Below are answers to commonly asked questions about our independent audit services. If you have additional questions, please get in touch — we are happy to discuss your specific needs.
General Questions
What types of audits do you provide?
We provide independent internal audits and supplier audits for organizations operating in highly regulated industries, including medical devices, diagnostics/IVD, and aerospace. Audits are conducted against applicable international standards, regulatory requirements, and company- or customer-specific criteria.
What standards and frameworks do you audit against?
Audits are conducted against applicable standards and regulatory frameworks, including ISO 13485, ISO 9001, and transitioning requirements such as FDA QMSR. Where applicable, audits also assess compliance with internal procedures and customer-specific requirements beyond baseline regulatory or certification requirements.
Do you provide consulting or implementation support?
No. We operate exclusively as an audit-only organization. We do not provide consulting, implementation, remediation, or advisory services. This boundary is fundamental to preserving audit independence and ensuring that our findings remain objective, unbiased, and free from conflicts of interest.
What is the difference between your audits and a certification body audit?
Certification body audits determine whether an organization meets the requirements for certification to a specific standard. Our audits are independent, OEM-grade assessments designed to evaluate system performance, compliance risk, and operational maturity — with the rigor and depth expected by regulators and major OEMs. We are not a certification body and do not issue certifications.
Engagement & Process
How does an engagement begin?
Engagements begin with a free initial consultation to understand your organization, industry, and audit needs. If aligned, we provide a free, no-obligation quote. Once agreed, the audit is formally scoped, planned, and scheduled.
How long does a typical audit take?
Audit duration depends on the scope, complexity, and size of the organization or supplier being audited. Duration is determined during the scoping phase and communicated clearly before the engagement begins.
Can audits be conducted remotely?
Yes. Audits may be conducted on-site, remotely, or through a hybrid approach, depending on organizational needs, audit objectives, and the nature of the processes being assessed.
What languages are audits available in?
Audit services are available in English and Spanish. Audits may be conducted in English, Spanish, or a combination of both. Audit reports can be issued in either language.
What happens after the audit?
After the audit, a formal audit report is issued with clearly described findings. An optional findings review and closure service is available as an add-on. No remediation guidance or implementation support is provided.
Reporting & Findings
How are audit findings classified?
Findings are classified using defined grading criteria to support consistent and objective determination of severity (e.g., minor or major). This supports clear communication and appropriate prioritization.
Are audit reports defensible during regulatory inspections?
Yes. Reports are structured to support defensibility during regulatory inspections, customer audits, and internal management review. Findings are clearly written, traceable to applicable requirements, and supported by documented observations.
How are audit records managed?
Audit documentation and final reports are provided through a secure client portal supporting controlled access to audit records, historical documentation, and audit calendar tracking.
Pricing & Scheduling
How much do audits cost?
Audit fees depend on the scope, complexity, location, and duration of the engagement. A free, no-obligation quote is provided following the initial consultation. There are no hidden fees.
How far in advance should I schedule an audit?
We recommend reaching out as early as possible, especially if you have a specific timeline driven by regulatory, customer, or internal requirements. We accommodate flexible scheduling where possible.
Is the initial consultation really free?
Yes. The initial consultation is completely free and carries no obligation. It is designed to understand your organization, industry, and audit needs, and to determine whether an engagement is appropriate.