Auditing
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Gap Analysis / Pre-Assessment Audits
We provide comprehensive gap analysis and pre-assessment audit services to evaluate your organization’s readiness for certification or compliance with industry standards such as ISO 9001, AS9100, or ISO 13485. Our certified, experienced auditors assess your current processes, documentation, and implementation practices against applicable requirements to identify nonconformities, systemic weaknesses, and improvement opportunities. This structured evaluation delivers clear, prioritized findings that allow you to address gaps proactively before undergoing a formal certification audit. Whether implementing a new management system or strengthening an existing one, our pre-assessment services help reduce risk, increase confidence, and support a smoother path to successful compliance.
Internal Audits
Utilizing its certified lead auditors, we will plan and conduct internal audits to verify the degree of conformance of activities performed under the client’s Business Management System (BMS) / Quality Management System (QMS) to the applicable standards, such as ISO 9001, ISO 13485, ISO 14001, or AS9100.
Our audits go beyond compliance checks. They provide an objective, independent assessment of how well the system is implemented and functioning. We evaluate the effectiveness of documented processes, the consistency of their execution, and the organization’s ability to meet internal objectives and external requirements. We help identify nonconformities, systemic issues, and improvement opportunities, enabling leadership to make informed supply chain decisions regarding supplier qualification, continued approval, risk mitigation, and overall sourcing strategies.
Our approach is risk-based, process-focused, and tailored to the maturity and complexity of the client’s operations.
Process Audits
Our process audits evaluate the effectiveness, consistency, and compliance of operational and quality-critical processes. We assess whether processes are being executed as planned, are aligned with business objectives, and are capable of delivering intended results.
Using industry best practices and applicable standards, we examine process inputs, controls, outputs, interfaces, and risks. Our audits help identify inefficiencies, gaps in execution, and opportunities for improvement in manufacturing, engineering, quality, and support functions. This ensures a strong foundation for continual improvement and operational excellence.
We take a practical, in-depth approach to process audits. Our goal is to help you understand how your operations are performing, not just on paper, but in real time. We look at how well processes are defined, executed, and controlled, identifying areas where they can be simplified, aligned, or strengthened. Whether you are in aerospace manufacturing, medical device production, or a complex service environment, we tailor each audit to the standards you follow and the challenges you face.
Product Audits
Product audits go beyond inspecting finished goods, they are about protecting your reputation and ensuring that what leaves your facility meets every requirement it’s supposed to. We audit product characteristics, documentation, and traceability to make sure what was designed, built, and delivered is exactly what your customer expects. These audits are especially critical in industries where the margin for error is zero.
We perform product audits to confirm that manufactured items, components, or assemblies meet customer, regulatory, and design requirements. These audits focus on verifying product characteristics, documentation, labeling, traceability, and compliance with technical specifications.
Our team supports organizations in high-reliability industries, including aerospace, defense, and medical devices, by identifying quality issues before products reach the customer. Product audits also play a vital role in root cause analysis, corrective action validation, and continual improvement within the production and quality assurance environments.
Supplier Audits
A strong supply chain is not just an extension of your business but a foundational element of operational success. We help you assess whether your suppliers have the systems, controls, and capabilities to meet your requirements, consistently and reliably. From initial qualification to ongoing surveillance, we look at management systems, process maturity, delivery history, and risk factors. Our work helps you build confidence in your supply base and make informed sourcing decisions.
Our supplier audits assess the capability, compliance, and performance of vendors, subcontractors, and external service providers. Whether for supplier qualification, surveillance, or development, we provide comprehensive evaluations based on applicable industry standards.
We examine key areas including quality management systems, process controls, traceability, risk management, regulatory compliance, and delivery performance. Our audits help organizations strengthen their supply base, ensure compliance with customer, contractual, and regulatory requirements, and drive accountability throughout the supply chain.
Configuration Audits
In highly regulated and technical environments, configuration control is non-negotiable. We perform configuration audits to ensure that what’s documented matches what’s built, and that all changes are properly reviewed, approved, and traceable. Whether it's a critical aerospace component or a regulated medical device, we help you maintain control over the configuration baseline and reduce risk in design and production.
We conduct configuration audits to verify that products and systems conform to their defined configuration documentation and that all required records, changes, and approvals are properly maintained and controlled throughout the product lifecycle.
We perform both Functional Configuration Audits (FCA) and Physical Configuration Audits (PCA) to ensure that design requirements are accurately reflected in the final product and that all supporting documentation is complete, current, and compliant with applicable standards.
Our audits focus on areas such as:
- Configuration item identification and control;
- Change management and traceability;
- Document and data integrity;
- Compliance with the applicable standard (e.g., AS9100, ISO 13485) and customer-specific requirements.
Configuration audits are critical in high-reliability industries like aerospace and medical devices, where traceability, regulatory compliance, and product integrity are essential. We help clients ensure alignment between engineering, manufacturing, and quality, reducing risk and supporting robust product realization processes.
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