ISO Standards

Internal Audits: Are They Really Necessary? 

Q: Question regarding internal audits: is it acceptable for a manufacturing site to NOT have an established internal audit program? In place of internal audits, the manufacturing site uses the results of external audits conducted by regulatory authorities, standards assessment organizations,…

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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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CAPA Definitions as Used by FDA and ISO

CAPA definitions and terms can sometimes be confusing. Nearly everyone stumbles over the proper use and application of the CAPA terms of corrections, corrective actions, and preventive actions. The following CAPA definitions clarify the differences and are consistent with interpretations…

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