Curriculum
Internal audit, nonconformity, CAPA and management review [L-03]
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Start here
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Course pre-test
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Part I — Internal audit planning and conduct
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Part II — Nonconformity management
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Part III — Corrective and preventive action
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Part IV — Management review
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Course post-test
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Resources
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Capstone & certificate
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Text lesson
Chapter 1 · Internal audit planning and conduct
Internal audits must be planned in advance using an audit programme that covers all areas of the quality management system at defined intervals. Auditors must be trained and must not audit their own work. The audit must be documented: an audit plan, checklist, findings report, and a summary. Findings are classified as major nonconformities, minor nonconformities, or observations. The auditee must be given the findings report and given an opportunity to respond before it is finalised.
Practical example
The QM is scheduling the annual internal audit programme. Good practice: The QM assigns trained auditors to sections they do not work in, prepares checklists mapped to ISO 15189 clauses, schedules audit dates, and ensures findings are reported in writing within a defined timeframe. Poor practice: The QM audits their own section because ‘they know it best’ — this is not permitted; auditors must not audit their own work.
What this means for your practice: Internal audit independence is not optional. An auditor who audits their own work cannot be objective, and any findings from such an audit are invalid.