify gaps, prioritize corrective actions and help prepare the technical evidence and safety case needed for your next milestone, customer review or independent assessment.
- Request a Functional Safety Audit / Assessment
- Get a Functional Safety Gap Assessment
- Prepare for ISO 26262 / IEC 61508 / ISO 13849 Assessment
- Talk to a Functional Safety Assessment Expert
Need support with an Functional Safety project? Contact our Functional Safety experts