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How are nonconformances treated during the audit?

Nonconformances are either major or minor. If the registration audit reveals only minor non-conformances, the Lead Auditor will recommend registration – pending the closeout of corrective action. Objective evidence of corrective action can be submitted by mail or fax within 90 days of the audit; once accepted by the Lead Auditor, the registration certificate will be issued (and corrective action verified at the next required surveillance visit). For a major nonconformance, a revisit will be required to evaluate the corrective action, except in rare cases. The revisit will be limited to the area of nonconformance. In any case, the PJR audit will continue, even upon discovery of major nonconformances; you will be notified of any deficiencies in your quality system before the audit team leaves your facility. This written notification is part of the formal audit visit.

Posted in: Background