Audits

Internal Quality System Audits

Whether your own system does what your procedures say, tested by people who have been on the inside of inspections.

An internal audit answers a plain question: does your quality system do what your procedures say it does? We audit your system against the requirements that apply to you, current with the Quality Management System Regulation (QMSR).

We look at records, not only procedures. A procedure can read well and still not be followed. The audit shows where practice and paper part ways.

Findings come back ranked by risk, written so the owner of each one knows what is being asked, and handed over in a form that feeds your corrective action process directly.

Many companies audit only a sample and hope. We would rather tell you the whole picture, and the work to improve it, while you still control the timing.

When to call us

  • “Our quality system was built for 20 people and we are now 200.”
  • “We have not had an independent look at our system in years.”

Tell us what FDA, an auditor, or your own team found. We will tell you how we would handle it.

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