Independent Lead Auditing, Gap Assessments, and Regulatory Compliance Consulting across ISO, Aerospace, Medical Device, and Electronics Supply Chains.
With years of cross-disciplinary industrial experience spanning high-reliability electronics, precision aerospace components, and regulated medical manufacturing, our practice brings an uncompromising focus on objective evidence, standards conformity, and continual operational improvement.
We operate with strict adherence to ISO 19011 auditing principles, ensuring confidentiality, independence, and thorough risk-based evaluations. Whether conducting pre-certification gap assessments, fulfilling mandated annual internal audit cycles, or evaluating critical tier-1 suppliers, our assessments deliver actionable clarity without unnecessary theoretical bureaucracy.
Formal credentials certified by international standard-setting organizations. All qualifications are maintained through rigorous ongoing professional development and audit logs.
Quality Management Systems: Context evaluation, risk-based thinking, operational control, and supplier performance oversight.
Environmental Management Systems: Aspect/impact register review, legal compliance verification, and life cycle perspective.
Occupational Health & Safety: Hazard identification and risk evaluation (HIRADC), legal registers, incident reporting controls.
Business Continuity Management Systems: Business Impact Analysis (BIA), recovery strategy drills, continuity governance.
Aviation, Space & Defense: Counterfeit parts mitigation, FOD prevention, configuration management, and FAI evaluation.
Medical Device Quality Systems: Regulatory alignment, ISO 14971 risk management files, cleanroom controls, DHF & DMR.
Responsible Business Alliance: Labor rights, freely chosen employment, working hours compliance, health, and ethics audits.
Acceptability of Electronic Assemblies: Workmanship standards, solder criteria, component mounting Class 1/2/3 inspection.
Certified Manager of Quality / Organizational Excellence: Strategic deployment, process governance, and customer-focus metrics.
Certified Quality Auditor & Certified Quality Engineer: Statistical methods, metrology, hypothesis testing, sampling plans.
DMAIC project leadership, Cpk/Ppk process capability studies, 8D corrective actions, and measurement systems analysis (MSA).
Certified Environmental Professional in Scheduled Waste Management: Competent Person oversight under DOE Environmental Quality Regulations.
Scheduled waste code identification, consignment note reconciliation, inventory tracking, and electronic filing verification.
Secondary containment inspection, labeling compliance, incompatible waste segregation, and emergency response readiness.
| Standard / Designation | Governing Body | Credential Type | Primary Application | Engagement Availability |
|---|---|---|---|---|
| ISO 9001:2015 | IRCA / CQI | Lead Auditor | Enterprise Quality Management Systems | Available |
| ISO 14001:2015 | IRCA / CQI | Lead Auditor | Environmental Management & Legal Compliance | Available |
| ISO 45001:2018 | IRCA / CQI | Lead Auditor | Workplace Safety & HIRADC Protocols | Available |
| ISO 22301:2019 | IRCA / CQI | Lead Auditor | Business Continuity & Operational Resilience | Available |
| AS 9100 Rev D | IAQG / OASIS | Auditor | Aerospace & Defense Quality Systems | Available |
| ISO 13485:2016 | ISO / Medical | Auditor | Medical Device Design & Manufacturing QMS | Available |
| RBA VAP | RBA | VAP Auditor | Labor, Ethics, Health & Safety Verification | Available |
| CePSWaM | EiMAS / DOE | Certified Person | Scheduled Waste Compliance & eSWIS Tracking | Available |
Engagements designed for industrial manufacturing firms seeking independent objectivity, readiness verification, or regulatory compliance support.
Comprehensive outsourced internal audits fulfilling annual mandatory ISO clauses. Objective 2nd-party supplier evaluations, critical vendor qualification, and mock certification audits with detailed non-conformance logs.
Detailed clause-by-clause delta evaluation against target standards (e.g., transitioning to ISO 22301:2019, AS 9100 Rev D, or ISO 13485:2016). Pinpoints documentation and operational shortfalls prior to registrar audits.
Social responsibility and labor standard assessments aligned with the Responsible Business Alliance (RBA) Code of Conduct. Review of working hours, wage records, emergency preparedness, and worker health & safety.
Competent person consulting for DOE Scheduled Waste Management (EiMAS CePSWaM). Storage facility review, bunded containment checks, eSWIS consignment reporting, and environmental legal registers.
Internal auditor training workshops based on ISO 19011. Practical training on writing effective non-conformance reports, root-cause 8D problem solving, HIRADC safety risk assessment, and IPC-A-610 inspection basics.
Statistical process control (SPC), Cpk capability diagnostics, FMEA reviews, and Lean Six Sigma Green Belt (SSGB) DMAIC implementation to eliminate recurrent defects and optimize production yields.
A disciplined, 4-step linear protocol aligned with ISO 19011 to guarantee clear scope definition, rigorous evidence collection, and traceable closure.
Initial consultation, audit plan finalization, clause boundaries, and off-site preliminary documentation and manual review.
Opening meeting, personnel interviews, objective evidence sampling, physical facility walk-through, and daily debriefings.
Submission of formal audit findings, classified non-conformances (Major/Minor), opportunities for improvement (OFI), and CAP guidelines.
Review of corrective actions, root cause validation (5-Why/8D), corrective evidence confirmation, and final readiness endorsement.
Clarifications regarding audit modalities, independence boundaries, lead times, and regulatory scope.
Please submit your organizational details, target standards, and planned audit schedule. We evaluate each inquiry confidentially and reply within 1 business day with scoping requirements.