Independent, OEM-Grade Audits for Highly Regulated Industries
Audit-only services supporting compliance, risk control, and operational integrity across regulated environments — including medical devices, diagnostics, and aerospace.
Request a Free ConsultationPreserving the Integrity of the Audit Process
We operate exclusively as an audit-only organization, delivering rigorous, unbiased audits aligned with real-world regulatory and customer expectations — without consulting, implementation, or conflicts of interest.
Our ApproachInternal & Supplier Audits You Can Defend
Risk-based, process-focused audits conducted against ISO 13485, ISO 9001, FDA QMSR, and customer-specific requirements. Findings are clear, traceable, and supported by objective evidence.
What to Expect
Internal Audits
Independent audits against ISO 13485, ISO 9001, and FDA QMSR frameworks.
Supplier Audits
OEM-style supplier audits for qualification, monitoring, and risk management.
Secure Audit Management
Audit documentation and reports delivered through a secure client portal.
Independent Audit Services
OEM-Grade Audits for Regulated Industries
We provide independent, audit-only services for organizations of all sizes operating in highly regulated environments, including medical devices, diagnostics, and aerospace.
Our internal and supplier audits are conducted with the same rigor, objectivity, and risk-based focus expected by regulators and major OEMs — without consulting, implementation, or conflicts of interest.
Our purpose is to uphold the integrity of the audit process by delivering independent, OEM-grade audits for highly regulated organizations and their critical suppliers.
By operating exclusively as an audit-only organization, we preserve objectivity and deliver clear, defensible insight into system performance, compliance risk, and operational maturity.
What We Do
Audit Services
Internal Audits
Independent internal audits performed against applicable standards and regulatory frameworks, including ISO 13485, ISO 9001, and transitioning requirements such as FDA QMSR. All audits are risk-based, process-focused, and conducted without consulting or implementation support.
Supplier Audits
OEM-style supplier audits supporting qualification, monitoring, and risk management of critical and high-impact suppliers. Performed against applicable regulatory requirements, quality standards, and customer-defined supplier criteria with defensible reporting.
Audit Planning & Execution
Internal and supplier audits may be conducted as single engagements or as part of a planned audit schedule aligned with organizational risk, supplier criticality, and regulatory expectations.
Risk-Based Methodology
Audits follow processes end-to-end, evaluate interfaces between functions, and assess how controls are implemented and maintained in practice — providing a realistic view of system performance.
Defensible Reporting
Findings are clearly written, traceable to applicable requirements, and supported by documented observations. Reports support defensibility during regulatory inspections and customer audits.
Secure Client Portal
Audit documentation and final reports provided through a secure client portal, supporting document control, audit history, and audit calendar tracking.
Why Choose Qualyx Group
Our Commitment
100% Audit Independence
We operate exclusively as an audit-only organization — no consulting, implementation, or remediation services. Zero conflicts of interest.
OEM-Grade Rigor
Audits conducted with the same methodology and expectations applied by major OEMs and regulatory bodies.
Regulatory Alignment
ISO 13485, ISO 9001, FDA QMSR, and customer-specific requirements — all under one audit engagement.
Bilingual Capability
Audits conducted in English, Spanish, or both. Reports issued in either language as agreed during scoping.