Tag Archive for Internal Audit

Management Reviews: A Checklist for Compliance

An effective and compliant Quality System must include periodic Management Reviews held at defined intervals of sufficient frequency. These reviews should include assessments of your processes, products, and customer needs. In addition, they should focus on the overall health and effectiveness…

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How Often Should You Conduct Internal Audits?

Q: I’ve found conflicting information on how frequently to perform internal audits. The ISO standards and the Quality System Regulation don’t have any frequency recommendations, but FDA’s Quality System Inspection Technique (QSIT) Guide recommends every 12 months. I’ve been in…

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Internal Quality Audits: What to Target

Q: With your experience as an FDA investigator and independent auditor, can you advise me on some specific things to look for when I’m conducting internal quality audits? A: First, make sure all your required Quality System procedures are defined,…

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