What to Expect

Initial Scoping

Prior to the audit, scope, objectives, applicable standards, regulatory frameworks, and any company- or customer-specific requirements are confirmed.

Audit logistics, language preferences, reporting requirements, and timelines are agreed in advance to ensure clarity for all parties.

Audit Planning

Audit planning includes pre-audit review of selected documentation to support understanding of the organization’s quality management system and operational context.

This review allows the audit to be appropriately scoped, risk-based, and efficient. Documentation requested is limited to what is necessary for audit planning — no consulting, readiness assessment, or remediation guidance is provided.

Audit Execution

Audits are conducted through interviews, review of objective evidence, and direct observation of activities — including on-site observation of manufacturing and production floor activities where applicable.

Audits may be performed in English, Spanish, or both. All audits are conducted professionally, respectfully, and with a focus on objective evidence.

Audit Reporting

Findings are clearly described, traceable to applicable requirements, and supported by objective evidence. Findings are classified using defined grading criteria for consistent severity determination.

Reports are structured for both internal use and external review by customers or regulators. Reports may be issued in English or Spanish.

Findings Review Optional Add-On

At the client’s request, review and formal closure of audit findings may be provided. This includes review of objective evidence, confirmation that evidence addresses findings, and formal documentation of closure.

No remediation development, implementation guidance, or consulting support is provided as part of this service.

Secure Audit Management

Audit documentation and final reports are provided through a secure client portal, supporting controlled access to audit records, historical documentation, and audit calendar tracking.