Results for “nonconformity”

Use this skill when an internal or external audit raised a nonconformity, finding, exception or observation and the team must answer it, or asks "write the corrective action plan", "root cause for this audit finding", "respond to the major nonconformity", "CAPA for the auditor", "how do we close this finding" or "the auditor rejected our corrective action". Separates correction from corrective action, runs a root cause analysis that stops at a cause the company controls, checks for the same problem elsewhere, and drafts a response with actions, owners, dates and the evidence that will prove effectiveness at the next audit.

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ISO 13485 internal audit expertise for medical device QMS. Use for audit planning and execution, nonconformity classification, CAPA verification, external audit preparation, or audit program management.

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Plan ISO 27001 information security audits, review evidence that security controls work, and document findings. The skill also helps classify failures, track corrective actions, and prepare documentation for certification audits.

• Planning an annual internal audit
• Reviewing evidence for Annex A controls
• Documenting findings and corrective actions

Plan and conduct internal audits for medical device quality management systems under ISO 13485. Organize evidence, classify findings, verify corrective and preventive actions, and prepare for external audits with structured checklists and risk-based scheduling.

• Plan an annual internal audit schedule
• Document audit evidence and classify findings
• Verify the effectiveness of corrective actions

Turns corrective and preventive actions from NCRs, audit reports, action forms, minutes or a tracker into one DRAFT tracker: action as stated, source, owner, due date, evidence expected and status, with flags for overdue, unowned, undated, stale and closed-without-evidence items and one question per flag. Never closes, verifies, reassigns or re-dates an action. Use when the user asks to "build the CAPA tracker", "update the corrective action log from these audit reports", "which actions are overdue or have no owner" or "draft the chase notes for open actions". Do not use for writing up the nonconformity itself, use nonconformance-report-drafter instead. Drafts for human review; never approves, authorises or signs off.

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