When a U.S. customer, retailer or certification body sets quality requirements for your U.S. warehouse, plant or subsidiary, our team works on site in Southern California, and at other U.S. sites by arrangement, to close the gaps and prepare for the audit, in Chinese with your management and in English with auditors and customers. In China, our Shenzhen team supports your factory.
Common situations
Requirements reach your U.S. operations as well as your factory abroad. The earlier the work starts, the less it costs.
In the U.S.
We work on site with your team, from the first gap assessment or review of audit findings to closure after the audit. Our founder leads the work in Southern California and at other U.S. sites by arrangement, with native Chinese speakers on the team.
We start from what your customer or auditor actually requires: the supplier requirements, the audit protocol or standard, and any prior findings. Each requirement and finding is mapped to evidence, an owner and a due date, and the corrective actions are scheduled against the audit date.
The quality manual and the procedures your requirements call for, such as GMP, ISO 9001 or ISO 13485, with controlled forms and records, document and change control, job descriptions, training and competency records, and record retention.
Follow-through on the floor: receiving, inspection, storage and shipping, lot traceability, FIFO/FEFO, nonconforming and returned product, cleaning, pest control and maintenance, plus training for your employees.
Internal audit and mock audit against the actual requirements, interview preparation, evidence package review, on-site support during the customer or certification audit when available, and corrective action follow-through until every finding is closed.
After the audit, we keep the system running with you: internal audits, management review, complaint handling, CAPA and supplier controls, so the site stays ready for the next customer or certification audit.
Receiving, storage, picking and shipping flow, inventory accuracy and cycle time, with the standard work and visual controls that keep the improvements in place.
In China
We have done the same work from the U.S. company's side: auditing Chinese suppliers, mapping evidence and remediating on site. Our Shenzhen team brings that experience to your side.
For FDA inspections and ISO 13485, MDSAP, UL and U.S. customer audits. We start from the actual audit notice and scope rather than a generic checklist, map the evidence, lead remediation at the factory, and run mock audits so your people can answer precisely from the record.
Learn about audit readinessFor private-label and ODM programs, we establish who is the specification developer, manufacturer, labeler and complaint owner, and put in writing which party owns, approves or can access design, changes, validation, supplier approval, complaints and records. Most outsourced programs are missing this document.
Since February 2, 2026, FDA's Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference. We map your existing procedures and executed records against the current requirements, separate procedures from evidence, keep the work already done, and rank remediation by regulatory risk.
Learn about the QMSR diagnosticYour U.S. customers can look up your public FDA status at any time: establishment registration (FEI), device listing, import alerts and inspection outcomes. Our Facility Compliance Engine checks these records weekly, so you can find and fix a problem before it affects shipments.
Learn about compliance monitoringWith the EquatorOps cross-company eQMS, you can give your U.S. customer a controlled quality portal for the agreed device family, sharing evidence, changes, actions and approvals while keeping your private manufacturing, supplier and commercial records.
Learn about the cross-company eQMSOur Shenzhen team works in Chinese at your factory, and our Orange County headquarters works with your customer during U.S. hours. Findings, remediation progress and change notices are explained clearly in both languages.
Deliverables
Each is a document or record you keep and can show to your U.S. customer and auditors.
How an engagement runs
Every engagement starts with the smallest fixed-scope piece of work that establishes the requirements, the roles and the real gaps, before you commit to anything larger.
Send us your customer's requirements and any prior findings. We can visit the site first to see the current situation, in Southern California or at other U.S. sites by arrangement.
We confirm the requirements, the roles and what each party is responsible for. You receive a written scope and fee before anyone commits.
We work at your U.S. site or your factory in China on procedures, records, training and corrective actions, and verify them on the floor.
Mock audit, evidence package, support during the audit when available, and corrective action follow-through until the findings are closed.
Send the audit report or requirements and the site location. We reply within 24 hours.